Process Development Challenges To Accommodate A Late-Appearing Stable Polymorph: A Case Study On The Polymorphism And Crystallization Of A Fast-Track Drug Development Compound
ORGANIC PROCESS RESEARCH & DEVELOPMENT(2005)
摘要
The case of disappearing/late-appearing stable polymorphs and their impact is well-understood by scientists in the pharmaceutical industry. This paper discusses an instance where a more stable crystal form was discovered during the development of a fast-track drug candidate. Challenges in adapting to the discovery of the new crystal form during this accelerated drug development program and approaches to develop a robust crystallization process are discussed.
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关键词
drug development,polymorphism,process development
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