Pharmaceutical stability testing to support global markets
By: edited by Kim Huynh-Ba
Contributors: Huynh-Ba, Kim; American Association of Pharmaceutical Scientists
Series: Biotechnology: pharmaceutical aspects -- v. 12; Biotechnology: pharmaceutical aspects -- v. 12.
Publisher: Springer
Published: 2010
Place of publication: New York
Language: eng
Number of pages: 265
ISBN-13: 9781441908889; 9781441908896
Notes: Includes bibliographical references and index.
Table of contents: title: Sect. I. 1. Introduction / Kim Huynh-Ba; title: Sect. II. Stability studies in a global environment. 2. Regulatory perspectives on product stability / Gary Buehler and Kim Huynh-Ba; title: 3. Curent international harmonization efforts / Justina A. Molzon; title: 4. Update on the WHO stability guideline / Sabine Kopp; title: 5. Development of a regional guideline for the Eastern Mediterranean Region / Abdel Aziz Saleh and Kim Huynh-Ba; title: 6. The challenge of diverse climates: adequate stability testing conditions for India / Saranjit Singh ... [et al.]; title: 7. Requirements for South East Asian markets / Lucky S. Slamet and Kim Huynh-Ba; title: 8. The role of USP monographs in stability testing / Karen A. Russo; title: 9. Regulatory requirements for stability testing of generics / Gary Buehler and Kim Huynh-Ba; title: 10. Stability design for consumer healthcare products / Jeffrey T. Needels ... [et al.]; title: 11. Challenges of drug/devices pharmaceutical products / Duu-Gong Wu; title: 12. Practical challenges of stability testing of nutraceutical formulations / Jairaj (Jai) Mehta; title: 13. Setting tolerances for instrument qualification / Horacio N. Pappa and Kim Huynh-Ba.; title: Sect. III. Technical concepts for stability program. 14. The concept of quality-by-design / Mark A. Staples; title: 15. Forced degradation and its relation to real time druct product stability / Steven W. Baertschi; title: 16. Low level impurities in drug substances and drug products and the analytical challenges in identification and quantitation / Ganapathy Mohan; title: 17. Stability of repackaged products / Mansoor A. Khan; title: 18. Packaging-induced intractions and degradation / Mark D. Argentine and Patrick J. Jansen; title: 19. An overview of physical stability of pharmaceuticals / Yushen Guo; title: 20. Stability of split tablets / Vilayat A. Sayeed, Abhay Gupta, and Mansoor A. Khan; title: 21. Temperature monitoring during shipment and storage / Conny Axelsson; title: 22. Introducing a science-based quality by design concept to analytical methods development / Jianmei Kochling, Juma Bridgewater, and Redouan Naji.; title: Sect. IV. Stability data and operational practices. 23. Optimizing stability data package to facilitate NDA/MAA approval / Frank Diana; title: 24. Maximize data for post approval changes / Paula J. Youngberg Webb; title: 25. use of statistics to establish a stability trend: matrixing / earl Nordbrock; title: 26. Setting specifications for drug substances / Jon V. Beaman; title: 27. Setting specifications for drug products / Abbie Gentry; title: 28. Highlights of investigating out-of-specifications test results / Saji thomas and Kim Huynh-Ba; title: 29. Strategies for ensuring regulatory and cGMP compliance of outsourced stability programs / Eda Ross Montgomery; title: 30. Building and developing of relationships with third party laboratories / Rob Aitchison; title: 31. Outsourcing stability testing: a tool for resource and risk management / Michael D. Barron.