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There are 210353 results for: content related to: Linkage of mother–baby pairs in the German Pharmacoepidemiological Research Database

  1. Implementation of ICHS6: EU Perspective

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Peter R. Ryle and David J. Snodin

    Published Online : 15 MAR 2010, DOI: 10.1002/9780470571224.pse163

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    Biosimilar epoetins and other “follow-on” biologics: Update on the European experiences

    American Journal of Hematology

    Volume 85, Issue 10, October 2010, Pages: 771–780, Wolfgang Jelkmann

    Article first published online : 29 JUN 2010, DOI: 10.1002/ajh.21805

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    Biosimilar agents in oncology/haematology: from approval to practice

    European Journal of Haematology

    Volume 86, Issue 4, April 2011, Pages: 277–288, Dietger Niederwieser and Stephan Schmitz

    Article first published online : 25 JAN 2011, DOI: 10.1111/j.1600-0609.2010.01566.x

  4. Regulatory Aspects of Drug Development for Dermal Products

    Transdermal and Topical Drug Delivery: Principles and Practice

    Heather A. E. Benson, Adam C. Watkinson, Pages: 217–232, 2012

    Published Online : 3 JAN 2012, DOI: 10.1002/9781118140505.ch12

  5. Therapeutic equivalence: fallacies and falsification

    Statistics in Medicine

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

    Article first published online : 5 FEB 2003, DOI: 10.1002/sim.1360

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    Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

    British Journal of Clinical Pharmacology

    Volume 68, Issue 4, October 2009, Pages: 493–501, Efthymios Manolis and Gérard Pons

    Article first published online : 26 JUN 2009, DOI: 10.1111/j.1365-2125.2009.03484.x

  7. Formulations, Impurities, and Toxicokinetics

    Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development

    Alberto Lodola, Jeanne Stadler, Pages: 83–107, 2011

    Published Online : 13 MAY 2011, DOI: 10.1002/9780470909911.ch6

  8. Pharmaceuticals, General Survey

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    Ullmann's Encyclopedia of Industrial Chemistry

    John L. McGuire, Horst Hasskarl, Gerd Bode, Ingrid Klingmann and Manuel Zahn

    Published Online : 15 APR 2007, DOI: 10.1002/14356007.a19_273.pub2

  9. Biochemical assessment of erythropoietin products from Asia versus US Epoetin alfa manufactured by Amgen

    Journal of Pharmaceutical Sciences

    Volume 98, Issue 5, May 2009, Pages: 1688–1699, Sungae S. Park, Jihea Park, Jason Ko, Louise Chen, David Meriage, Jill Crouse-Zeineddini, Wendy Wong and Bruce A. Kerwin

    Article first published online : 9 SEP 2008, DOI: 10.1002/jps.21546

  10. Toxicology and Adverse Drug Reactions

    Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

    D. J. Snodin, A. Suitters, Pages: 157–214, 2012

    Published Online : 30 JAN 2012, DOI: 10.1002/9780470975053.ch3

  11. Guidance on Immunogenicity Assessment of Biologically Derived Therapeutic Proteins: A European Perspective

    Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations

    Meenu Wadhwa, Robin Thorpe, Pages: 37–56, 2011

    Published Online : 20 JUN 2011, DOI: 10.1002/9781118075685.ch3

  12. Sample sizes for clinical trials with Normal data

    Statistics in Medicine

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

    Article first published online : 21 MAY 2004, DOI: 10.1002/sim.1783

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    Missing data: Discussion points from the PSI missing data expert group

    Pharmaceutical Statistics

    Volume 9, Issue 4, October/December 2010, Pages: 288–297, Tomasz Burzykowski, James Carpenter, Corneel Coens, Daniel Evans, Lesley France, Mike Kenward, Peter Lane, James Matcham, David Morgan, Alan Phillips, James Roger, Brian Sullivan, Ian White, Ly-Mee Yu and of the PSI Missing Data Expert Group

    Article first published online : 20 OCT 2009, DOI: 10.1002/pst.391

  14. Seven useful designs

    Pharmaceutical Statistics

    Volume 11, Issue 1, January/February 2012, Pages: 24–31, Steven A. Julious

    Article first published online : 5 MAY 2011, DOI: 10.1002/pst.485

  15. Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile

    Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

    John Talbot, Marianne Keisu, Lars Ståhle, Pages: 215–289, 2012

    Published Online : 30 JAN 2012, DOI: 10.1002/9780470975053.ch4

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

    Transfusion

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

    Article first published online : 28 JUN 2004, DOI: 10.1111/j.1537-2995.2004.03420.x

  17. Products used to Treat Hemophilia: Regulation

    Textbook of Hemophilia, Second Edition

    Christine A. Lee, Erik E. Berntorp, W. Keith Hoots, Pages: 170–175, 2010

    Published Online : 13 AUG 2010, DOI: 10.1002/9781444318555.ch26

  18. Modeling and Simulation in Clinical Drug Development

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    Pharmaceutical Sciences Encyclopedia

    Jerry Nedelman, Frank Bretz, Roland Fisch, Anna Georgieva, Chyi-Hung Hsu, Joseph Kahn, Ryosei Kawai, Phil Lowe, Jeff Maca, José Pinheiro, Anthony Rossini, Heinz Schmidli, Jean-Louis Steimer and Jing Yu

    Published Online : 15 MAR 2010, DOI: 10.1002/9780470571224.pse242

  19. Comments on assessment of drug-induced liver injury in clinical practice by Lucena MI et al., Fundamental & Clinical Pharmacology 2008; 22: 141–158

    Fundamental & Clinical Pharmacology

    Volume 22, Issue 6, December 2008, Page: 613, Fabio Macchi

    Article first published online : 28 NOV 2008, DOI: 10.1111/j.1472-8206.2008.00632_1.x

  20. Demonstration of Comparability of a Licensed Product after a Manufacturing Change

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Richard M. Lewis

    Published Online : 15 MAR 2010, DOI: 10.1002/9780470571224.pse167