COMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Doxycycline Hyclate
نویسندگان
چکیده
E. JANTRATID, S. STRAUCH, C. BECKER, J.B. DRESSMAN, G.L. AMIDON, H.E. JUNGINGER, S. KOPP, K.K. MIDHA, V.P. SHAH, S. STAVCHANSKY, D.M. BARENDS Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany Bayer Technology Services GmbH, Leverkusen, Germany College of Pharmacy, University of Michigan, Ann Arbor, Michigan Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand World Health Organization (WHO), Geneva, Switzerland University of Saskatchewan, Saskatoon, Saskatchewan, Canada International Pharmaceutical Federation (FIP), The Hague, the Netherlands Pharmaceutical Division, College of Pharmacy, University of Texas at Austin, Austin, Texas RIVM—National Institute for Public Health and the Environment, Bilthoven, the Netherlands
منابع مشابه
Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate.
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing doxycycline hyclate are reviewed. According to the Biopharmaceutics Classification System (BCS), doxycycline hyclate can be assigned to BCS Class I. No problems with BE of IR doxycycline formulations containing different ...
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