The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...

Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...

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A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010. A new guideline 1 for conducting bioequivalence studies was ...

Idarubicin cardiotoxicity: a retrospective study in acute myeloid leukemia and myelodysplasia. Initial phase I evaluation of the novel thymidylate synthase inhibitor, LY231514, using the modified ...

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A leading journal in its field for more than three quarters of a century, the Bulletin spans the social, cultural, and scientific aspects of the history of medicine worldwide. Every issue includes ...

Topical pharmaceutical products usually take the form of lotions, creams, gels, ointments, or pastes and are used to deliver locally-acting drugs to their sites of action. Local anesthetics, ...

See related research article by Tsadok and colleagues at www.cmaj.ca/lookup/doi/10.1503/cmaj.101800 and synopsis on page 1371; see also practice article by Mackenzie ...

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant ...