Preparing for FDA pre-approval inspections

著者

• Hynes, Martin D.

書誌事項

Preparing for FDA pre-approval inspections

edited by Martin D. Hynes, III

（Drugs and the pharmaceutical sciences, v. 93）

Marcel Dekker, c1999

注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

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

「Nielsen BookData」 より

詳細情報

• NII書誌ID(NCID): BA46165807
• ISBN:
  • 0824702182
• LCCN: 98027750
• 出版国コード: us
• タイトル言語コード: eng
• 本文言語コード: eng
• 出版地: New York
• ページ数/冊数: ix, 284 p.
• 大きさ: 24 cm
• 分類:
  • LCC : RM301.27
  • DC21 : 615/.19
• 件名:
  • LCSH : Drugs -- Research -- Standards -- United States
  • LCSH : United States. Food and Drug Administration
• 親書誌ID:
  • BA03948165