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Book Summary
About the Book: Compliance Handbook For Pharmaceuticals, Medical Devices, And
Biologics, Vol. 136
Lists the necessary steps for meeting compliance requirements during the drug
development process. Presents comprehensive approaches for validating analytical
methods for pharmaceutical applications. Features key discussions on
pre-approval inspections.
Contents
Regulatory submissions, Patricia Fritz and Anisa Dhalla; compliance requirements
during the drug development process, Martin D. Hynes; validation - a new
perspective, James Agalloco; validating analytical methods for pharmaceutical
applications - a comprehensive approach, Paul A. Winslow and Richard F. Meyer;
the stability testing programme, Maria Geigel; computer validation - a
compliance focus, Timothy Horgan and Timothy Carey; compliance issues associated
with cleaning in the pharmaceutical industry, William E.
- ISBN-13
- 9780824740788
- Language
- English
- Binding
- Hard Bound
- Publisher
- Taylor and Francis
- Publishing Date
- 2003-12-09
- Total Pages
- 704
Compliance Handbook For Pharmaceuticals, Medical Devices, And Biologics, Vol. 136
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Product Specifications
Book Summary
About the Book: Compliance Handbook For Pharmaceuticals, Medical Devices, And
Biologics, Vol. 136
Lists the necessary steps for meeting compliance requirements during the drug
development process. Presents comprehensive approaches for validating analytical
methods for pharmaceutical applications. Features key discussions on
pre-approval inspections.
Contents
Regulatory submissions, Patricia Fritz and Anisa Dhalla; compliance requirements
during the drug development process, Martin D. Hynes; validation - a new
perspective, James Agalloco; validating analytical methods for pharmaceutical
applications - a comprehensive approach, Paul A. Winslow and Richard F. Meyer;
the stability testing programme, Maria Geigel; computer validation - a
compliance focus, Timothy Horgan and Timothy Carey; compliance issues associated
with cleaning in the pharmaceutical industry, William E.
Book Specifications
- ISBN-13
- 9780824740788
- Language
- English
- Binding
- Hard Bound
- Publisher
- Taylor and Francis
- Publishing Date
- 2003-12-09
- Total Pages
- 704