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There are 7506 results for: content related to: Regulatory environment for allergen-specific immunotherapy

  1. An efficient test for the analysis of dichotomized variables when the reliability is known

    Statistics in Medicine

    Volume 26, Issue 18, 15 August 2007, Pages: 3498–3510, George F. Borm, Marten Munneke, Oscar Lemmers and Martien van Zuijlen

    Version of Record online : 15 SEP 2006, DOI: 10.1002/sim.2705

  2. Special Invited Papers Section: Therapeutic Equivalence – Clinical Issues and Statistical Methodology in Noninferiority Trials

    Biometrical Journal

    Volume 47, Issue 1, February 2005, Pages: 12–27, S. Lange and G. Freitag

    Version of Record online : 15 FEB 2005, DOI: 10.1002/bimj.200410085

  3. Therapeutic equivalence: fallacies and falsification

    Statistics in Medicine

    Volume 22, Issue 5, 15 March 2003, Pages: 741–762, Andrew D. Garrett

    Version of Record online : 5 FEB 2003, DOI: 10.1002/sim.1360

  4. Power and sample size determination when assessing the clinical relevance of trial results by ‘responder analyses’

    Statistics in Medicine

    Volume 23, Issue 21, 15 November 2004, Pages: 3287–3305, Meinhard Kieser, Joachim Röhmel and Tim Friede

    Version of Record online : 18 OCT 2004, DOI: 10.1002/sim.1910

  5. You have free access to this content
    Registration trials for specific immunotherapy in Europe: advanced guidance from the new European Medical Agency guideline


    Volume 65, Issue 12, December 2010, Pages: 1499–1505, V. Gödicke and F. Hundt

    Version of Record online : 29 OCT 2010, DOI: 10.1111/j.1398-9995.2010.02436.x

  6. You have free access to this content
    Health-Related Quality of Life and Other Patient-Reported Outcomes in the European Centralized Drug Regulatory Process: A Review of Guidance Documents and Performed Authorizations of Medicinal Products 1995 to 2003

    Value in Health

    Volume 8, Issue 5, September/October 2005, Pages: 534–548, Ágota Szende, Nancy K. Leidy and Dennis Revicki

    Version of Record online : 1 SEP 2005, DOI: 10.1111/j.1524-4733.2005.00051.x

  7. Drug Metabolism in Regulatory Guidances, Clinical Trials, and Product Labeling

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Mark N. Milton

    Published Online : 15 MAR 2010, DOI: 10.1002/9780470571224.pse126

  8. Adjustment for baseline covariates: an introductory note

    Statistics in Medicine

    Volume 23, Issue 5, 15 March 2004, Pages: 697–699, Jean-Marie Grouin, Simon Day and John Lewis

    Version of Record online : 11 FEB 2004, DOI: 10.1002/sim.1646

  9. Drug Metabolism in Regulatory Guidances, Clinical Trials, and Product Labeling

    Drug Metabolism Handbook: Concepts and Applications

    Ala F. Nassar, Paul F. Hollenberg, JoAnn Scatina, Pages: 783–1000, 2008

    Published Online : 4 AUG 2008, DOI: 10.1002/9780470439265.ch27

  10. Measurement in clinical trials: A neglected issue for statisticians?

    Statistics in Medicine

    Volume 28, Issue 26, 20 November 2009, Pages: 3189–3209, Stephen Senn and Steven Julious

    Version of Record online : 19 MAY 2009, DOI: 10.1002/sim.3603

  11. Sample sizes for clinical trials with Normal data

    Statistics in Medicine

    Volume 23, Issue 12, 30 June 2004, Pages: 1921–1986, Steven A. Julious

    Version of Record online : 21 MAY 2004, DOI: 10.1002/sim.1783

  12. Pathogen safety of plasma-derived products – Haemate® P/Humate-P®


    Volume 14, Issue s5, November 2008, Pages: 54–71, A. GRÖNER

    Version of Record online : 29 AUG 2008, DOI: 10.1111/j.1365-2516.2008.01852.x

  13. You have free access to this content
    Inactivation of parvovirus B19 by liquid heating incorporated in the manufacturing process of human intravenous immunoglobulin preparations

    British Journal of Haematology

    Volume 128, Issue 3, February 2005, Pages: 401–404, Mikihiro Yunoki, Takeru Urayama, Muneo Tsujikawa, Yoshie Sasaki, Shunichi Abe, Kazuo Takechi and Kazuyoshi Ikuta

    Version of Record online : 13 DEC 2004, DOI: 10.1111/j.1365-2141.2004.05309.x

  14. Noninferiority hypotheses and choice of noninferiority margin

    Statistics in Medicine

    Volume 27, Issue 26, 20 November 2008, Pages: 5392–5406, Tie-Hua Ng

    Version of Record online : 4 AUG 2008, DOI: 10.1002/sim.3367

  15. Quality Control of pDNA

    Plasmids for Therapy and Vaccination

    Andreas Fels, Ruth Baier, Andreas Richter, Pages: 237–253, 2007

    Published Online : 11 DEC 2007, DOI: 10.1002/9783527612833.ch12

  16. Purpose and Design of Clinical Trials

    The Textbook of Pharmaceutical Medicine, 6th Edition

    John P. Griffin, Pages: 185–206, 2009

    Published Online : 18 NOV 2009, DOI: 10.1002/9781444317800.ch6

  17. Different susceptibility of B19 virus and mice minute virus to low pH treatment


    Volume 44, Issue 7, July 2004, Pages: 1079–1086, Nicola Boschetti, Isabel Niederhauser, Christoph Kempf, Albert Stühler, Johannes Löwer and Johannes Blümel

    Version of Record online : 28 JUN 2004, DOI: 10.1111/j.1537-2995.2004.03420.x

  18. Non-parametric assessment of non-inferiority with censored data

    Statistics in Medicine

    Volume 25, Issue 7, 15 April 2006, Pages: 1201–1217, G. Freitag, S. Lange and A. Munk

    Version of Record online : 12 DEC 2005, DOI: 10.1002/sim.2444

  19. Analytics in Quality Control and In vivo

    Modern Biopharmaceuticals: Design, Development and Optimization

    Jörg Knäblein, Pages: 1556–1579, 2008

    Published Online : 5 FEB 2008, DOI: 10.1002/9783527620982.ch65

  20. Basic Concepts for the Development of a Biosimilar Product: Experience with Omnitrope®, the First Ever Approved Similar Biopharmaceutical Product

    Modern Biopharmaceuticals: Recent Success Stories

    Alexander Berghout, Andreas Premstaller, Mark McCamish, Pages: 401–428, 2013

    Published Online : 23 APR 2013, DOI: 10.1002/9783527669417.ch18