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Preparing for FDA pre-approval inspections / edited by Martin D. Hynes, III. - ix, 284 pages : illustrations ; 24 cm - Drugs and the pharmaceutical sciences ; v. 93 . - Drugs and the pharmaceutical sciences .

Includes bibliographical references and index.

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


ISBN: 0824702182 (alk. paper)

LCCN: 98027750

Subjects--Corporate Names:
United States. Food and Drug Administration.

Subjects--Topical Terms:
Drugs--Research--Standards--United States.

LC Class. No.: RM301.27 / .P74 1999

Dewey Class. No.: 615.19 / P.