Pharmaceutical Technology-09-01-2012

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The authors describe a solid form technology platform used to optimize salt selection, cocrystallization identification and modification, or the development of a free form.

The authors explain chemical transformations that are achievable through certain biocatalytic routes.

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.