Browsing by Author "International Pharmaceutical Federation (FIP)"

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    Biowaiver monographs for immediate release solid oral dosage forms: Lamivudine
    (2011-01-01) S. Strauch; E. Jantratid; J. B. Dressman; H. E. Junginger; S. Kopp; K. K. Midha; V. P. Shah; S. Stavchansky; D. M. Barends; Goethe-Universitat Frankfurt am Main; Mahidol University; Naresuan University; Organisation Mondiale de la Sante; University of Saskatchewan; International Pharmaceutical Federation (FIP); University of Texas at Austin; National Institute of Public Health and the Environment
    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 lamivudine as the only active pharmaceutical ingredient were reviewed. The solubility and permeability data of lamivudine as well as its therapeutic index, its pharmacokinetic properties, data indicating excipient interactions, and reported BE/bioavailability (BA) studies were taken into consideration. Lamivudine is highly soluble, but its permeability characteristics are not well-defined. Reported BA values in adults ranged from 82% to 88%. Therefore, lamivudine is assigned to the biopharmaceutics classification system (BCS) class III, noting that its permeability characteristics are near the border of BCS class I. Lamivudine is not a narrow therapeutic index drug. Provided that (a) the test product contains only excipients present in lamivudine IR solid oral drug products approved in the International Conference on Harmonization or associated countries in usual amounts and (b) the test product as well as the comparator product fulfills the BCS dissolution criteria for very rapidly dissolving; a biowaiver can be recommended for new lamivudine multisource IR products and major post-approval changes of marketed drug products. © 2011 Wiley-Liss, Inc.
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    Biowaiver monographs for immediate release solid oral dosage forms: Mefloquine hydrochloride
    (2011-01-01) S. Strauch; E. Jantratid; J. B. Dressman; H. E. Junginger; S. Kopp; K. K. Midha; V. P. Shah; S. Stavchansky; D. M. Barends; Goethe-Universitat Frankfurt am Main; Naresuan University; Organisation Mondiale de la Sante; University of Saskatchewan; International Pharmaceutical Federation (FIP); University of Texas at Austin; National Institute of Public Health and the Environment; Mahidol University
    Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing mefloquine hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. The solubility and permeability data of mefloquine hydrochloride as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability studies were taken into consideration. Mefloquine hydrochloride is not a highly soluble API. Since no data on permeability are available, it cannot be classified according to the Biopharmaceutics Classification System with certainty. Additionally, several studies in the literature failed to demonstrate BE of existing products. For these reasons, the biowaiver cannot be justified for the approval of new multisource drug products containing mefloquine hydrochloride. However, scale-up and postapproval changes (HHS-FDA SUPAC) levels 1 and 2 and most EU type I variations may be approvable without in vivo BE, using the dissolution tests described in these regulatory documents. © 2010 Wiley-Liss, Inc.