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Clinical Research Updates - Regulatory Processes in the USA Product Image

Clinical Research Updates - Regulatory Processes in the USA

  • Published: June 2012
  • Region: World
  • Euromed Communications Ltd

Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.

Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a clinical research program - from drug discovery through post marketing surveillance - in the US or abroad.

Focusing on the US, Europe and Asia, Clinical Research Updates have been updated in 2012 to make it the most current and comprehensive resource available

Introduction
Overview of the US Drug Development and Approval Process
Drug Development: Time, Cost, Success Rate
The Investigational New Drug Process
Forms FDA 1571 and 1572
IND: Administrative Aspects
IND: FDA Focus
Informed consent
Phases of Clinical Development
Updating the IND
Numbers of Clinical Subjects
Adequate and Well-Controlled Studies
Interaction between Sponsor and FDA
The New Drug Application Process
NDA Content and Format
Quality of Data
Quality of application
Reputation of the Sponsor
NDA Review and Filing Clocks
Drug Classification and Priority Review Policy
Interaction between Sponsor and FDA
Changes to a Pending NDA
The Pre-Approval Inspection
The Action Letter
Post-approval Phase
Post-Approval Changes to the NDA
Conclusion
References

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