Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

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Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena(®)). Samples o...

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Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate

From Wake Forest University, WinstonSalem, N.C. (P.J.M.); the National Institute of Child Health and Human Development, Bethesda, Md. (M.K., C.Y.S.); the Biostatistics Center, George Washington University, Rockville, Md. (E.T.); Wayne State University, Detroit (M.P.D.); the University of Tennessee, Memphis (B.S.); the University of Chicago, Chicago (A.H.M.); the University of Alabama, Birmingha...

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Source of 17-hydroxyprogesterone caproate in clinical trials.

TO THE EDITORS: Rozenberg and colleagues 1 reported that 17-hydroxyprogesterone caproate (17Pc) (500 mg twice/wk) did not significantly increase time to delivery or improve neo-natal outcome when used as maintenance therapy after an episode of preterm labor. We would ask the authors to disclose the source of the drug and to clarify whether there was any testing to assure its quality. This is cr...

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Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.

BACKGROUND Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of...

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ژورنال

عنوان ژورنال: Drug Development and Industrial Pharmacy

سال: 2012

ISSN: 0363-9045,1520-5762

DOI: 10.3109/03639045.2012.662511