Titlebook: Handbook of Stability Testing in Pharmaceutical Development; Regulations, Methodo Kim Huynh-Ba Book 2009 Springer-Verlag New York 2009 Deve

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Jack B. Davisincreasingly sensitive space observatories and the significant advances in numerical astrophysics and cosmology....The current generations of large spectroscopic and wide-field imaging survey and ongoing multi-wavelength studies, covering a large range of the electromagnetic spectrum from X-rays to

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etection of clusters using different observational technique.The study of clusters of galaxies has advanced tremendously in the recent years due to the advent of large or dedicated ground-based telescopes, the increasingly sensitive space observatories and the significant advances in numerical astro

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Critical Regulatory Requirements for a Stability Programes that support the entire drug development phases. It also discusses the purpose that one wants to achieve with the data set that these studies generate..This chapter also discusses stability issues within the framework of the FDA cGMP guidelines as expressed in 21CFR Part 211. This review of cGMP

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Global Stability Practicess well as a discussion on how the climatic requirements are implied in the world. This comprehensive chapter gives an introduction of stability requirements for countries around the world. Discussions of World Health Organization (WHO) stability guidelines and Association of Southeast Asian Nations

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Post-approval Changes – Stability Requirements and Regulationssignificant and require a substantial amount of stability data while others are minor and may only require a stability commitment. Company change control procedures should detail how changes are evaluated and implemented as well as how the change impacts stability and what data will be needed to sup

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Understanding and Predicting Pharmaceutical Product Shelf-Liferage condition. A number of factors are used to assign that shelf-life. Among these factors are the chemical stability of the active pharmaceutical ingredient (API) in its dosage form, and specifically whether any degradation products are potentially hazardous to a patient. In addition, any factors

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