Toward Greater Insights on Pharmacokinetics and Exposure-Response Relationships for Therapeutic Biologics in Oncology Drug Development

Author:

Wang Y1,Booth B1,Rahman A1,Kim G2,Huang SM1,Zineh I1

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration; Silver Spring Maryland USA

2. Office of Hematology and Oncology Products, Office of New Drugs, US Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference10 articles.

1. Wang , Y. Sinha , V. Impact of Dose-Exposure-Response (D-R-E) Information on Regulatory Approval and Post Authorisation Commitments: FDA Perspective. European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2015/01/WC500179818.pdf

2. Seamless oncology-drug development;Prowell;N. Engl. J. Med.,2016

3. Guidance for Industry, Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm072109.pdf

4. The combination of exposure-response and case-control analyses in regulatory decision making;Yang;J. Clin. Pharmacol.,2013

5. Liu , J. Wang , Y. Zhao , L. Assessment of exposure-response and case-control analyses in oncology using simulation based approach

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