Screen LibraryPharmaceutical stability testing to support global markets
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| Corporate Authors: | |
|---|---|
| Group Author: | |
| Published: |
Springer,
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| Publisher Address: | New York |
| Publication Dates: | c2010. |
| Literature type: | Book |
| Language: | English |
| Series: |
Biotechnology: pharmaceutical aspects ; v. 12 |
| Subjects: | |
| Online Access: |
http://dx.doi.org/10.1007/978-1-4419-0889-6 |
| Carrier Form: | xix, 265 p.: ; 24 cm. |
| ISBN: |
9781441908896 (electronic bk.) 1441908897 (electronic bk.) |
| Index Number: | R969 |
| CLC: | R969.4-532 |
| Contents: |
Includes bibliographical references and index. Sect. I. 1. Introduction / Kim Huynh-Ba -- Sect. II. Stability studies in a global environment. 2. Regulatory perspectives on product stability / Gary Buehler and Kim Huynh-Ba -- 3. Curent international harmonization efforts / Justina A. Molzon -- 4. Update on the WHO stability guideline / Sabine Kopp -- 5. Development of a regional guideline for the Eastern Mediterranean Region / Abdel Aziz Saleh and Kim Huynh-Ba -- 6. The challenge of diverse climates: adequate stability testing conditions for India / Saranjit Singh ... [et al.] -- 7. Requirements for South East Asian markets / Lucky S. Slamet and Kim Huynh-Ba -- 8. The role of USP monographs in stability testing / Karen A. Russo -- 9. Regulatory requirements for stability testing of generics / Gary Buehler and Kim Huynh-Ba -- 10. Stability design for consumer healthcare products / Jeffrey T. Needels ... [et al.] -- 11. Challenges of drug/devices pharmaceutical products / Duu-Gong Wu -- 12. Practical challenges of stability testing of nutraceutical formulations / Jairaj (Jai) Mehta -- 13. Setting tolerances for instrument qualification / Horacio N. Pappa and Kim Huynh-Ba. Sect. III. Technical concepts for stability program. 14. The concept of quality-by-design / Mark A. Staples -- 15. Forced degradation and its relation to real time druct product stability / Steven W. Baertschi -- 16. Low level impurities in drug substances and drug products and the analytical challenges in identification and quantitation / Ganapathy Mohan -- 17. Stability of repackaged products / Mansoor A. Khan -- 18. Packaging-induced intractions and degradation / Mark D. Argentine and Patrick J. Jansen -- 19. An overview of physical stability of pharmaceuticals / Yushen Guo -- 20. Stability of split tablets / Vilayat A. Sayeed, Abhay Gupta, and Mansoor A. Khan -- 21. Temperature monitoring during shipment and storage / Conny Axelsson -- 22. Introducing a science-based quality by design concept to analytical methods development / Jianmei Koc Contains proceedings of the AAPS Stability Workshop. |