Impact of pharmacometric analyses on new drug approval and labelling decisions: A review of 198 submissions between 2000 and 2008

Clinical Pharmacokinetics

Volumn 50, Issue 10, 2011, Pages 627-635

  Lee, Joo Yeon ^a   Garnett, Christine E ^a   Gobburu, Jogarao V S ^a   Bhattaram, Venkatesh A ^a   Brar, Satjit ^a   Earp, Justin C ^a   Jadhav, Pravin R ^a   Krudys, Kevin ^a   Lesko, Lawrence J ^a   Li, Fang ^a   Liu, Jiang ^a   Madabushi, Rajnikanth ^a   Marathe, Anshu ^a   Mehrotra, Nitin ^a   Tornoe, Christoffer ^a   Wang, Yaning ^a   Zhu, Hao ^a  

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

Author keywords

Clinical trial design; Dose prediction; Labelling; Pharmacodynamic modelling; Pharmacokinetic modelling; Pharmacokinetic pharmacodynamic relationships; Population pharmacokinetics; Product approvals; Regulatory process

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CANAKINUMAB; CLEVIDIPINE; LAMOTRIGINE; PLACEBO; VALPROIC ACID;

CINCA SYNDROME; DRUG APPROVAL; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG LABELING; DRUG SURVEILLANCE PROGRAM; EVALUATION; FOCAL EPILEPSY; HUMAN; HYPERTENSION; LENNOX GASTAUT SYNDROME; MEDICAL DECISION MAKING; PHARMACOLOGICAL SCIENCE; PHARMACOMETRIC ANALYSIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVIEW; TONIC CLONIC SEIZURE;

CLINICAL TRIALS AS TOPIC; DECISION SUPPORT TECHNIQUES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG LABELING; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; MODELS, BIOLOGICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80052495952     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11593210-000000000-00000     Document Type: Review

References (11)

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