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There are 35758 results for: content related to: Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials

  1. 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

  2. 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

  3. Role of modeling and simulation in pediatric investigation plans

    Pediatric Anesthesia

    Volume 21, Issue 3, March 2011, Pages: 214–221, Efthymios Manolis, Tariq Eldirdiry Osman, Ralf Herold, Franz Koenig, Paolo Tomasi, Spiros Vamvakas and Agnes Saint Raymond

    Article first published online : 18 JAN 2011, DOI: 10.1111/j.1460-9592.2011.03523.x

  4. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases

    Alimentary Pharmacology & Therapeutics

    Volume 38, Issue 8, October 2013, Pages: 914–924, M. Rinaudo-Gaujous, S. Paul, E. D. Tedesco, C. Genin, X. Roblin and L. Peyrin-Biroulet

    Article first published online : 3 SEP 2013, DOI: 10.1111/apt.12477

  5. Quality of Inhalation Products: Specifications

    Inhalation Drug Delivery: Techniques and Products

    Paolo Colombo, Francesca Buttini, Wong Tin Wui, Pages: 169–190, 2013

    Published Online : 22 FEB 2013, DOI: 10.1002/9781118397145.ch9

  6. Application of Dried Blood Spot Sampling in Clinical Pharmacology Trials and Therapeutic Drug Monitoring

    Dried Blood Spots: Applications and Techniques

    Kenneth Kulmatycki, Wenkui Li, Xiaoying (Lucy) Xu, Venkateswar Jarugula, Pages: 216–228, 2014

    Published Online : 13 JUN 2014, DOI: 10.1002/9781118890837.ch19

  7. Quality Assurance Requirements in Plasma Product Manufacture

    Production of Plasma Proteins for Therapeutic Use

    Joseph Bertolini, Neil Goss, John Curling, Pages: 381–401, 2012

    Published Online : 14 DEC 2012, DOI: 10.1002/9781118356807.ch28

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    ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies

    British Journal of Clinical Pharmacology

    Volume 75, Issue 4, April 2013, Pages: 959–965, Rashmi R. Shah and Joel Morganroth

    Article first published online : 15 MAR 2013, DOI: 10.1111/j.1365-2125.2012.04442.x

  9. Development of the Threshold of Toxicological Concern Concept and its Relationship to Duration of Exposure

    Genotoxic Impurities

    Alessandro Brigo, Lutz Müller, Pages: 27–63, 2011

    Published Online : 3 JAN 2011, DOI: 10.1002/9780470929377.ch2

  10. Tutorial in biostatistics: sample sizes for parallel group clinical trials with binary data

    Statistics in Medicine

    Volume 31, Issue 24, 30 October 2012, Pages: 2904–2936, Steven A. Julious and Michael J. Campbell

    Article first published online : 19 JUN 2012, DOI: 10.1002/sim.5381

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    Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?

    British Journal of Clinical Pharmacology

    Volume 75, Issue 1, January 2013, Pages: 7–14, John B. Warren

    Article first published online : 14 DEC 2012, DOI: 10.1111/j.1365-2125.2012.04323.x

  12. Optimized Nonclinical Safety Assessment Strategies Supporting Clinical Development of Therapeutic Monoclonal Antibodies Targeting Inflammatory Diseases

    Drug Development Research

    Volume 75, Issue 3, May 2014, Pages: 115–161, Frank R. Brennan, Annick Cauvin, Jay Tibbitts and Alison Wolfreys

    Article first published online : 29 APR 2014, DOI: 10.1002/ddr.21173

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    Non-clinical safety evaluation of single and repeated intramuscular administrations of MAGE-A3 Cancer Immunotherapeutic in rabbits and cynomolgus monkeys

    Journal of Applied Toxicology

    Eric Destexhe, Emilie Grosdidier, Nathalie Baudson, Roy Forster, Catherine Gerard, Nathalie Garçon and Lawrence Segal

    Article first published online : 12 SEP 2014, DOI: 10.1002/jat.3025

  14. You have free access to this content
    Bibliography

    Clinical Trials with Missing Data: A Guide for Practitioners

    Michael O'Kelly, Bohdana Ratitch, Pages: 409–421, 2014

    Published Online : 21 FEB 2014, DOI: 10.1002/9781118762516.biblio

  15. A general approach for sample size calculation for the three-arm ‘gold standard’ non-inferiority design

    Statistics in Medicine

    Volume 31, Issue 28, 10 December 2012, Pages: 3579–3596, Kathrin Stucke and Meinhard Kieser

    Article first published online : 4 JUL 2012, DOI: 10.1002/sim.5461

  16. Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment

    British Journal of Haematology

    Volume 162, Issue 1, July 2013, Pages: 107–111, Amy Publicover, Deborah S. Richardson, Andrew Davies, Kate S. Hill, Carol Hurlock, David Hutchins, Matthew W. Jenner, Peter W. Johnson, Jane Lamb, Harriet Launders, Nikki McKeag, Joan Newman and Kim H. Orchard

    Article first published online : 25 APR 2013, DOI: 10.1111/bjh.12345

  17. You have full text access to this OnlineOpen article
    Subcutaneous abatacept versus intravenous abatacept: A phase IIIb noninferiority study in patients with an inadequate response to methotrexate

    Arthritis & Rheumatism

    Volume 63, Issue 10, October 2011, Pages: 2854–2864, M. C. Genovese, A. Covarrubias, G. Leon, E. Mysler, M. Keiserman, R. Valente, P. Nash, J. A. Simon-Campos, W. Porawska, J. Box, C. Legerton III, E. Nasonov, P. Durez, R. Aranda, R. Pappu, I. Delaet, J. Teng and R. Alten

    Article first published online : 27 SEP 2011, DOI: 10.1002/art.30463

  18. Biosimilars: how similar?

    Internal Medicine Journal

    Volume 44, Issue 3, March 2014, Pages: 218–223, V. Strand and B. Cronstein

    Article first published online : 13 MAR 2014, DOI: 10.1111/imj.12292

  19. Nonclinical Safety Assessment of Biologics, Including Vaccines

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Liangbiao George Hu and David W. Clarke

    Published Online : 25 NOV 2013, DOI: 10.1002/9780470571224.pse501

  20. Methods to Derive Withdrawal Periods in the European Union

    Strategies for Reducing Drug and Chemical Residues in Food Animals: International Approaches to Residue Avoidance, Management, and Testing

    G. Johan Schefferlie, Stefan Scheid, Pages: 65–79, 2014

    Published Online : 11 AUG 2014, DOI: 10.1002/9781118872819.ch5