Model-Based decision making in early clinical development: Minimizing the impact of a blood pressure adverse event

AAPS Journal

Volumn 11, Issue 1, 2009, Pages 99-108

  Stroh, Mark ^a   Addy, Carol ^a   Wu, Yunhui ^a   Stoch, S Aubrey ^a   Pourkavoos, Nazaneen ^a   Groff, Michelle ^a   Xu, Yang ^a   Wagner, John ^a   Gottesdiener, Keith ^a   Shadle, Craig ^a   Wang, Hong ^a   Manser, Kimberly ^a   Winchell, Gregory A ^a   Stone, Julie A ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Drug development; Phase I clinical trial; PK PD model

Indexed keywords

DRUG;

AREA UNDER THE CURVE; ARTICLE; CONTROLLED RELEASE FORMULATION; DIASTOLIC BLOOD PRESSURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG RESEARCH; HUMAN; HYPERTENSION; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PHARMACODYNAMICS; SIMULATION; SYSTOLIC BLOOD PRESSURE; THEORETICAL MODEL;

ADMINISTRATION, ORAL; ANIMALS; BIOLOGICAL AVAILABILITY; CIRCADIAN RHYTHM; CLINICAL TRIALS, PHASE I AS TOPIC; COLON; COMPUTER SIMULATION; DECISION MAKING; DELAYED-ACTION PREPARATIONS; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; GASTROINTESTINAL CONTENTS; HUMANS; HYPERTENSION; ILEUM; INTESTINAL ABSORPTION; JEJUNUM; MALE; MODELS, BIOLOGICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TABLETS; YOUNG ADULT;

EID: 65549155650     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-009-9083-6     Document Type: Article

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