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Food and Drug Administration / Food law / Pharmaceutical industry / Clinical pharmacology / Pharmacometrics / Federal Food / Drug / and Cosmetic Act / Clinical trial / New Drug Application / Pharmacokinetics / Pharmacology / Pharmaceutical sciences / Clinical research


General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products
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City

Rockville / /

Company

Pediatric Working Group / /

/

Event

FDA Phase / Product Issues / /

Facility

Hillandale Bldg. / /

/

IndustryTerm

absorption site / biological products / gastrointestinal drug-metabolizing enzyme systems / biologics license applications / blood products / age / biological product / biologic products / /

MedicalCondition

concomitant illness / disease / prior disease / biliary and pulmonary routes / /

MedicalTreatment

vaccine therapy / /

Organization

U.S. Department of Health and Human Services / Congress / Food and Drug Administration Center for Drug Evaluation and Research / Coordinating Committee / Food and Drug Administration / Division of Dockets Management / office of Communications / Food and Drug Administration Center for Drug Evaluation / Pediatric Subcommittee of the Medical Policy / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / office of Clinical Pharmacology / Drug Information Center for Drug Evaluation / /

Person

Gilbert J. Burckart / /

/

Position

Major / General / Secretary / Clinical Pharmacology General / /

Product

drugs / inadequate pediatric use information / pediatric testing / /

ProvinceOrState

Maryland / /

Technology

alpha / pharmacogenomic / Pharmacokinetics / Drug metabolism / Pharmacogenetics / gene expression / Pharmacodynamics / drug development / /

URL

http /

SocialTag