The animal rule and emerging infections: The role of clinical pharmacology in determining an effective dose

Clinical Pharmacology and Therapeutics

Volumn 86, Issue 3, 2009, Pages 328-331

  Bergman, K L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL ASSESSMENT; CLINICAL PHARMACOLOGY; DOSE RESPONSE; DRUG APPROVAL; DRUG INFORMATION; EXPERIMENTAL ANIMAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INFECTION; NONHUMAN; PRIORITY JOURNAL; SHORT SURVEY; UNITED STATES;

ANIMALS; ANTI-INFECTIVE AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; HUMANS; INFECTION; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 69449088646     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.106     Document Type: Short Survey

References (8)

1. US Food and Drug Administration, Center for Drug Evaluation and Research. Emerging Viral Infections. 〈http://www.fda.gov/cder/ode4/preind/emerging. htm〉 (2009).
2. US Food and Drug Administration, HHS. New drug and biologic drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule. Fed. Regist. 67, 37988-37998 (2002).
3. US Food and Drug Administration, HHS. Guidance for industry; animal models-essential elements to address efficacy under the animal rule (draft). 〈http://www.fda.gov/cder/guidance/8324dft.pdf〉 (2009).
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5. Andes, D. & Craig, W.A. Animal model pharmacokinetics and pharmacodynamics: a critical review. Int. J. Antimicrob. Agents 19, 261-268 (2002). (Pubitemid 34308974)
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7. Deziel, M.R. et al. Effective antimicrobial regimens for use in humans for therapy of Bacillus anthracis infections and postexposure prophylaxis. Antimicrob. Agents Chemother. 49, 5099-5106 (2005).
8. Kao, L.M. et al. Pharmacokinetic considerations and efficacy of levofloxacin in an inhalation anthrax (postexposure) Rhesus monkey model. Antimicrob. Agents Chemother. 50, 3535-3542 (2006).