Analysis of integrated clinical trial protocols in early phases of medicinal product development

Author:

Fruhner Kevin,Hartmann Gunther,Sudhop ThomasORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference34 articles.

1. ICH Expert Working Group (1997) ICH harmonised tripartite guideline: general considerations for clinical trials E8. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf . Accessed 05 Jun 2017

2. National Health Service UK (2016) Clinical trials and medical research—phases of trials. http://www.nhs.uk/conditions/clinical-trials/Pages/Phasesoftrials.aspx . Accessed 05 Jun 2017

3. National Institute of Health (2017) NIH clinical research trials and you—the basics. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics . Accessed 05 Jun 2017

4. Hasford J (2016) String protocols from phase I to approval? Original title: Kettenprotokolle von der phase I bis zur Zulassung? 24. BVMA-symposium, Munich 11/25/2016

5. Applied Clinical Trials, Quintiles© (2009) Early-phase optimization stategies: model based testing and integrated protocols set the stage for phase III success. http://www.quintiles.com/%7E/media/library/media%20coverage/early-phase-optimization-strategies.pdf . Accessed 05 Jun 2017

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