International Pharmaceutical Product Registration

Author : Anthony C. Cartwright,Brian R. Matthews
Publisher : CRC Press
Page : 804 pages
File Size : 41,8 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420081831

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International Pharmaceutical Product Registration by Anthony C. Cartwright,Brian R. Matthews Pdf

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou

Author : Anthony C. Cartwright
Publisher : Unknown
Page : 928 pages
File Size : 42,7 Mb
Release : 1994
Category : Electronic
ISBN : OCLC:932304947

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International pharmaceutical product registration by Anthony C. Cartwright Pdf

Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Page : 492 pages
File Size : 41,7 Mb
Release : 2013-03-05
Category : Medical
ISBN : 9781118516980

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Nonclinical Safety Assessment by William J. Brock,Kenneth L. Hastings,Kathy M. McGown Pdf

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Author : Alan A. Chalmers
Publisher : CRC Press
Page : 872 pages
File Size : 46,7 Mb
Release : 2000-06-01
Category : Medical
ISBN : 1574911031

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International Pharmaceutical Registration by Alan A. Chalmers Pdf

The increasing globalization of pharmaceutical markets and continuing consolidation within the pharmaceutical industry have highlighted the challenges of rapidly evolving regulatory requirements and created a much greater appreciation of the need for regulatory awareness throughout the industry. This book provides a practical overview and guide to the complexities of international pharmaceutical registration. With individual country chapters written by experts within that country drawn from regulatory authorities, international pharmaceutical companies, and regulatory consultants, the book comprehensively covers regulations across the globe.

Author : International Federation of Pharmaceutical Manufacturers Association
Publisher : Unknown
Page : 324 pages
File Size : 46,6 Mb
Release : 1975
Category : Drug registration
ISBN : RUTGERS:390300029511110

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Legal and Practical Requirements for the Registration of Drugs (medicinal Products) for Human Use by International Federation of Pharmaceutical Manufacturers Association Pdf

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 620 pages
File Size : 51,9 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440539

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Author : Suresh Pradhan
Publisher : Praeger
Page : 322 pages
File Size : 52,7 Mb
Release : 1983-08-26
Category : Business & Economics
ISBN : UOM:35128000870780

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International Pharmaceutical Marketing by Suresh Pradhan Pdf

International Pharmaceutical Marketing is an authoritative study of the world pharmaceutical industry from a marketing perspective. Dr. Pradhan, a respected expert in pharmaceutical economics, provides a broad-based discussion of the subject, including international marketing and organization, exporting, investing and licensing, product registration, patents, and new drug development. International pharmaceutical market research, product and pricing policy, promotional activities, and distribution systems are investigated and described in detail. Finally, the author focuses on the operations of the drug industry in twenty selected nations. Background, data, and analysis relevant to the unique characteristics of the industry provide the information necessary to analyze international marketing problems and formulate strategies and policies.

Author : Isadore Kanfer
Publisher : Taylor & Francis US
Page : 334 pages
File Size : 43,8 Mb
Release : 2010
Category : Bioavailability
ISBN : 1841847844

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Generic Drug Product Development: International Regulatory Requirements for Bioequivalence by Isadore Kanfer Pdf

Discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publisher : National Academies Press
Page : 169 pages
File Size : 53,9 Mb
Release : 2020-04-25
Category : Medical
ISBN : 9780309498630

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Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Pdf

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Author : Richard N. Spivey,Albert I. Wertheimer,T. Donald Rucker
Publisher : Psychology Press
Page : 686 pages
File Size : 55,5 Mb
Release : 1992
Category : Business & Economics
ISBN : 0866569065

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International Pharmaceutical Services by Richard N. Spivey,Albert I. Wertheimer,T. Donald Rucker Pdf

A comparative overview of the laws which govern pharmacy services in different countries, the organization of the medical community and health care delivery services, and the involvement of pharmacy practice within the health care delivery system. Annotation copyright Book News, Inc. Portland, Or.

Author : Javed Ali,Sanjula Baboota
Publisher : Academic Press
Page : 287 pages
File Size : 44,7 Mb
Release : 2021-11-14
Category : Medical
ISBN : 9780128222232

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Regulatory Affairs in the Pharmaceutical Industry by Javed Ali,Sanjula Baboota Pdf

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

Author : Isadore Kanfer,Leon Shargel
Publisher : CRC Press
Page : 334 pages
File Size : 41,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020021

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Generic Drug Product Development by Isadore Kanfer,Leon Shargel Pdf

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Page : 780 pages
File Size : 46,6 Mb
Release : 2007-04-30
Category : Medical
ISBN : 0470093145

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Principles and Practice of Pharmaceutical Medicine by Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier Pdf

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Author : John P. Griffin
Publisher : John Wiley & Sons
Page : 776 pages
File Size : 42,9 Mb
Release : 2009-10-15
Category : Business & Economics
ISBN : 1444317563

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The Textbook of Pharmaceutical Medicine by John P. Griffin Pdf

The Textbook of Pharmaceutical Medicine is a standardreference for all those working in pharmaceutical medicine and therecognised text for the UK Faculty of Pharmaceutical MedicineDiploma. This is a comprehensive volume covering the processes bywhich medicines are developed, tested and approved. Regulations fordrug development in the UK, EU, USA, Australia and Japan arediscussed, providing relevant information for drug approval in themain continents where new drugs are developed. The chapters are written by leading academics, medical directorsand lawyers, providing authoritative and in-depth information fortrainees on the Faculty course, and for physicians working in thepharmaceutical industry. As well as thorough updating of theregulatory chapters, the 6th edition includes chapters onthese vital new areas: Paediatric regulation Ethics Due diligence and the pharmaceutical physician

Author : Susan Walters (Dr),Organisation mondiale de la santé
Publisher : Unknown
Page : 142 pages
File Size : 49,8 Mb
Release : 2011
Category : Drugs
ISBN : 9241501456

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Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (generic) Products by Susan Walters (Dr),Organisation mondiale de la santé Pdf