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The FDA Should Eliminate the Ambiguities in the Current BCS Biowaiver Guidance and Make Public the Drugs for Which BCS Biowaivers Have Been GrantedBENET, L. Z; LARREGIEU, C. A.Clinical pharmacology and therapeutics. 2010, Vol 88, Num 3, pp 405-407, issn 0009-9236, 3 p.Article

Risk analysis in bioequivalence and biowaiver decisions : Relationships Between In Vitro Dissolution and In Vivo Response: Part IIKUBBINGA, Marlies; LANGGUTH, Peter; BARENDS, Dirk et al.Biopharmaceutics & drug disposition. 2013, Vol 34, Num 5, pp 254-261, issn 0142-2782, 8 p.Article

Level a in vitro-in vivo correlation (IVIVC) model with bayesian approach to formulation seriesKORTEJÄRVI, H; MALKKI, J; MARVOLA, M et al.Journal of pharmaceutical sciences. 2006, Vol 95, Num 7, pp 1595-1605, issn 0022-3549, 11 p.Article

Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe : Relationships Between In Vitro Dissolution and In Vivo Response: Part IILIMBERG, Jobst; POTTHAST, Henrike.Biopharmaceutics & drug disposition. 2013, Vol 34, Num 5, pp 247-253, issn 0142-2782, 7 p.Article

Suitability of Isolated Rat Jejunum Model for Demonstration of Complete Absorption in Humans for BCS-Based Biowaiver RequestPETERNEL, Luka; KRISTAN, Katja; PETRUSEVSKA, Marija et al.Journal of pharmaceutical sciences. 2012, Vol 101, Num 4, pp 1436-1449, issn 0022-3549, 14 p.Article

Review of global regulations concerning biowaivers for immediate release solid oral dosage formsGUPTA, E; BARENDS, D. M; YAMASHITA, E et al.European journal of pharmaceutical sciences. 2006, Vol 29, Num 3-4, pp 315-324, issn 0928-0987, 10 p.Conference Paper

Regulatory aspects of drug dissolution from a European perspectiveGRAFFNER, Christina.European journal of pharmaceutical sciences. 2006, Vol 29, Num 3-4, pp 288-293, issn 0928-0987, 6 p.Conference Paper

Biowaiver Approach for Biopharmaceutics Classification System Class 3 Compound Metformin Hydrochloride Using In Silico ModelingCRISON, John R; TIMMINS, Peter; KEUNG, Anther et al.Journal of pharmaceutical sciences. 2012, Vol 101, Num 5, pp 1773-1782, issn 0022-3549, 10 p.Article

Biowaiver monographs for immediate release solid oral dosage forms : IsoniazidBECKER, C; DRESSMAN, J. B; AMIDON, G. L et al.Journal of pharmaceutical sciences. 2007, Vol 96, Num 3, pp 522-531, issn 0022-3549, 10 p.Article

Pharmacokinetic simulation of biowaiver criteria : The effects of gastric emptying, dissolution, absorption and elimination ratesKORTEJÄRVI, H; URTTI, A; YLIPERTTULA, M et al.European journal of pharmaceutical sciences. 2007, Vol 30, Num 2, pp 155-166, issn 0928-0987, 12 p.Article

The Biowaiver Procedure: Its Application to Antituberculosis Products in the WHO Prequalification ProgrammeSTRAUCH, Stefanie; JANTRATID, Ekarat; STAHL, Matthias et al.Journal of pharmaceutical sciences. 2011, Vol 100, Num 3, pp 822-830, issn 0022-3549, 9 p.Article

Justification of metformin hydrochloride biowaiver criteria based on bioequivalence studyHOMSEK, Irena; PAROJCIC, Jelena; DACEVIC, Mirjana et al.Arzneimittel-Forschung. 2010, Vol 60, Num 9, pp 553-559, issn 0004-4172, 7 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms : Ethambutol DihydrochlorideBECKER, C; DRESSMAN, J. B; AMIDON, G. L et al.Journal of pharmaceutical sciences. 2008, Vol 97, Num 4, pp 1350-1360, issn 0022-3549, 11 p.Article

Biowaiver monographs for immediate release solid oral dosage forms : PrednisoneVOCT, M; DERENDORF, H; KRAMER, J et al.Journal of pharmaceutical sciences. 2007, Vol 96, Num 6, pp 1480-1489, issn 0022-3549, 10 p.Article

Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products cimetidineJANTRATID, Ekarat; PRAKONGPAN, Sompol; AMIDON, Gordon L et al.Clinical pharmacokinetics. 2006, Vol 45, Num 4, pp 385-399, issn 0312-5963, 15 p.Article

Investigation on the Possibility of Biowaivers for IbuprofenALVAREZ, Covadonga; NUNEZ, Ignacio; TORRADO, Juan J et al.Journal of pharmaceutical sciences. 2011, Vol 100, Num 6, pp 2343-2349, issn 0022-3549, 7 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Quinidine SulfateGRUBE, S; LANGGUTH, P; JUNGINGER, H. E et al.Journal of pharmaceutical sciences. 2009, Vol 98, Num 7, pp 2238-2251, issn 0022-3549, 14 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms : AciclovirARNAL, J; GONZALEZ-ALVAREZ, I; BARENDS, D. M et al.Journal of pharmaceutical sciences. 2008, Vol 97, Num 12, pp 5061-5073, issn 0022-3549, 13 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: FurosemideGRANERO, G. E; LONGHI, M. R; MORA, M. J et al.Journal of pharmaceutical sciences. 2010, Vol 99, Num 6, pp 2544-2556, issn 0022-3549, 13 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: RifampicinBECKER, C; DRESSMAN, J. B; JUNGINGER, H. E et al.Journal of pharmaceutical sciences. 2009, Vol 98, Num 7, pp 2252-2267, issn 0022-3549, 16 p.Article

Computer simulations using GastroPlus™ to justify a biowaiver for etoricoxib solid oral drug productsOKUMU, Arthur; DIMASO, Marie; LÖBENBERG, Raimar et al.European journal of pharmaceutics and biopharmaceutics. 2009, Vol 72, Num 1, pp 91-98, issn 0939-6411, 8 p.Article

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine SulfateSTRAUCH, Stefanie; DRESSMAN, Jennifer B; SHAH, Vinod P et al.Journal of pharmaceutical sciences. 2012, Vol 101, Num 2, pp 499-508, issn 0022-3549, 10 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amodiaquine HydrochlorideNAIR, Anita; ABRAHAMSSON, Bertil; BARENDS, Dirk M et al.Journal of pharmaceutical sciences. 2012, Vol 101, Num 12, pp 4390-4401, issn 0022-3549, 12 p.Article

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: LevofloxacinKOEPPE, Marcelle O; CRISTOFOLETTI, Rodrigo; BARENDS, Dirk M et al.Journal of pharmaceutical sciences. 2011, Vol 100, Num 5, pp 1628-1636, issn 0022-3549, 9 p.Article

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Primaquine PhosphateNAIR, Anita; ABRAHAMSSON, Bertil; BARENDS, Dirk M et al.Journal of pharmaceutical sciences. 2012, Vol 101, Num 3, pp 936-945, issn 0022-3549, 10 p.Article

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