Preparing for FDA Pre-Approval Inspections (Drugs & the Pharmaceutical Sciences) (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs)

Preparing for FDA Pre-Approval Inspections (Drugs & the Pharmaceutical Sciences) (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs)
Product Details
Hardcover: 284 pages
Publisher: Marcel Dekker (October 1, 1998)
Language: English
ISBN: 0824702182
Product Dimensions: 9.0 x 6.0 x 0.8 inches
Shipping Weight: 2.7 pounds.
Editorial Reviews
From Book News, Inc.
Clarifies the US Food and Drug Administration's requirements for the manufacture of drugs for clinical trials, and suggests strategies for facilitating its authorization to market them in the context of product development activities. Identifies key inspection areas such as stability, validation, training, scale-up, and technology transfer. Describes short-term and long-term strategies that companies use successfully to prepare for pre-approval inspections, methods for managing the inspection process, ways to minimize observations and the number of inspections, the consequences of failing the inspection, how to respond to the agency's comments, and other aspects. Of interest to both technical and non-technical professionals in the pharmaceutical industry. Book News, Inc.?, Portland, OR