Reporting guidelines for population pharmacokinetic analyses

Journal of Clinical Pharmacology

Volumn 55, Issue 8, 2015, Pages 875-887

  Dykstra, Kevin ^a   Mehrotra, Nitin ^b   Tornøe, Christoffer Wenzel ^c   Kastrissios, Helen ^d   Patel, Bela ^e   Al Huniti, Nidal ^f   Jadhav, Pravin ^g   Wang, Yaning ^b   Byon, Wonkyung ^h  

^a qPharmetra LLC   (United States)

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

^c NOVO NORDISK A S   (Denmark)

^d CERTARA   (United States)

^e GLAXOSMITHKLINE   (United States)

^f ASTRAZENECA   (United Kingdom)

^g MERCK RESEARCH LABORATORIES   (United States)

^h PFIZER INC   (United States)

Author keywords

Best practices; PK reporting; Population pharmacokinetics; Regulatory submission

Indexed keywords

CLINICAL PHARMACOLOGY; CLINICAL TRIAL (TOPIC); DECISION MAKING; DRUG DEVELOPMENT; HUMAN; INDUSTRIALIZATION; INTERPERSONAL COMMUNICATION; LIMIT OF QUANTITATION; MAXIMUM PLASMA CONCENTRATION; PHARMACEUTICS; PHARMACOKINETICS; POPULATION RESEARCH; PRACTICE GUIDELINE; PUBLICATION; REVIEW; STANDARDIZATION; BIOLOGICAL MODEL; QUESTIONNAIRE;

COMMUNICATION; GUIDELINES AS TOPIC; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; SURVEYS AND QUESTIONNAIRES;

EID: 84936084802     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.532     Document Type: Review

References (11)

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