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Development and validation of analytical methods /
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst i...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Tarrytown, N.Y. :
Pergamon,
1996.
|
| Edición: | 1st ed. |
| Colección: | Progress in pharmaceutical and biomedical analysis ;
v. 3. |
| Temas: | |
| Acceso en línea: | Texto completo Texto completo Texto completo |
Tabla de Contenidos:
- Section headings and papers: List of Contributors. Introduction. Basic Concepts. Assay validation and inter-laboratory transfer (E. McGonigle). Statistical parameters and analytical figures of merit (C.M. Riley). Regulatory Considerations. Overview of worldwide regulations (I.E. Davidson). Issues related to United States v. Barr Laboratories Inc. (C.L. Burgess). Judge Wolin's interpretations of current good manufacturing practice issues contained in the court's ruling in the United States v. Barr Laboratories (R.J. Davis). Specific Methods and Applications. Bulk drug substances and finished products (P.K. Hovsepian). Dissolution studies (T.W. Rosanske, C.K. Brown). Robotics and automated workstations (J.J. Tomlinson). Biotechnology products (G.S. Srivatsa). Biological samples (K.A. Selinger). Analytical methods for cleaning procedures (T.M. Rossi, R.R. Ryall). Computer systems and computer-aided validation (J.G. Liscouski). Index.