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Good Pharmacovigilance Practice Guide

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions.The MHRA has identified a need for writing and publishing a guide to "Good Pharmacovigilance Practice". This text complements current legislation and guidance, and provides practical advice about achieving an appropriate system of pharmacovigilance.

Pericyclic Reactions (Oxford Chemistry Primers, 67)

Pericyclic reaction - the third type of organic reaction mechanism along with ionic and radical reactions - include some of the most powerful synthetically useful reactions, like the Diels - Alder reaction, 1,3- dipolar cycloadditions, the Alder ene reaction, Claisen rearrangements, the 2,3-Wittig rearrangement, diimide reduction, sulfoxide elimination and many others. These reactions are characterised by having cyclic transition structures, and also have highly predictable stereochemical features. Every organic chemist must be able to recognise the various types of pericyclic reaction and know something of their mechanisms and the factors that affect how well they work in organic synthesis. This book identifies the four main classes of pericyclic reaction, and discusses the main characteristics of the most important class, cycloadditions - providing a working knowledge, based on real examples, of their scope, patterns of reactivity, and stereochemistry. Then it explains the main features using ideas based in molecular orbital theory, but ( as in the companion book by A. J. Kirby on Stereoelectronic Effects ) without mathematics. It presents the Woodward - Hoffmann rules in the form of two all-encompassing rules, one for thermal reactions and its opposite for photochemical reactions. These rules are explained in detail and carefully illustrated, so that you will be able to predict the stereochemical outcome for any pericyclic reaction. The remaining chapters use this theoretical framework to show how the rules work with the other three classes of pericyclic reactions - electrocyclic reactions, sigmatropic rearrangements and group transfer reactions. By the end of the book, you will be able to recognise any pericyclic reaction and predict with confidence whether it is allowed, and with what stereochemistry, and you will have a working knowledge of the range of pericyclic reactions available to the synthetic organic chemist.

Drug-like Properties: Concepts, Structure Design and Methods: from ADME to Toxicity Optimization

Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process.

The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties.

* Serves as an essential working handbook aimed at scientists and students in medicinal chemistry
* Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies
* Discusses improvements in pharmacokinetics from a practical chemist's standpoint.

Stockley's Drug Interactions 2009 Pocket Companion

This new edition continues to provide the busy health care professional with a small and conveniently sized quick reference "Stockley" text. "Stockley's Drug Interactions Pocket Companion 2009" draws on the wealth of clinically evaluated, evidence-based information on drug-drug, drug-herb and drug-food interactions that is presented in the full reference work, "Stockley's Drug Interactions".

Stockley’s Drug Interactions Pocket Companion 2009 provides busy healthcare professionals with a small and conveniently sized, quick-reference Stockley text. It draws on the wealth of clinically evaluated, evidence-based information on drug-drug, drug-herb and drug-food interactions that is presented in the full reference work, Stockley’s Drug Interactions .: Follows the familiar format of the Stockley products; Includes over 1500 interaction monographs pertaining to specific drugs or drug groups; Arranged alphabetically for ease of searching; Contains a comprehensive index; Easy-to-use severity rating symbols offer guidance to the user on the clinical significance of the interaction; An essential clinical reference for physicians, pharmacists, nurses and other healthcare professionals. Due to the wide international appeal of this content, the text is now translated into Spanish, Italian and Japanese.

Pharmaceutical Manufacturers: An International Directory

This international directory of pharmaceutical manufacturers includes 1,046 firms in 50 countries. They are arranged alphabetically by country and company name.

In addition to name and address, other information such as telephone and fax number, and key personnel are also listed, where available.

Completing the directory, is a listing of 124 Contract Manufacturers in 19 countries of ethical and/or non-prescription pharmaceuticals. These are arranged alphabetically by country and company name.


Name Reactions and Reagents in Organic Synthesis

This Second Edition is the premier name resource in the field. It provides a handy resource for navigating the web of named reactions and reagents. Reactions and reagents are listed alphabetically, followed by relevant mechanisms, experimental data (including yields where available), and references to the primary literature. The text also includes three indices based on reagents and reactions, starting materials, and desired products. Organic chemistry professors, graduate students, and undergraduates, as well as chemists working in industrial, government, and other laboratories, will all find this book to be an invaluable reference.


Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook, Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical Justify Fullmaterials, drugs and devices.


Pharmaceutics: The Science of Dosage Form Design

A comprehensive textbook covering the design of dosage forms and all aspects of drug delivery systems. 'Pharmaceutics' in its broadest sense is the 'art of the apothecary' or, in simple terms, pharmaceutical preparations. It remains a diverse subject in the pharmacy curriculum, encompassing design of drugs, their manufacture, and the elimination of micro-organisms from the products. This books encompasses all those areas and pays particular attention to the design of dosage forms and their manufacture.


Clinical Pharmacology Made Incredibly Easy!

Clinical Pharmacology Made Incredibly Easy! Third Edition contains everything the health care practitioner needs to review and the student needs to learn about how drugs act and interact in the treatment of disease. The book focuses on mechanisms of drug action; details specific drugs by pharmacologic class for all body systems, plus pain medications, anti-infective drugs, and cancer drugs; and highlights potentially dangerous interactions, including drug-herb interactions. The book pulls together all the necessary facts about drug actions and interactions and presents them with the lighthearted Incredibly Easy! style and tone that makes intimidating concepts thoroughly approachable, easily grasped, and readily retained.


MCQs in Biochemistry

Competitive Examinations are the order of the day. All Colleges conducting professional courses at PG level are admitting students based on common entrance examination, which is of objective type. In Pharmacy, M.Pharm admissions are based on qualifying the GATE enterance examination conducted by Govt. of India. In this book, The author has done good work in preparing several objective questions which help the students to face the subject in the examination with poise and confidence. The book is well balanced and consists of multiple choice questions from all the important topics like carbohydrate metabolism and other important Biochemical aspects. The typesetting and quality of printing is good. The author is also well experienced in taking up this type of work. I recommend this book to all the students preparing for GATE examination and also for Medical and Pharmacy College libraries.


Air Quality, 4th Edition

Ozone-destroying chemicals, greenhouse gases, and dangerous airborne substances that were once thought to be benign are the most urgent issues facing air pollution control experts. Students need a thorough, updated reference that explores these current trends while also covering the fundamental concepts of this emerging discipline. A new revision of a bestseller, Air Quality, Fourth Edition provides a comprehensive overview air quality issues, including a better understanding of atmospheric chemistry, the effects of pollution on public health and the environment, and the technology and regulatory practices used to achieve air quality goals. New sections cover toxicological principles and risk assessment. The book also contains revised discussions on public policy concerns, with a focus on air quality standards for ozone depletion and global warming, and the health effects of particulate air pollutants. This edition continues to serve as a very readable text for advanced level undergraduate and early graduate study in environmental science, environmental management, and in programs related to the study of public health, industrial hygiene, and pollution control.

Powder and Bulk Engineering International July 2009


Pharmaceutical Product Branding Strategies: Simulating Patient Flow and Portfolio Dynamics, Second Edition

This updated Second Edition details how marketers, forecasters, and brand planners can achieve optimal success by building internally consistent simulation models to project future behavior of patients, physicians, and R&D processes. By introducing the reader to the complexities facing many pharmaceutical firms, specifically issues around cross-functional coordination and knowledge integration, this guide provides a framework for dynamic modeling of interest to several pharmaceutical markets, including epidemiology, market definitions, compliance/persistency, and revenue generation in the context of patient flows or movements.

Design and Analysis of Animal Studies in Pharmaceutical Development

This practical resource provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products! Clarifying detailed presentations with real-world examples, Design and Analysis of Animal Studies in Pharmaceutical Development furnishes definitions, background information, and regulatory requirements discusses statistical designs and methods for bioassay describes techniques for estimating drug efficacy and lethal doses illustrates statistical concepts as well as design and analysis principles for toxicology studies shows how to assess carcinogenicity and teratology for drugs under development details methods of analysis for in vitro Ames tests and Chinese hamster ovary cell mutagenesis studies and more!

The Clinical Audit in Pharmaceutical Development

MORIAH Consultants, Yorba Linda, CA. Addresses current issues and trends in the validation and auditing of a clinical study. Covers the concepts of clinical studies and data verification and validation, including the general concept of Good Clinical Practice (GCPs), monitoring, and the role of agencies.

New Drug Approval Process: The Global Challenge

"This text [is] a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." -- Journal of Medicinal Chemistry

"…very valuable…
"…should be a required reading….highly recommended." -- Guarino

"…very valuable… "…should be a required reading for anyone entering the strait-jacket world of modern pharmaceutical development….highly recommended. -- Pharmaceutical Development and Technology

Oxford Pharmaceutical Resources, Inc., Totowa, NJ. Covers the new emphasis on over-the-counter drugs, latest techniques of institutional review boards, Good Clinical Practice standards set by the FDA, adverse drug reaction standards, and more. For professionals in pharmaceutical industry.

Filtration in the Biopharmaceutical Industry

This timely resource offers comprehensive examinations of the most recent developments in the field, from prefiltration methods to final, gas, and tangential flow filtration techniques. Delineates filtration in a host of applications, including virus removal, protein binding, and sterility testing and introduces new, membrane-based technologies for the biopharmaceutical industry! Addressing quality, security, economic, process development, and regulatory topics, Filtration in the Biopharmaceutical Industry presents pre- and sterility grade filters, charge-modified filter media, and aids to filtration discusses filter quality assurance, pore size, extractables, and compatibilities in various filters examines filter design and construction analyzes integrity testing, test sensitivity, and automation furnishes novel filtration flow methods explains filter validation summarizes the U.S. Food and Drug Administration regulations governing filtration and more!