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PDF Downloads
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The Future of Drug Development: Advancing Clinical Trial Design
This paper, co-authored by Dr. Golub, describes the need to move away from the traditional clinical development approach based on sequential, distinct phases towards a more integrated view that uses adaptive design tools to increase flexibility and maximize accumulated knowledge critical to the execution of efficient and cost-effective drug development. [Nature Review Drug Discovery, Volume 8, AOP 9 October 2009]
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Guidance Document: Data Monitoring Committees
Published by HHS, FDA, CBER, CDER and CDRH in March 2006, this guidance document for Sponsors describes the roles, responsibilities and operating procedures for the establishment and operation of clinical trial data monitoring committeees.
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Guidance Document: Pharmacovigilance and Pharmacoepidemiology
This document provides guidance on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs and drug products, including safety signal identification, pharmacoepidemiologic assessment, safety signal interpretation and pharmacovigilance plan development.
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Post Approval Safety Surveillance and Pharmacovigilance
This is a presentation that was developed to describe the history and current state of safety surveillance and pharmacovigilance.
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