Designing drug trials: Considerations for pregnant women

Clinical Infectious Diseases

Volumn 59, Issue , 2014, Pages S437-S444

  Sheffield, Jeanne S ^a   Siegel, David ^b   Mirochnick, Mark ^c   Heine, R Phillips ^d   Nguyen, Christine ^e   Bergman, Kimberly L ^f   Savic, Rada M ^g   Long, Jill ^h   Dooley, Kelly E ⁱ   Nesin, Mirjana ^h  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^c BOSTON UNIVERSITY   (United States)

^d DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Center for Drug Evaluation and Research   (United States)

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

^g UNIVERSITY OF CALIFORNIA   (United States)

^h NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Drug trials; Pharmacokinetics; Pregnancy

Indexed keywords

NEW DRUG;

ARTICLE; DRUG DESIGN; DRUG DEVELOPMENT; DRUG EFFECT; DRUG LEGISLATION; DRUG SCREENING; FEMALE; HUMAN; PHARMACODYNAMIC PARAMETERS; PHARMACOKINETIC PARAMETERS; PLACENTA FUNCTION; PRECLINICAL STUDY; PREGNANCY; PREGNANT WOMAN; PRIORITY JOURNAL; STUDY DESIGN; VULNERABLE POPULATION; ADULT; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); FETOMATERNAL TRANSFUSION; FOOD AND DRUG ADMINISTRATION; INFANT; METHODOLOGY; PHARMACOKINETICS; PHYSIOLOGY; PLACENTA; PREGNANCY OUTCOME; UNITED STATES;

ADULT; CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; INFANT; MATERNAL-FETAL EXCHANGE; PHARMACOKINETICS; PLACENTA; PREGNANCY; PREGNANCY OUTCOME; PREGNANT WOMEN; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84979862120     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciu709     Document Type: Article

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