Generic Drug Product Development
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Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2013-10-24
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-24 with Medical categories.
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
Generic Drug Product Development
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
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
Generic Drug Product Development
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Author : Leon Shargel
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Generic Drug Product Development written by Leon Shargel and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty dru
Chemical Engineering In The Pharmaceutical Industry
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Author : Mary T. am Ende
language : en
Publisher: John Wiley & Sons
Release Date : 2019-04-08
Chemical Engineering In The Pharmaceutical Industry written by Mary T. am Ende and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-08 with Technology & Engineering categories.
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
The Generic Challenge
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Author : Martin A. Voet
language : en
Publisher: BrownWalker Press
Release Date : 2020-05-01
The Generic Challenge written by Martin A. Voet and has been published by BrownWalker Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-01 with Law categories.
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
An Overview Of Fda Regulated Products
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Author : Eunjoo Pacifici
language : en
Publisher: Academic Press
Release Date : 2025-03-26
An Overview Of Fda Regulated Products written by Eunjoo Pacifici and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-03-26 with Medical categories.
An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Second Edition is fully updated to reflect recent advances in science and technology and new laws and regulations. Breakthroughs in cellular and gene therapy, immunotherapy, precision medicine, and digital health are changing the face of healthcare and regulation. The updates brought about by the 21st Century Cures Act and subsequent PDUFA Reauthorizations, as well as signing into law the "Modernization of Cosmetic Regulation Act of 2022," which will transform FDA's oversight of cosmetics, are fully reflected in all chapters of the book.This book provides graduate students and industry professionals with comprehensive information on approval processes with the FDA and other country regulation organizations. Regulatory science professionals working with not only drugs, but biologics, medical devices, food and additives, cosmetics, veterinary products, and tobacco will benefit from this comprehensive overview of the regulatory environment. - Provides an in-depth overview on how drugs, cosmetics, food, and tobacco products are regulated by the FDA and agencies around the world - Includes chapters that have been fully revised and updated - Covers the regulatory changes brought up by the 21st Century Cures Act and subsequent PDUFA Reauthorizations - Presents a new chapter on how to ensure medical product safety
Bringing Your Pharmaceutical Drug To Market
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Author : Neil P. DiSpirito
language : en
Publisher:
Release Date : 2016-10-13
Bringing Your Pharmaceutical Drug To Market written by Neil P. DiSpirito and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-13 with Law categories.
Micro And Nanotechnologies Based Product Development
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Author : Neelesh Kumar Mehra
language : en
Publisher: CRC Press
Release Date : 2021
Micro And Nanotechnologies Based Product Development written by Neelesh Kumar Mehra and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Medical categories.
This book provides comprehensive information of the nanotechnological based pharmaceutical product development including diverse range of arena liposome, nanoparticles, fullerenes, hydrogels.