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Clinical research / Research / Quality / Pharmaceuticals policy / Quality by Design / Food and Drug Administration / Validation / Bioequivalence / Process analytical technology / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry


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City

Rockville / /

Company

Expert Working Group / /

Country

Japan / United States / /

Facility

Rockville Pike / /

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IndustryTerm

expected and documented manufacturing losses / pharmaceutical development / manufacturing controls / manufacturing experience / container closure systems / drug product / analytical technology / manufacturing process improvements / quality risk management / lifecycle management / manufacturing process options / final formulated product / pharmaceutical and manufacturing sciences / real-time quality control / manufacturing process development program / physical and chemical attributes / drug products / pharmaceutical development studies / manufacturing processes / manufacturing process / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / fda / office of Communication / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /

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Product

M-16 / R2 / /

ProvinceOrState

Maryland / /

Technology

Biotechnology / process control / drug development / /

URL

http /

SocialTag