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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) 796-0074 Fax: (301) 796-9818
Vincent L. Vilker, Ph. D., Acting 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.
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Date created: October 2, 2006 |
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