Approved Prescription Drug Products 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 Approved Prescription Drug Products PDF full book. Access full book title Approved Prescription Drug Products by . Download full books in PDF and EPUB format.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
Get Book Here
Book Description
Accompanied by supplements.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
Get Book Here
Book Description
Accompanied by supplements.
Author: Robin A. Cohen
Publisher:
ISBN:
Category : Drug utilization
Languages : en
Pages : 12
Get Book Here
Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Get Book Here
Book Description
Author: Shashank Upadhye
Publisher:
ISBN: 9780314991447
Category : Generic drugs
Languages : en
Pages : 643
Get Book Here
Book Description
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: Lawrence X. Yu
Publisher: Springer
ISBN: 1493912526
Category : Medical
Languages : en
Pages : 472
Get Book Here
Book Description
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
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: Katherine Eban
Publisher: HarperCollins
ISBN: 0063054108
Category : Medical
Languages : en
Pages : 523
Get Book Here
Book Description
A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a new postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 374
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
Get Book Here
Book Description
