TY  - BOOK
AU  - Hynes,Martin D.
TI  - Preparing for FDA pre-approval inspections
T2  - Drugs and the pharmaceutical sciences
SN  - 0824702182 (alk. paper)
AV  - RM301.27 .P74 1999
U1  - 615.19 22
PY  - 1999///]
CY  - New York
PB  - Marcel Dekker Inc.
KW  - United States
KW  - Food and Drug Administration
KW  - Drugs
KW  - Research
KW  - Standards
N1  - 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

UR  - http://www.loc.gov/catdir/enhancements/fy0647/98027750-d.html
ER  -