Global Pharmaceutical And Biologics Regulation
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GLOBAL PHARMACEUTICAL AND BIOLOGICS REGULATORY STRATEGY
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2016 |
Genre | : Electronic Book |
ISBN | : 0996949151 |
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Global Pharmaceutical and Biologics Regulatory Strategy Second Edition
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2020-03-06 |
Genre | : Electronic Book |
ISBN | : 1947493418 |
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Global Pharmaceutical and Biologics Regulation
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2014-05-23 |
Genre | : Electronic Book |
ISBN | : 0989802884 |
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Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Global Pharmaceutical and Biologics Regulation
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2014-05-23 |
Genre | : Electronic Book |
ISBN | : 0989802868 |
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Compilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
Regulatory Affairs in the Pharmaceutical Industry
Author | : Javed Ali,Sanjula Baboota |
Publsiher | : Academic Press |
Total Pages | : 287 |
Release | : 2021-11-14 |
Genre | : Medical |
ISBN | : 9780128222232 |
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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
Fundamentals of International Pharmaceutical and Biologics Regulations
Author | : Zeeshaan Arshad,Nicole Beard,David Brindley,Orin Chisholm,Rosie Dawes,Elizabeth Goldstein,Ceine-Lea Halioua-Haubold,Nathalie Innocent,Colin Jacob,Jocelyn Jennings,Mona Koshkouei,Bernard Naughton,Megumi Nozawa,Terrance Ocheltree,Kathrin Schalper,William Sietsema,David Silberstein,James Smith,James Ware,Lin Wu |
Publsiher | : Unknown |
Total Pages | : 252 |
Release | : 2017 |
Genre | : Biologicals |
ISBN | : 0997769734 |
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Global Pediatric Development of Drugs Biologics and Medical Devices
Author | : Jocelyn Jennings,Linda McBride |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2021-11-26 |
Genre | : Electronic Book |
ISBN | : 1947493736 |
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Fundamentals of International Pharmaceutical and Biologics Regulations
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2018-09-04 |
Genre | : Electronic Book |
ISBN | : 1947493213 |
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