The pharmaceutical regulatory process /
| Beste egile batzuk: | , |
|---|---|
| Formatua: | Liburua |
| Hizkuntza: | English |
| Argitaratua: |
New York :
Informa Healthcare,
c2008 [reprinted 2022].
|
| Saila: | Drugs and the pharmaceutical sciences ;
v. 185. |
| Gaiak: | |
| Classic Catalogue: | View this record in Classic Catalogue |
Aurkibidea:
- Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann
- Modernizing the Food And Drug Administration / Arthur Y. Tsien
- The new drug approval- process - before and after 1962 / Michael P. Peskoe
- Generic drug-approval process - Hatch-Waxman update / Marc S. Gross ... [et al.]
- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd
- FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen
- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.]
- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson
- Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley
- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin
- Drugs marketed without FDA approval / Jane Baluss and David Rosen
- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England.
- Active pharmaceutical ingredients / Max S. Lazar
- Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah
- Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber
- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead
- Current good manufacturing practice and the drug approval process / Ira R. Berry
- The influence of the USP on the drug approval process / Edward M. Cohen
- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo
- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta
- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour
- Living with 21 CFR part 11 compliance / Richard L. Burcham.