عنوان

Pharmaceutical pre-approval inspections :

شابک

0849391849 (hardcover : alk. paper)

شابک

9780849391842 (hardcover : alk. paper)

شماره

b521805

عنوان اصلي

Pharmaceutical pre-approval inspections :

نام عام مواد

[Book]

ساير اطلاعات عنواني

a guide to regulatory success /

نام نخستين پديدآور

edited by Martin D. Hynes III

وضعيت ويراست

2nd ed

محل نشرو پخش و غیره

New York :

نام ناشر، پخش کننده و غيره

Informa Healthcare,

تاریخ نشرو بخش و غیره

c2008

نام خاص و کميت اثر

x, 278 p. :

ساير جزييات

ill. ;

ابعاد

24 cm

عنوان فروست

Drugs and the pharmaceutical sciences ;

شاپا ي ISSN فروست

181

متن يادداشت

Rev. ed. of: Preparing for FDA pre-approval inspections. c1999

متن يادداشت

Includes bibliographical references and index

متن يادداشت

The evolution of the Food and Drug Administration: pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- Training requirements in product development: a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- The systems-based pre-approval inspection / Elizabeth M. Troll -- A cGMP risk assessment and management strategy: guidelines for the pre-approval inspection / Carmen Medina -- Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- Integral for successful PAI: the quality assessment program / Graham Bunn -- All dressed up but no approval to go: the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman

بدون عنوان

0

موضوع مستند نشده

United States.

موضوع مستند نشده

United States.

موضوع مستند نشده

Drugs-- Research-- Standards-- United States

موضوع مستند نشده

Drug Approval-- United States

موضوع مستند نشده

Laboratories-- standards-- United States

شماره

ويراست

شماره رده

نشانه اثر

شماره رده

شماره رده

نشانه اثر

نشانه اثر

مستند نام اشخاص تاييد نشده

Hynes, Martin D

تاريخ عمليات

20080709030207.0

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y