Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Ira R. Berry"'
Autor:
Ira R Berry
Publikováno v:
Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition ISBN: 9781841848204
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::54d15fef33c5e071b268b483e7df9664
https://doi.org/10.1081/e-ept4-120050365
https://doi.org/10.1081/e-ept4-120050365
Autor:
Ira R Berry
Publikováno v:
Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition ISBN: 9781841848204
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::23f96d0d68b449f0026244fa63c7bb8a
https://doi.org/10.1081/e-ept4-120050283
https://doi.org/10.1081/e-ept4-120050283
Autor:
Ira R. Berry
Publikováno v:
The Pharmaceutical Regulatory Process ISBN: 9780429187209
INTRODUCTION Employment of∗ current good manufacturing practice (CGMP) and approval of a new drug application (NDA) are two pillars of federal law providing support of manufacturing quality for pharmaceutical drug products offered to American consu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3429877e17b7ba567ae5873636cbdeb7
https://doi.org/10.3109/9781420070439-20
https://doi.org/10.3109/9781420070439-20
Autor:
Ira R. Berry
Publikováno v:
The Pharmaceutical Regulatory Process
Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. New Drug Approval Process: Before and After 1962. FDA Regulation of Biological Products. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs. Generic Dr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f36505787dfab2cc7eaaf9d3e4af2f55
https://doi.org/10.1201/9780203997048
https://doi.org/10.1201/9780203997048
Autor:
Ira R. Berry, Robert P. Martin
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory
Autor:
Ira R. Berry
Publikováno v:
Drug Development and Industrial Pharmacy. 14:377-389
“Process Validation: Practical Applications to Pharmaceutical Products” by Ira R. Berry, Vice President-Technical Services, Pharmacaps, Inc., Elizabeth, NJ, USA.Process validation and control of pharmaceutical products has been discussed in many
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::74c87c10303c54e76c9be229bb14db99
https://doi.org/10.3109/03639048809151976
https://doi.org/10.3109/03639048809151976
