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U.S. Department of Health and Human Services

About FDA

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Division of Applied Pharmacology Research

Federal Research Center
Life Sciences Building 64, HFD-910
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-00784 Fax: (301) 796-9818
Thomas J. Colatsky, Ph. D., Director


 

The Division of Applied Pharmacology Research focuses on nonclinical pharmacology/toxicology laboratory research that will establish the best models and endpoints for accurately predicting the clinical effects of therapeutics. 

The impacts of DAPR's laboratory research programs are

  • improving public health
  • minimizing the human risks associated with pharmaceuticals
  • facilitating regulatory decision making
  • economizing the drug approval process and minimizing regulatory burden while maintaining high product performance standards for efficacy and safety 

The goals of DAPR are 

  • to provide, in a timely manner, reliable laboratory research data to solve critical well-defined "rapid response," or "brush-fire" regulatory review, guidance development, or citizen petition issues.
  • to optimize applications of new technologies to develop improved mechanistically-based endpoints that will be predictive of delayed and insidious, or irreversible, toxicities that are not easily detected in human clinical trials or through human postmarketing surveillance. These endpoints should be specifically directed at minimizing potential for human suffering and reducing the regulatory uncertainty in making interspecies extrapolations.
  • to bridge nonclinical mechanistically-based endpoints, practical biomarkers of effect, and predictive biomarkers of susceptibility to clinical efficacy and toxicity and thereby guide rational dose selection for initiation of Phase I trials and rapid and safe progression from Phase I to Phase III studies.
  • to incorporate measurements of preclinical and clinical drug exposure levels, and biomarkers of drug exposure for quantitative nonclinical-to-clinical extrapolation.
  • to provide model systems and mechanistic endpoints that accurately predict and establish adverse and beneficial clinical effects of those drug-drug interactions which could result in a modification of drug labeling, trial design, or reviewer guidance.
  • to evaluate the impact of proposed regulatory methods, models and endpoints upon the clinical development and regulatory evaluation of emerging classes of NME's, and, if there is positive impact, strategize to incorporate the proposed predictive endpoints into regulatory decision-making.