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Clinical Pharmacology

The Clinical Pharmacology Team works to ensure that our clients' applications and other correspondence to the Food and Drug Administration are on the strongest scientific foundation.  This science serves as the basis for projecting public health impact, for marketing claims support, and for developing regulatory and public policy strategies with our Issues Management Team and Marketing Strategy Team. 

The Clinical Pharmacology Team: 

• Identifies and provides guidance on scientific issues that could impact regulatory approval, scheduling decisions, and risk management strategies
  
  
• Helps design and evaluate risk management programs
  
  
• Develops white papers, comprehensive literature reviews, and scientific reports for internal client use and peer-reviewed publications
  
  
• Designs and implements pharmacokinetic, abuse liability, and other clinical studies to meet the requirements of regulatory agencies and to support marketing claims
  
  
• Designs and implements pharmacokinetic studies to examine the bioavailability of drug formulations and optimize drug delivery systems
  
  
• Convenes expert meetings and provides expert testimony