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There are 12634 results for: content related to: Consistency in the safety labeling of bioequivalent medications

  1. Population and Individual Bioequivalence

    Bioequivalence Studies in Drug Development: Methods and Applications

    Dieter Hauschke, Volker Steinijans, Iris Pigeot, Pages: 205–282, 2007

    Published Online : 11 MAY 2007, DOI: 10.1002/9780470094778.ch9

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    Generic products of antiepileptic drugs: A perspective on bioequivalence and interchangeability

    Epilepsia

    Volume 51, Issue 6, June 2010, Pages: 941–950, Meir Bialer and Kamal K. Midha

    Version of Record online : 8 APR 2010, DOI: 10.1111/j.1528-1167.2010.02573.x

  3. Review of the 1993 Veterinary Drug Bioequivalence Workshop

    Journal of Veterinary Pharmacology and Therapeutics

    Volume 17, Issue 2, April 1994, Pages: 85–119, M. N. MARTINEZ and J. E. RIVIERE

    Version of Record online : 17 APR 2008, DOI: 10.1111/j.1365-2885.1994.tb00220.x

  4. On population and individual bioequivalence

    Statistics in Medicine

    Volume 12, Issue 12, June 1993, Pages: 1109–1124, Robert Schall and Herman G. Luus

    Version of Record online : 14 MAR 2007, DOI: 10.1002/sim.4780121202

  5. An individual bioequivalence criterion: regulatory considerations

    Statistics in Medicine

    Volume 19, Issue 20, 30 October 2000, Pages: 2821–2842, Mei-Ling Chen, Rabindra Patnaik, Walter W. Hauck, Donald J. Schuirmann, Terry Hyslop and Roger Williams

    Version of Record online : 6 OCT 2000, DOI: 10.1002/1097-0258(20001030)19:20<2821::AID-SIM548>3.0.CO;2-L

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    Generic Products of Antiepileptic Drugs (AEDs): Is It an Issue?

    Epilepsia

    Volume 48, Issue 10, October 2007, Pages: 1825–1832, Meir Bialer

    Version of Record online : 10 SEP 2007, DOI: 10.1111/j.1528-1167.2007.01272.x

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    Current challenges facing the determination of product bioequivalence in veterinary medicine

    Journal of Veterinary Pharmacology and Therapeutics

    Volume 33, Issue 5, October 2010, Pages: 418–433, M. N. MARTINEZ and R. P. HUNTER

    Version of Record online : 18 JUN 2010, DOI: 10.1111/j.1365-2885.2010.01180.x

  8. A THREE-STEP PROCEDURE FOR ASSESSING BIOEQUIVALENCE IN THE GENERAL MIXED MODEL FRAMEWORK

    Statistics in Medicine

    Volume 15, Issue 24, 30 December 1996, Pages: 2635–2655, JOUNI VUORINEN and JARI TURUNEN

    Version of Record online : 4 DEC 1998, DOI: 10.1002/(SICI)1097-0258(19961230)15:24<2635::AID-SIM444>3.0.CO;2-X

  9. Assessing individual bioequivalence using the structural equation model

    Statistics in Medicine

    Volume 22, Issue 6, 30 March 2003, Pages: 901–912, Josep-Lluís Carrasco and Lluís Jover

    Version of Record online : 21 FEB 2003, DOI: 10.1002/sim.1452

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    Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using In Silico modeling

    Journal of Pharmaceutical Sciences

    Volume 101, Issue 5, May 2012, Pages: 1773–1782, John R. Crison, Peter Timmins, Anther Keung, Vijay V. Upreti, David W. Boulton and Barry J. Scheer

    Version of Record online : 14 FEB 2012, DOI: 10.1002/jps.23063

  11. Pharmacokinetics and pharmacodynamics of stereoisomeric drugs with particular reference to bioequivalence determination

    Journal of Veterinary Pharmacology and Therapeutics

    Volume 35, Issue s1, April 2012, Pages: 17–29, P. LEES, R. P. HUNTER, P. T. REEVES and P. L. TOUTAIN

    Version of Record online : 13 MAR 2012, DOI: 10.1111/j.1365-2885.2012.01367.x

  12. Bioequivalence Studies

    Comparative Pharmacokinetics: Principles, Techniques, and Applications, Second Edition

    Jim E. Riviere, Pages: 315–346, 2011

    Published Online : 11 FEB 2011, DOI: 10.1002/9780470959916.ch15

  13. Kullback–Leibler divergence for evaluating bioequivalence

    Statistics in Medicine

    Volume 22, Issue 6, 30 March 2003, Pages: 913–930, Vladimir Dragalin, Valerii Fedorov, Scott Patterson and Byron Jones

    Version of Record online : 21 FEB 2003, DOI: 10.1002/sim.1451

  14. Bioequivalence: How, Why, and What Does it Really Mean?

    Journal of Pharmacy Practice and Research

    Volume 34, Issue 3, September 2004, Pages: 195–200, Gregory A Pearce, Andrew J McLachlan and Iqbal Ramzan

    Version of Record online : 1 SEP 2004, DOI: 10.1002/jppr2004343195

  15. A practical approach for evaluating population and individual bioequivalence

    Statistics in Medicine

    Volume 19, Issue 20, 30 October 2000, Pages: 2721–2740, A. Lawrence Gould

    Version of Record online : 6 OCT 2000, DOI: 10.1002/1097-0258(20001030)19:20<2721::AID-SIM541>3.0.CO;2-8

  16. Individual bioequivalence: What matters to the patient

    Statistics in Medicine

    Volume 10, Issue 6, June 1991, Pages: 959–960, Walter W. Hauck and Sharonerson Anderson

    Version of Record online : 12 OCT 2006, DOI: 10.1002/sim.4780100616

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    Effect of Truncating AUC at 12, 24 and 48 hr When Evaluating the Bioequivalence of Drugs with a Long Half-Life

    Basic & Clinical Pharmacology & Toxicology

    Volume 118, Issue 1, January 2016, Pages: 53–57, Isabel Moreno, Dolores Ochoa, Manuel Román, Teresa Cabaleiro and Francisco Abad-Santos

    Version of Record online : 14 JUL 2015, DOI: 10.1111/bcpt.12432

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    The biowaiver procedure: Its application to antituberculosis products in the WHO prequalification programme

    Journal of Pharmaceutical Sciences

    Volume 100, Issue 3, March 2011, Pages: 822–830, Stefanie Strauch, Ekarat Jantratid, Matthias Stahl, Lembit Rägo and Jennifer B. Dressman

    Version of Record online : 6 OCT 2010, DOI: 10.1002/jps.22349

  19. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fluconazole

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 12, December 2014, Pages: 3843–3858, Naseem Charoo, Rodrigo Cristofoletti, Alexandra Graham, Paul Lartey, Bertil Abrahamsson, D. W. Groot, Sabine Kopp, Peter Langguth, James Polli, Vinod P. Shah and Jennifer Dressman

    Version of Record online : 13 OCT 2014, DOI: 10.1002/jps.24181

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    Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 2, February 2014, Pages: 378–391, Naseem A. Charoo, Areeg A. A. Shamsher, Lai Y. Lian, Bertil Abrahamsson, Rodrigo Cristofoletti, D. W. Groot, Sabine Kopp, Peter Langguth, James Polli, Vinod P. Shah and Jennifer Dressman

    Version of Record online : 30 DEC 2013, DOI: 10.1002/jps.23817