Preparing for FDA pre-approval inspections
Author(s)
Bibliographic Information
Preparing for FDA pre-approval inspections
（Drugs and the pharmaceutical sciences, v. 93）
Marcel Dekker, c1999
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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"