Regulatory Considerations

JB Schwartz - PDA Journal of Pharmaceutical Science and …, 1993 - journal.pda.org
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The importance of a regulatory science approach for better pharmaceutical regulation

Y UYama - Translational and Regulatory Sciences, 2019 - jstage.jst.go.jp
Although regulatory science has been recognized as an important field in the area of
pharmaceutical regulation, it may be still immature and is likely to evolve further as science …

[BOOK][B] Drugs Between Research and Regulations: Proceedings of the 5th International Meeting of Pharmaceutical Physicians Munich, October 14–17, 1984

C Steichele, U Abshagen, J Koch-Weser - 2013 - books.google.com
Franz Gross died suddenly during preparations for the meeting. He would have taken great
pleasure in summarizing in this preface the aims and results of a gathering which so clearly …

Regulatory science

M Uchiyama - PDA Journal of Pharmaceutical Science and …, 1995 - journal.pda.org
The mission of regulation is to provide the general population with the most desirable
products from among the many new ones currently available. Scientific activities supporting …

good regulatory practice (GRP)

G Nahler, G Nahler - Dictionary of Pharmaceutical Medicine, 2009 - Springer
good clinical research practice (GCRP) syn. good clinical prac- tice; term used in UK. good
clinical trial practice (GCTP) syn. Page 1 82 goo good clinical research practice (GCRP) syn …

[CITATION][C] The Regulatory Process

JC Somberg - The Journal of Clinical Pharmacology, 1986 - Wiley Online Library
COLOGY contains the first article in a series on the regulatory process of nations around the
world. Dr. Atul Laddu has been most helpful in organizing this series, which will aim at …

Three decades of drug regulation and legislation

J Wechsler - Pharmaceutical Technology, 2007 - go.gale.com
The US Food and Drug Administration has pursued many new initiatives since 1977. The
agency began accepting abbreviated applications for generic versions of drugs collected …

Drug Regulatory Affairs

PH Roberts - The Clinical Research Process in the …, 2020 - taylorfrancis.com
The regulations issued by the US Food and Drug Administration (FDA) several years later as
a means to implement the substantial changes in the act were written in a style considered …

Response to Presentation by Dr. MNG Dukes and Dr. Inga Lunde on the Effects of Regulation

WM Wardell - Drug Development, Regulatory Assessment, and …, 1981 - Springer
RESPONSE TO PRESENTATION BY DR. MNG DUKES AND DR. INGA LUNDE ON THE
EFFECTS OF REGULATION William M. WardeIl, MD, Ph.D. Cen Page 1 162 CHAPTER 7 …

Guest editor's note: Regulatory affairs

TL Copmann - Therapeutic Innovation & Regulatory Science, 2002 - search.proquest.com
CHANGE IS A GOOD thing. What would life be without change? Perhaps that is why I have
made a career of regulatory affairs. In the comer of my bookcase sits my first New Drug …