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The use of BDDCS in...
The use of BDDCS in classifying the permeability of marketed drugs
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Benet, Leslie Z. (author)
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Amidon, Gordon L. (author)
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Barends, Dirk M. (author)
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- Lennernäs, Hans (author)
- Uppsala universitet,Institutionen för farmaci
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Polli, James E. (author)
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Shah, Vinod P. (author)
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Stavchansky, Salomon A. (author)
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Yu, Lawrence X. (author)
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(creator_code:org_t)
- 2008-01-31
- 2008
- English.
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In: Pharmaceutical research. - : Springer. - 0724-8741 .- 1573-904X. ; 25:3, s. 483-488
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https://europepmc.or...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- We recommend that regulatory agencies add the extent of drug metabolism (i.e., >or=90% metabolized) as an alternate method in defining Class 1 marketed drugs suitable for a waiver of in vivo studies of bioequivalence. That is, >or=90% metabolized is an additional methodology that may be substituted for >or=90% absorbed. We propose that the following criteria be used to define>or=90% metabolized for marketed drugs: Following a single oral dose to humans, administered at the highest dose strength, mass balance of the Phase 1 oxidative and Phase 2 conjugative drug metabolites in the urine and feces, measured either as unlabeled, radioactive labeled or nonradioactive labeled substances, account for >or=90% of the drug dosed. This is the strictest definition for a waiver based on metabolism. For an orally administered drug to be >or=90% metabolized by Phase 1 oxidative and Phase 2 conjugative processes, it is obvious that the drug must be absorbed. This proposal, which strictly conforms to the present>or=90% criteria, is a suggested modification to facilitate a number of marketed drugs being appropriately assigned to Class 1.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
Keyword
- BCS
- BDDCS
- bioequivalence
- elimination pathways
- PHARMACY
- FARMACI
Publication and Content Type
- ref (subject category)
- art (subject category)
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