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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

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Powder Sampling and Particle Size Determination

Powder technology is a rapidly expanding technology and nowhere more than in particle characterization. There has been an explosion of new particle measuring techniques in the past ten year particularly in the field of on-line measurement. One of the main aims of this book is to bring the reader up-to-date with current practices. One important area of interest is the improvements in on-line light scattering instruments and the introduction of ultrasonic on-line devices. Another is the introduction of on-line microscopy, which permits shape analysis in conjunction with particle sizing.

Schools of powder technology are common in Europe and Japan but the importance of this subject has only recently been recognised in America with the emergence of the Particle Research Centre (PERC) at the University of Florida in Gainsville.

- Details all the latest developments in powder technology

- Written by established authority on powder technology

- A comprehensive text covering all aspects of powder technology and handling of particulate solids including characterization, handling and applications

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Drug Safety Evaluation

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated.

Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including:

  • Acute toxicity testing in pharmaceutical safety evaluation
  • Genotoxicity
  • Safety assessment of inhalant drugs
  • Immunotoxicology in pharmaceutical development
  • Large animal studies
  • Evaluation of human tolerance and safety in clinical trials
Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

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Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics(Biotechnology:Pharmaceutical Aspects)(Biotechnology:Pharmaceutical Aspects

Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

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Stability of Drugs and Dosage Forms

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.

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Handbook of Pharmaceutical Excipients

The Handbook of Pharmaceutical Excipients is a comprehensive, uniform guide to the uses, properties, and safety of pharmaceutical excipients. It collects in a systematic and unified manner, essential data on the physical and chemical properties of excipients. Information has been assembled from a variety of sources, including the primary literature and excipients manufacturers. Personal observations and comments from contributors are also included.

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Indian Medicinal Plants: An Illustrated Dictionary


In 2004, Springer-Verlag Heidelberg published C.P.Khare’s "Encyclopedia of Indian Medicinal Plants" which contained 400 monographs comprising classical as well as contemporary research findings.

"Indian Medicinal Plants. An Illustrated Dictionary" is the second major one-volume reference work by C.P.Khare which has been dedicated to the distinguished scientist, Dr. A.P.J.Abdul Kalam, who did pioneering work by reviving the glory of medicinal and aromatic plants in Rashtrapati Bhavan.

Scientific monographs of "The Wealth of India" series (17 volumes) have been capsulised in the dictionary and corroborated with the judicious findings of German Commission E, European Cooperative on Phytotherapy (ESCOP) and WHO. Therapeutic leads, active indications and contraindications are salient features of the core text. These are based on herbal pharmacopoeias, compendiums and latest editions of standard reference works like "PDR for Herbal Medicines," "(Laurance) Review of Natural Products", "Natural Medicines Comprehensive Database". Leads for further research have been provided at a number of places.

The Dictionary is the first updated source of Ayurvedic, Unani and Siddha synonyms of their botanical counterparts, after a gap of more than 30 years. The synonyms which appeared in "The Wealth of India" series (1948-1976) and in Chopra’s "Glossary of Indian Medicinal Plants" (1956) have been updated till January, 2007.

More than 2000 medicinal plants of "The Ayurvedic Formulary of India" and "The Ayurvedic Pharmacopoeia of India" and more than 100 species of non-Indian origin, incorporated in "National Formulary of Unani Medicine" have been covered in the Dictionary. Divergent sources of Ayurvedic, Unani and Siddha herbs have been identified and a number of controversies have been sorted out.

Pharmacognosy experts have selected important herbs, which were specially collected from leading pharamaceutical companies and pharmacopoeial laboratories and included in the dictionary as four colour photographs under the "Crude Herb Identification Guide" section. This is a unique feature and makes it an exclusive treat.

The Dictionary has been presented in a user-friendly format, as a compact, handy, easy to use and moderately priced one-volume reference work. It unfolds hidden virtues and potentials of Indian herbs for busy professionals, researchers, practitioners of herbal as well as modern medicine, and library frequenters. It will prove a ready information source for students of botany, economic botany, pharmacy, agricultural and medical sciences, who aspire to have an edge over others and are keen to keep themselves abreast of the times.

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Column Handbook for Size Exclusion Chromatography

Column Handbook for Size Exclusion Chromatography is the first comprehensive reference to provide everything one needs to know about commercial analytical and preparative columns for size exclusion and gel filtration chromatography (SEC and GFC). SEC is now widely used as a quality assurance method in the polymer industry (both synthetic and biopolymers) to determine molecular weight and molecular weight distribution. The Handbook contains contributions from every column manufacturer around the world and from many experienced column users. It covers the technology, characterization, application, evaluation, maintenance, and quality control of analytical and preparative columns for SEC and GFC. Also included are columns for two closely related techniques, hydrodynamic chromatography and high osmotic pressure chromatography.

Key Features
* Evaluate and select columns with confidence for specific applications
* Optimize separations and improve the ruggedness of analytical methods
* Extend the service time of a column
* Establish a quality-control program to ensure consistency in column performance
* Avoid the expense of column damage or purchases that do not give the expected results.

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Effective drug regulation: A multicountry study


Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided.

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Injectable Dispersed Systems: Formulation, Processing and Performance

This authoritative guide will serve as the most current source on the design and manufacturing of parenteral dispersed systems-showcasing the utility of dispersed systems in drug delivery, drug targeting, and pharmaceutical engineering.

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Batch Processes


Reduced time to market, lower production costs, and improved flexibility are critical success factors for batch processes. Their ability to handle variations in feedstock and product specifications has made them key to the operation of multipurpose facilities, and therefore quite popular in the specialty chemical, pharmaceutical, agricultural, and biotechnology-enabled products industries. The editors of Batch Processes analyze the design, development, operations, and control of batch processes - providing answers to the most challenging and pressing problems associated with their use. They present a reference unique in its coverage of both process design and operations management issues. Leading experts from industry and academia contribute chapters that discuss batch process scheduling, design software tools, and the latest technologies, their implementation, and their respective advantages. The book is presented in four parts for easy reference. Part I, Batch Processing General Overview, introduces the topic and discusses batch processing industries. Part II, Batch Processing Design Issues, includes information on conceptual design and synthesis, reactors in bioindustries, distillation, crystallization, and pollution prevention. Part III, Batch Processing Management, informs the reader on modeling and optimization, planning and scheduling, monitoring and control, and supply chain management. Part IV, Future of Batch Processing, offers concluding remarks and contemplates the future of batch processing.

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In Silico Technologies in Drug Target Identification and Validation

The pharmaceutical industry relies on numerous well-designed experiments involving high-throughput techniques and in silico approaches to analyze potential drug targets. These in silico methods are often predictive, yielding faster and less expensive analyses than traditional in vivo or in vitro procedures. In Silico Technologies in Drug Target Identification and Validation addresses the challenge of testing a growing number of new potential targets and reviews currently available in silico approaches for identifying and validating these targets. The book emphasizes computational tools, public and commercial databases, mathematical methods, and software for interpreting complex experimental data. The book describes how these tools are used to visualize a target structure, identify binding sites, and predict behavior. World-renowned researchers cover many topics not typically found in most informatics books, including functional annotation, siRNA design, pathways, text mining, ontologies, systems biology, database management, data pipelining, and pharmacogenomics. Covering issues that range from prescreening target selection to genetic modeling and valuable data integration, In Silico Technologies in Drug Target Identification and Validation is a self-contained and practical guide to the various computational tools that can accelerate the identification and validation stages of drug target discovery and determine the biological functionality of potential targets more effectively.

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Good Laboratory Practice Regulations, Fourth Edition

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

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Facility Validation: Theory, Practice, and Tools

Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and coverage of best practices for evaluating validation programs.

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Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Publisher:Pharmaceutical Press; Rev Ed edition( 27 April 2007) | ISBN-10: 0853697191 | PDF | 9.3 Mb | 430 pages

Since the 2002 edition of 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors', commonly known as the 'Orange Guide', there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community Code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.

From its first publication in 1971 the 'Orange Guide', has been an essential reference for all involved in the manufacture and distribution of medicines in Europe.

The 'Orange Guide' collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and to comply with legislation.

It is of particular relevance to all holders of Manufacturer’s Licences and Wholesale Dealer’s licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with many of these regulatory requirements.

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Gas Chromatography and Mass Spectrometry

This guide provides, under one cover, a wealth of practical information designed to facilitate the effectiveness of the GC/MS user. Separation conditions for numerous compound types are provided along with derivatized and underivatized compounds. A section on how to interpret mass spectral data, an extensive correlation of ion masses and neutral losses with possible structures, and examples of mass spectra are provided to further aid structure determination. Also included are basic information on instrumentation, ionization methods, quantitation, tips on the operation of mass spectrometers, the best derivatization procedures for a variety of compound types, troubleshooting techniques, and a variety of other information found to be useful to the practicing user of GC/MS instrumentation. This guide would be immediately valuable to the novice as well as the experienced GC/MS user who may not have the breadth of experience covered in this book.

Key Features:
* Condenses and organizes recent and essential information for new and experienced GC/MS users
* Comprehensively indexed and referenced
* Includes practical methods of analysis
* Serves as a text reference for short practical courses on the subject

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International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs, Fifth Edition


This book contains the English language texts of all GMPs, regulations, guidelines, codes, and practices implemented by national and international regulatory authorities that govern the manufacture and testing of biotechnology-derived products, active pharmaceutical ingredients, and pharmaceuticals. Prepared with the cooperation of health authorities worldwide, this resource contains the GMPs in effect in 114 countries, plus GMP regulations of the World Health Organization, including the 1996 WHO GMPs, the European Union, the Association of South East Asian Nations, and the Pharmaceutical Inspection Convention.

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PART - I : http://rapidshare.com/files/46920750/International_Biotechnology_and_Pharmaceutical_GMPS.part1.rar

PART - II: http://rapidshare.com/files/47045149/International_Biotechnology_and_Pharmaceutical_GMPS.part2.rar