Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles by Patricia Van Arnum

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The physical form of an API is an important consideration in formulation development. Particle-engineering technologies, such as crystal design for controlling crystallisation and producing cocrystals, particle-size reduction and amorphous solid dispersions, help to optimise delivery of a drug.

The Generic Drug User Fee Act seeks to improve and enhance regulatory activities, including achieving parity of inspections between foreign and domestic drug-manufacturing sites for both finished dosage forms and APIs of generic drugs.

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.

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.