Screen LibraryPharmaceutical stability testing to support global markets
Saved in:
| Corporate Authors: | ; |
|---|---|
| Group Author: | |
| Published: |
Springer,
|
| Publisher Address: | New York |
| Publication Dates: | c2010. |
| Literature type: | Book |
| Language: | English |
| Series: |
Biotechnology: pharmaceutical aspects ; v. 12 |
| Subjects: | |
| Carrier Form: | xix, 265 p.: ill. ; 27 cm. |
| ISBN: |
9781441908889 (hardback : alk. paper) 9781441908896 (e-book) 1441908897 (e-book) 1441908889 (hardback : alk. paper) |
| Index Number: | R969 |
| CLC: | R969.4-532 |
| Call Number: | R969.4-532/A112/2007 |
| Contents: |
Includes bibliographical references and index. Sect. IV. Stability data and operational practices. 23. Optimizing stability data package to facilitate NDA/MAA approval / Frank Diana -- 24. Maximize data for post approval changes / Paula J. Youngberg Webb -- 25. use of statistics to establish a stability trend: matrixing / earl Nordbrock -- 26. Setting specifications for drug substances / Jon V. Beaman -- 27. Setting specifications for drug products / Abbie Gentry -- 28. Highlights of investigating out-of-specifications test results / Saji thomas and Kim Huynh-Ba |