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Health / Food and Drug Administration / Clinical research / Design of experiments / Fertility / Pregnancy / Clinical trial / Pharmacokinetics / Investigational New Drug / Pharmaceutical sciences / Pharmacology / Medicine


Guidance for Industry Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling DRAFT GUIDANCE
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Document Date: 2004-10-27 16:11:00


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File Size: 324,06 KB

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City

Rockville / /

Company

Pregnancy Working Group / /

Continent

Europe / /

Country

France / United States / /

Event

FDA Phase / /

IndustryTerm

biological products / term medical product / study protocol / anti-infective drug products / drug products / /

MedicalCondition

renal and hepatic disease / hypertension / cancer / stroke / pregnancy-induced hypertension / migraine headaches / epilepsy / asthma / /

MedicalTreatment

chemotherapy / drug therapy / /

Organization

U.S. Department of Health and Human Services / office of Human Research Protections / Institutional Review Board / Training and Communications Division of Drug Information / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / D. Drug Administration / Division of Dockets Management / office of Training / HFD-240 Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Pregnancy Labeling Task Force / /

Person

Kathleen Uhl / /

/

Position

investigator / Industry General / physician / representative / model the relationship / /

Product

nifedipine / Shure E2c Headphone/Headset / drugs / renally excreted drug / CYP2D6 / CYP450 / Industry1 / /

ProvinceOrState

Maryland / /

Technology

study protocol / Pharmacokinetics / chemotherapy / pharmacodynamics / Genotype / /

URL

http /

SocialTag