Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection

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Author :
Publisher : World Health Organization
ISBN 13 : 9240086080
Total Pages : 1354 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection by : World Health Organization

Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance

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Author :
Publisher : World Health Organization
ISBN 13 : 9240099425
Total Pages : 1788 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance by : World Health Organization

Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance written by World Health Organization and published by World Health Organization. This book was released on 2024-10-24 with total page 1788 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.

Handbook of Pharmaceutical Excipients

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Publisher : Amer Pharmacists Assn
ISBN 13 : 9781582121352
Total Pages : 888 pages
Book Rating : 4.1/5 (213 download)

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Book Synopsis Handbook of Pharmaceutical Excipients by : Raymond C. Rowe

Download or read book Handbook of Pharmaceutical Excipients written by Raymond C. Rowe and published by Amer Pharmacists Assn. This book was released on 2009-01-01 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.

Drug-Induced Liver Injury

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Publisher : Academic Press
ISBN 13 : 0128173173
Total Pages : 290 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Drug-Induced Liver Injury by :

Download or read book Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series

Marijuana and Medicine

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Publisher : National Academies Press
ISBN 13 : 0309071550
Total Pages : 288 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Marijuana and Medicine by : Institute of Medicine

Download or read book Marijuana and Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-10 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.

The Use of Drugs in Food Animals

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Publisher : National Academies Press
ISBN 13 : 0309175771
Total Pages : 276 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Use of Drugs in Food Animals by : National Research Council

Download or read book The Use of Drugs in Food Animals written by National Research Council and published by National Academies Press. This book was released on 1999-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

Compendium of Pharmaceuticals and Specialties

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Publisher :
ISBN 13 :
Total Pages : 2032 pages
Book Rating : 4.7/5 (966 download)

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Book Synopsis Compendium of Pharmaceuticals and Specialties by : Canadian Pharmaceutical Association

Download or read book Compendium of Pharmaceuticals and Specialties written by Canadian Pharmaceutical Association and published by . This book was released on 1995 with total page 2032 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Compounding Sterile Preparations

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Publisher : ASHP
ISBN 13 : 1585286508
Total Pages : 1069 pages
Book Rating : 4.5/5 (852 download)

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Book Synopsis Compounding Sterile Preparations by : Ryan Forrey

Download or read book Compounding Sterile Preparations written by Ryan Forrey and published by ASHP. This book was released on 2023-11-13 with total page 1069 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of Compounding Sterile Preparations by Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv reflects the latest advancements in the field, providing you with an indispensable resource to navigate the complex landscape of sterile compounding. New in this Edition: Updated Standards: All chapters have undergone extensive revisions to align with the most recent literature and the revised USP standards. USP Chapter : Now includes information on radiopharmaceutical compounding in USP Chapter . Expanded Knowledge Base: Two brand-new chapters covering Allergenic Extracts and Corrective and Preventative Action (CAPA) Plans.

The Cumulative Book Index

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Publisher :
ISBN 13 :
Total Pages : 2248 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Cumulative Book Index by :

Download or read book The Cumulative Book Index written by and published by . This book was released on 1996 with total page 2248 pages. Available in PDF, EPUB and Kindle. Book excerpt: A world list of books in the English language.

Statistical Reference Index

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Publisher :
ISBN 13 :
Total Pages : 986 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Statistical Reference Index by :

Download or read book Statistical Reference Index written by and published by . This book was released on 1994 with total page 986 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regulatory Affairs in the Pharmaceutical Industry

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Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali

Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Clarke's Analytical Forensic Toxicology

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Publisher : Pharmaceutical Press
ISBN 13 : 0857110543
Total Pages : 657 pages
Book Rating : 4.8/5 (571 download)

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Book Synopsis Clarke's Analytical Forensic Toxicology by : Gail Cooper

Download or read book Clarke's Analytical Forensic Toxicology written by Gail Cooper and published by Pharmaceutical Press. This book was released on 2013-05-28 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: This invaluable textbook, written by international experts, covers all the main elements of forensic toxicology and analytical toxicology techniques as well as the important parts of pharmacokinetics, drug metabolism, and pharmacology in general, with a particular focus on drugs of abuse.

Poisoning & Toxicology Compendium

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Publisher :
ISBN 13 :
Total Pages : 1480 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis Poisoning & Toxicology Compendium by :

Download or read book Poisoning & Toxicology Compendium written by and published by . This book was released on 1998 with total page 1480 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Aulton's Pharmaceutics

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Publisher : Elsevier Health Sciences
ISBN 13 : 0702042900
Total Pages : 909 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Aulton's Pharmaceutics by : Michael E. Aulton

Download or read book Aulton's Pharmaceutics written by Michael E. Aulton and published by Elsevier Health Sciences. This book was released on 2013 with total page 909 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Pharmaceutics is the art of pharmaceutical preparations. It encompasses design of drugs, their manufacture and the elimination of micro-organisms from the products. This book encompasses all of these areas."--Provided by publisher.

Pharmaceutical Manufacturing Handbook

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Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1386 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Pharmaceutical Practice E-Book

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Publisher : Elsevier Health Sciences
ISBN 13 : 0702041874
Total Pages : 663 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Pharmaceutical Practice E-Book by : Arthur J. Winfield

Download or read book Pharmaceutical Practice E-Book written by Arthur J. Winfield and published by Elsevier Health Sciences. This book was released on 2009-07-21 with total page 663 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book covers a wide range of subjects relevant to pharmacy practice, including communication skills, managing a business, quality assurance, dispensing, calculations, packaging, storage and labeling of medicines, sterilization, prescriptions, hospital-based services, techniques and treatments, adverse drug reactions, pharmacoeconomics, and medicines management. Features useful appendices on medical abbreviations, pharmaceutical Latin terms, weights and measures, and presentation skills. This is a core text for pharmacy practice and dispensing modules of the pharmacy curriculum Covers key exam material for essential review and test preparation Features a user-friendly design with clear headings, chapter summaries, helpful boxes, and key points Text restructured with 14 new or radically revised chapters. All text revised in light of current pharmaceutical practice. New design using two colours.

The Complete Holistic Dog Book

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Publisher : Celestial Arts
ISBN 13 : 030780948X
Total Pages : 385 pages
Book Rating : 4.3/5 (78 download)

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Book Synopsis The Complete Holistic Dog Book by : Jan Allegretti

Download or read book The Complete Holistic Dog Book written by Jan Allegretti and published by Celestial Arts. This book was released on 2013-10-15 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Naturally, you want the best for your canine companion's body, mind, and spirit. Ensure a lifetime of tail wags and dogged good health with THE COMPLETE HOLISTIC DOG BOOK. Animal healers Jan Allegretti and Katy Sommers discuss natural preventive health care, including early socialization, environmental safety, nutrition, and the application of alternative therapies and allopathic medicine. A thorough grounding in homeopathy, traditional Chinese medicine, and herbal remedies provides practical techniques for treating hundreds of common canine illnesses, injuries, and health problems. Also covering the special needs of older dogs, THE COMPLETE HOLISTIC DOG BOOK is a compassionate reference for animal guardians and caregivers, at home as well as in a clinical setting. Offers a unique, holistic approach that maintains the health of a dog's entire body system, from puppyhood through the senior years. With an easy-to-use, 80-page Materia Medica covering nutritional supplements, herbs, and homeopathic remedies. Includes a guide to creating a holistic first-aid kit. From the Trade Paperback edition.