Preparing for FDA pre-approval inspections

Author(s)

• Hynes, Martin D.

Bibliographic Information

Preparing for FDA pre-approval inspections

edited by Martin D. Hynes, III

（Drugs and the pharmaceutical sciences, v. 93）

Marcel Dekker, c1999

Note

Includes bibliographical references and index

Description and Table of Contents

Description

This one-of-a-kind reference clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market.

Table of Contents

Introduction to the Food and Drug Administration Pre-New Drug Applications Approval Inspections o Developing a Strategic Approach to Preparing for a Successful Pre-NDA Approval Inspection o Food and Drug Administration International Pre-Approval Inspections o Stability Data and Pre-Approval Inspections o Consequences of Failing a Pre-Approval Inspection o Successful Management of a Pre-Approval Inspection o The Validation of Pharmaceutical Processes o Documentation Standards for Pre-Approval Inspections o Technology Transfer and Scale-up o Training of Personnel in the Pharmaceutical Industry o Compliance with Current Good Manufacturing Practices and Application Commitments

by "Nielsen BookData"

• NCID: BA46165807
• ISBN:
  • 0824702182
• LCCN: 98027750
• Country Code: us
• Title Language Code: eng
• Text Language Code: eng
• Place of Publication: New York
• Pages/Volumes: ix, 284 p.
• Size: 24 cm
• Classification:
  • LCC : RM301.27
  • DC21 : 615/.19
• Subject Headings:
  • LCSH : Drugs -- Research -- Standards -- United States
  • LCSH : United States. Food and Drug Administration
• Parent Bibliography ID:
  • BA03948165