Generic Drug Product Development PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Generic Drug Product Development PDF full book. Access full book title Generic Drug Product Development by Leon Shargel. Download full books in PDF and EPUB format.
Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086367
Category : Medical
Languages : en
Pages : 384
Get Book Here
Book Description
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
Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086367
Category : Medical
Languages : en
Pages : 384
Get Book Here
Book Description
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
Author: Isadore Kanfer
Publisher: CRC Press
ISBN: 1420020021
Category : Medical
Languages : en
Pages : 334
Get Book Here
Book Description
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: Sandeep Narayan Patil, PMP
Publisher: Notion Press
ISBN: 1638067554
Category : Medical
Languages : en
Pages : 281
Get Book Here
Book Description
This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Get Book Here
Book Description
Author: Vandana B. Patravale
Publisher: CRC Press
ISBN: 1498730787
Category : Medical
Languages : en
Pages : 438
Get Book Here
Book Description
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Get Book Here
Book Description
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.
Author: Robin A. Cohen
Publisher:
ISBN:
Category : Drug utilization
Languages : en
Pages : 12
Get Book Here
Book Description
Author: Martin A. Voet
Publisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240
Get Book Here
Book Description
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.
Author: Neil P. DiSpirito
Publisher:
ISBN: 9781935065753
Category : Law
Languages : en
Pages : 804
Get Book Here
Book Description
Author: Isadore Kanfer
Publisher: CRC Press
ISBN:
Category : Business & Economics
Languages : en
Pages : 292
Get Book Here
Book Description
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
