Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of JusticePublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 196
Book Description
Generic Animal Drug and Patent Term Restoration Act
Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of JusticePublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 196
Book Description
Generic drug entry prior to patent expiration an FTC study
Author: Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Book Description
FDA Approved Animal Drug Products
Author: Generic Animal Drugs
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the EnvironmentPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 180
Book Description
Rare Diseases and Orphan Products
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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.
Patent-term Extension and the Pharmaceutical Industry
Author: Animal Drug Amendments and Patent Term Restoration Act of 1986
Author: United States. Congress. Senate. Committee on Labor and Human ResourcesPublisher:
ISBN:
Category : Patent extensions
Languages : en
Pages : 80
Book Description
FDA Bioequivalence Standards
Author: Lawrence X. YuPublisher: Springer
ISBN: 1493912526
Category : Medical
Languages : en
Pages : 472
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.
Agriculture rural development, and related agencies appropriations for fiscal year 1991
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related AgenciesPublisher:
ISBN:
Category : United States
Languages : en
Pages : 804
Book Description
Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 1991: Commodity futures trading commission
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related AgenciesPublisher:
ISBN:
Category : United States
Languages : en
Pages : 806
Book Description