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Drug Delivery and Targeting: For Pharmacists and Pharmaceutical Scientists

The advances in biotechnology and molecular biology over recent years have resulted in a large number of novel molecules with the potential to revolutionize the treatment and prevention of disease. However, such potential is severely compromised by significant obstacles to delivery of these drugs in vivo. These obstacles are often so great that effective drug delivery and targeting is now recognized as the key to effective development of many therapeutics. 

Advanced drug delivery and targeting can offer significant advantages to conventional drugs, such as increased efficiency, convenience, and the potential for line extensions and market expansion. An accessible and easy-to-read textbook, Drug Delivery and Targeting for Pharmacists and Pharmaceutical Scientists is the first book to provide a comprehensive introduction to the principles of advanced drug delivery and targeting, their current applications and potential future developments, including:

*Methods to optimize therapeutic efficacy, and the related commercial implications
*Difficulties with drug absorption, unwanted distribution and premature inactivation / elimination
*Attempts to minimize toxicity or alter immunogenicity
*Methods to achieve rate-controlled drug release and effective drug targeting
*Novel and established routes of delivery 
*Use of new generation technologies such as biosensors, microchips, stimuli-sensitive hydrogels and plasmid-based gene therapy

This volume is indispensable for pharmaceutical students, scientists and researchers.

Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products (Volume 4 of 6)

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and the BASF book of generic formulations. Each entry begins with a fully validated scaleable manufacturing formula that includes compendial specification requirement for each ingredient, in-process controls for manufacturing and release of product, a summary of manufacturing process, and details of packaging.

Handbook Of Pharmaceutical Excipients, By Raymond C Rowe And Paul J Sheskey

Pharmaceutical dosage forms contain both pharmacologically active compounds and excipients added to aid the formulation and manufacture of the subsequent dosage form for administration to patients. Indeed, the properties of the final dosage form (i.e. its bioavailability and stability) are, for the most part, highly dependent on the excipients chosen, their concentration and interaction with both the active compound and each other.

No longer can excipients be regarded simply as inert or inactive ingredients, and a detailed knowledge not only of the physical and chemical properties but also of the safety, handling and regulatory status of these materials is essential for formulators throughout the world. In addition, the growth of novel forms of delivery has resulted in an increase in the number of the excipients being used and suppliers of excipients have developed novel excipient mixtures and new physical forms to improve their properties. The Handbook of Pharmaceutical Excipients has been conceived as a systematic, comprehensive resource of information on all of these topics

Pharmaceutical Preformulation And Formulation, By Mark Gibson

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry. Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses: candidate drug selection drug discovery and development preformulation predictions and drug selections product design to commercial dosage form biopharmaceutical support in formulation development and more.

Advanced Pharmaceutics: Physicochemical Principles

Discussing a comprehensive range of topics, Advanced Pharmaceutics: Physicochemical Principles reviews all aspects of physical pharmacy. The book explains the basic, mechanistic, and quantitative interpretation skills needed to solve physical pharmacy related problems. The author supplies a strong fundamental background and extensively covers thermodynamics, ionic equilibria, solutions and distribution, surface chemistry and colloids, kinetics, diffusion, and polymer science. 

He outlines the latest research on diffusion through a membrane and the use of polymers in dosage forms.Packed with formulae and models, the book demonstrates the development of each and then describes the use of those models for a variety of formulation situations. The author's detailed explanation of the evolution of the formulae provides a clear understanding of when and how they are used. This bottom-up approach delineates the evolution of the formulae and gives a clear understanding of when and how they should be used. The book provides an in-depth review and analysis of dosage form design criteria that you can rapidly implement in your day-to-day work.

Modern Pharmaceutics Fourth Edition

"Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration."

Active Pharmaceutical Ingredients Development, Manufacturing And Regulation, By Stanley H. Nusim

Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.

Remington: The Science and Practice of Pharmacy [PDF]

For over 100 years, Remington has been the definitive textbook and reference on the science and practice of pharmacy. This Twenty-First Edition keeps pace with recent changes in the pharmacy curriculum and professional pharmacy practice.

More than 95 new contributors and 5 new section editors provide fresh perspectives on the field. New chapters include pharmacogenomics, application of ethical principles to practice dilemmas, technology and automation, professional communication, medication errors, re-engineering pharmacy practice, management of special risk medicines, specialization in pharmacy practice, disease state management, emergency patient care, and wound care.

A Textbook Of Pharmaceutical Analysis, 3rd Edition

This book is a detailed, systematic treatment of analytically chemistry, focusing on drug analysis. It covers both classical techniques and modern approaches. It includes new sections on immunoassay, derivative formation, and statistical interpretation of data. Also includes an expanded treatment of liquid chromatography, as well as over 250 problems, many with solutions provided.

Martindale: The Complete Drug Reference, 36th Edition

This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".

Latest ICH Guidelines

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.

Quality Guidelines:

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Safety Guidelines:

ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

Efficacy Guidelines:

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.

Multidisciplinary Guidelines:

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

British Pharmacopoeia 2013

The British Pharmacopoeia (BP) 2013 is the leading collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.

Global standards

Now used in over 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture and testing around the globe.

Flexible access options

The BP 2013 package comprises five volumes of the British Pharmacopoeia 2013 and a single volume of the British Pharmacopoeia (Veterinary) 2013, along with a fully searchable CD-ROM and online access to provide you with flexible resources.

New for 2013

Legally effective from 1 January 2013
41 new BP monographs
40 new European Pharmacopoeia monographs
619 amended monographs
6 new and 1 amended Infrared Reference Spectra
European Pharmacopoeia 7th edition material up to and including Supplement 7.5
Free in-year updates in January, April and July to harmonise with the European Pharmacopoeia

Indian Pharmacopoeia 2010 [ 3 Volume Set - PDF ]

The 6th edition of the Indian Pharmacopoeia 2010 is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a plan and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about two years. It supersedes the 2007 edition but any monograph of the earlier edition that does not figure in this edition continues to be official as stipulated in the Second Schedule of the Drugs and Cosmetics Act, 1940. This edition would be effective from 1st September, 2010.

The Indian Pharmacopoeia 2010 is presented in three volumes. Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction, and the General Chapters. Volume II contains the General Notice, General Monographs on Dosage Forms, Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume III contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by Monographs on Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary products.

The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition. The number of monographs of Excipients, Anticancer drugs, Herbal products and Antiretroviral drugs have been increased in this edition. Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. A chapter on NMR is incorporated in Appendices. The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international requirements.

Medicinal Chemistry - By Ashutosh Kar

This is the forth edition of a book written to serve both as a useful textbook for undergraduate courses in medicine and pharmacology, and also as a handy reference title for industry professionals. Each of the 27 chapters is sub-divided into 3 sections: 

(i) an introduction to the subject, 
(ii) a chemical or pharmacological classification -– each category of compound importantly contains International Non-proprietory Names (INN), British Approved Names (BAN) and United States Approved Names (USAN) wherever applicable, chemical names and proprietory names. 
(iii) the synthesis of various important members treated individually, a brief description of the synthesis, therapeutic applications of each compound, the necessary dosage applied in various diseases, and routes of administration. 

The book also deals well with the comprehensive mechanism of actions of the structure -– activity -– relationships (SARs); thus aiding the students’ understanding. Clearly written, well referenced and fully up to date with recommended readings and self assessment questions, Prof. Kar has provided an accessible text book for students of medicinal chemistry. 

Boronic Acids: Preparation and Applications in Organic Synthesis and Medicine

For the first time, the whole field of organoboronic acids is presented in one comprehensive handbook.
Professor Dennis Hall, a rising star within the community, covers all aspects of this important substance class, including applications in chemistry, biology and medicine.

Starting with an introduction to the structure, properties, and preparation of boronic acid derivatives, together with an overview of their reactions and applications, the book goes on to look at metal-catalyzed borylation of alkanes and arenas, coupling reactions and rhodium-catalyzed additions of boronic acids to alkenes and carbonyl compounds. There follows chapters on copper-promoted C-O and C-N cross-coupling of boronic acids, recent applications in organic synthesis, as well as alpha-haloalkylboronic esters in asymmetric synthesis. Later sections deal with cycloadditions, organoboronic acids, oxazaborolidines as asymmetric inducers, and boronic acid based receptors and sensors. The whole is rounded off with experimental procedures, making this invaluable reading for organic, catalytic and medicinal chemists, as well as those working in organometallics.

System of preliminary scrutiny by CDSCO at the time of receipt of application for approval of Fixed Dose Combinations

Fixed Dose Combinations (FDCs) refer to products containing two or more active ingredients used for a particular indication(s). As per Rule 122-E of Drugs & Cosmetics Rule, A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration are considered new drugs.

Further, a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. The development of FDCs is becoming increasingly high either to improve compliance or to benefit from the added effects of the two or more active drugs given together. They are being used in the treatment of a wide range of conditions and are particularly useful in the management of chronic conditions.

Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.

Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues
Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements
Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries
Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization
Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate

The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance. 

Effect Of Food On Pharmacokinetics Of Meloxicam

The primary objective of the study was to investigate the effect of food on the pharmacokinetics of MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessmentof bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence between administration in fasting and fed conditions. 

21 Cfr Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

In the FDA regulated environment, it is not acceptable for programmers or their managers to deviate from standardized methodologies. Given the type of software commonly found in FDA regulated operations, the criticality and complexity of computer systems, the evolving regulatory climate, and the current industry best practices, validating computer systems can be problematic. Covering regulatory requirements stipulated by FDA and GAMP guidelines, 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. Whether you need to validate computer systems for pharmaceutical cosmetic, food, or medical devise applications, this book is indispensable. Discussing the regulatory requirements that are the foundation for any project, the book introduces a model that can be used to determine the Part 11 requirements for consideration during implementation. The book establishes a top-down approach to the integration of computer systems validation strategies in support of a computer systems validation project. It focuses on practical issues in computer systems implementation and operational life project management, including relevant activities to comply with Part 11, validation planning, and scheduling. The book reviews documentation in relation to CSV and procedural controls in regulated operations. The book shows how to enable compliance with computer systems validation requirements while highlighting and integrating Part 11 requirements into the entire computer validation program. The author places regulatory compliance within the context of quality assurance and emphasizes the importance of integrating validation into the system life cycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance.

Handbook of Food Factory Design

Food manufacturing has evolved over the centuries from kitchen industries to modern, sophisticated production operations. A typical food factory includes the food processing and packaging lines, the buildings and exterior landscaping, and the utility-supply and waste-treatment facilities. As a single individual is unlikely to possess all the necessary skills required to facilitate the design, the task will undoubtedly be undertaken by an interdisciplinary team employing a holistic approach based on a knowledge of the natural and biological sciences, most engineering disciplines, and relevant legislation. In addition, every successful project requires a competent project manager to ensure that all tasks are completed on time and within budget. 

This Handbook attempts to compress comprehensive, up-to-date coverage of these areas into a single volume. It is hoped that it will prove to be of value across the food-manufacturing community. The multi-disciplinary nature of the subject matter should facilitate more informed communication between individual specialists on the team. It should also provide useful background information on food factory design for a wider range of professionals with a more peripheral interest in the subject: for example, process plant suppliers, contractors, HSE specialists, retailers, consultants, and financial institutions. Finally, it is hoped that it will also prove to be a valuable reference for students and instructors in the areas of food technology, chemical engineering, and mechanical engineering, in particular.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

This book describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world. 

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low and middle income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. 
Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. 

Acronyms and Abbreviations
Front Matter
1 Introduction
2 Core Elements of Regulatory Systems
3 Critical Issues
4 A Strategy to Building Food and Medical Product Regulatory Systems
5 International Action
6 Domestic Action
7 Conclusions and Priorities

Appendix A Glossary
Appendix В A Review of Tort Liability's Role in Food and Medical Product Regulation
Appendix С Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China
Appendix D Chinese Food Regulatory System
Appendix E Meeting Agendas
Appendix F Committee Member Biographies
Appendix G Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed
Appendix H Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration

Handbook of Medical Device Regulatory Affairs in Asia

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. 

A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors.

Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Clarke's Analysis of Drugs and Poisons, 4th Edition

Clarke's Analysis of Drugs and Poisons, 4th Edition is now being offered solely as a print and online package. It is a full book & digital package, consisting of the two volume reference book in a slip case, plus one year's individual access to the online version of Clarke's via Medicines Complete, with all the attendant benefits, including updating annually.

MedicinesComplete is produced and updated by Pharmaceutical Press.

Clarke's Analysis of Drugs and Poisons is the definitive source of analytical data for drugs and poisons. Written by over 40 international experts, the resource also boasts an editorial advisory board of over 45 world renowned scientists.

This reference work has been completely revised and updated for the new edition, and comprises two volumes.

The book is essential for all forensic and clinical toxicologists, pathologists, hospital pharmacists, pharmaceutical analysts, clinical pharmacologists, clinical and forensic laboratories, and poison information centers.

Molecular Pharmacognosy

"Molecular Pharmacognosy” discusses the application of molecular biology in resource science and authentication of traditional Chinese medicine (TCM). This book reviews the latest developments in pharmacognosy, introduces a series of new views and insights, presents the hotspots and focus of the field of study on molecular pharmacognosy, and predicts a new direction of study on the resource science of TCM. Furthermore, the book also provides an open communications platform for the development of molecular pharmacognosy. 

This book is intended for biomedical scientists and researchers in the fields of molecular biology, traditional medicine and natural pharmaceutics. Professor Lu-qi Huang is Director of the Collaborating Centre of the World Health Organization for Traditional Medicine (Chinese Materia Medica) and Vice-Chairman of the Australia Chinese Association for Biomedical Sciences Inc.

Encyclopedia of Analytical Science, 2nd Edition

As with the first edition of the Encyclopedia of Analytical Science, this second edition is designed to provide a detailed and comprehensive publication covering all facets of the science and practice of analysis. The new work has been extensively revised in terms of the titles and content of the first edition, and includes comprehensive coverage of techniques used for the determination of specific elements, compounds and groups of compounds, in physical or biological matrices.

Clinical Pharmacology Made Incredibly Easy

Written in the award-winning Incredibly Easy style, this book provides complete and clear explanations of how drugs act and interact in the treatment of disease. Focusing on mechanisms of drug action, the book details specific drugs by pharmacologic class for all body systems as well as drugs for pain, psychiatric disorders, infection, fluid and electrolyte imbalances, and cancer. 

Potentially dangerous drug and drug-herb interactions are highlighted. This thoroughly updated edition covers the newest drugs in each pharmacologic class and includes information on obesity drugs, a new chapter on genitourinary system drugs, a new medication safety feature, and a new appendix on common herbal preparations and their drug interactions.

Medical Statistics: A Guide to Data Analysis and Critical Appraisal

This hands-on guide is much more than a basic medical statistics introduction. It equips you with the statistical tools required for evidence-based clinical research.

Each chapter provides a clear step-by-step guide to each statistical test with practical instructions on how to generate and interpret the numbers, and present the results as scientific tables or graphs.

Applied Pharmacology for Veterinary Technicians

Designed specifically for veterinary technicians, this essential resource offers detailed guidance on key topics such as managing medication inventory, dispensing veterinarian prescribed drugs, calculating drug dosages, administering medications to animals, and educating clients about drug side effects and precautions. 

Up-to-date drug information is presented in a consistent, easy-to-use format that includes pharmacokinetics, pharmacodynamics, clinical uses, dosage forms, and adverse side effects. Illustrated, step-by-step procedures demonstrate proper administration techniques for common drug forms.

Forecasting for the Pharmaceutical Industry: Models for New Product And In-market Forecasting And How to Use Them

In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. 

The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex 'black box' equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Art Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. 

The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. "Forecasting for the Pharmaceutical Industry" is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making.

Advances in Food and Nutrition Research Volume 41 Starch: Basic Science to Biotechnology

This volume presents the physiological and biochemical aspects of storage carbohydrates, or starch granules, in plants. This up-to-date and thorough resource carefully integrates fundamental knowledge with the most recent information on the starch granule. 

It discusses the chemistry of the starch granule and the biochemistry, molecular biology, plant physiology, and genetics of plant starch synthesis. The books also describes the implications of these studies for theseed, biotechnology, and modified starch industries.

Gareth Thomas, "Medicinal Chemistry: An Introduction"

Medicinal Chemistry: An Introduction, Second Edition provides a comprehensive, balanced introduction to this evolving and multidisciplinary area of research. Building on the success of the First Edition, this edition has been completely revised and updated to include the latest developments in the field.

Written in an accessible style, Medicinal Chemistry: An Introduction, Second Edition carefully explains fundamental principles, assuming little in the way of prior knowledge. The book focuses on the chemical principles used for drug discovery and design covering physiology and biology where relevant. It opens with a broad overview of the subject with subsequent chapters examining topics in greater depth.

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives. 

The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices.

With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.

Progress in Inorganic Chemistry, Dithiolene Chemistry: Synthesis, Properties, and Applications

"Dithiolene metal complexes have a history going back to the 1960's (at least). But, interest in such compounds faded by the seventies. However, there has been a major resurgence, just in the last very few years, and a number of research groups have found exciting new properties (i.e., photochemistry, luminescence), applications as sensors and new materials of industrial interest. 

Moreover, very recent (in the last five years, or less) biochemical insights have revealed that dithiolene-metal complexes exist in nature, in certain enzyme active sites. Thus, a segment of the biochemical and (bio)inorganic chem istry community is currently devoting considerable attention to inorganic synthetic, theoretical and other aspects of dithiolene coordination chemistry."

The Design and Manufacture of Medical Devices

Medical devices are included in the fields of medical and health technology and encompass a wide range of health care products. Today, it is difficult to obtain an exact definition of "medical device." Directive 2007/47/EC, for example, defines a medical device as, "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings." 

This book brings together a range of articles and case studies dealing with medical device R&D. Chapters cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems.

Melloni's Pocket Medical Dictionary: Illustrated

The Melloni series of medical dictionaries are famous for their concise definitions and detailed illustrations. And Melloni's Pocket Medical Dictionary: Illustrated is no exception. A condensed and portable version of the award-winning and highly acclaimed Mellonis's Illustrated Medical Dictionary, the book features a wide range of beautifully drawn and carefully labeled illustrations to accompany the large number of expert and concise medical definitions. The pocketbook takes the most important qualities of the 4th Edition, reduces its size without sacrificing accuracy and clarity, and adds the most current information. When you can't take the big book with you, this book provides the information you need where you need it.

Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals) by WHO

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel.

Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.

National Formulary of India (NFI 2011, 4th Edition)

The National Formulary of India is essentially meant for the guidance of the members of the medical profession; medical students, nurses and pharmacists working in hospitals and in sales establishments. In the preparation of this Formulary, the expert opinion of medical practitioners, teachers in medicine, nurses, pharmacists and Pharmaceutical manufacturers has been obtained. The selection of drugs for inclusion in the National Formulary has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country. Thus the National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the physician with carefully selected therapeutic agents of proved effectiveness which form the basis of national drug therapy.

As more than three decades have elapsed since the publication of the last edition of the National Formulary of India, it is to be expected that This 4th edition of NFI would have many distinct features to promote the rational use of medicines in the country.

The formulations included in the Formulary and the ingredients thereof should conform to the standards laid down in the current edition of the Indian Pharmacopoeia. If no standards are specified in the current edition but are specified in the immediately preceding edition of the Indian Pharmacopoeia then these standards would apply. In respect of drugs for which no standards have been laid down in the Indian Pharmacopoeia, these would have to conform to the standards laid down in the official pharmacopoeia of any other country wherein they are included. The provisions of the Drugs and Cosmetics Act and the Rules made thereunder including those relating to labeling and conditions of storage should be observed.

Contents: Preface.  Acknowledgements. 1. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDS). 2. Antacids and antiulcer Drugs. 3. Antiallergics and drugs used in anaphylaxis. 4. Anti-Alzheimer and anti-parkinsonism drugs. 5. Anticonvulsants/antiepileptics. 6. Antidiarrhoeals and laxatives. 7. Antidotes and substances used in poisoning. 8. Antiemetics. 9. Anti-infectives. 10. Antimigraine drugs. 11. Antineoplastics and immunosuppressives. 12. Antiseptics and disinfectants. 13. Cardiovascular drugs. 14. Dermatological drugs. 15. Diagnostic agents. 16. Dialysis fluids. 17. Disease modifying anti-rheumatic drugs (DMARDs) and Drugs for Gout. 18. Diuretics. 19. Drugs in Osteoporosis. 20. Drugs for anaesthesia. 21. Drugs for inflammatory Bowel disease. 22. Drugs for Myasthenia Gravis. 23. Drugs for respiratory diseases. 24. Hormones, contraceptives and related drugs. 25. Immunologicals. 26. Muscle relaxants. 27. Ophthalmological preparations. 28. Psychotherapeutic drugs. 29. Solutions correcting water, electrolyte and acid base disturbances. 30. Vitamins, minerals and antianaemic drugs. Appendices. Index.