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Pharmaceutics / Bioequivalence / Abbreviated New Drug Application / Food and Drug Administration / Cmax / Dissolution testing / Bioavailability / Methadone / Pharmaceutical sciences / Pharmacology / Pharmacokinetics


Guidance for Industry #35 - Bioequivalence Guidance, revised November, 8, 2006
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City

Rockville / /

Company

G. Manufacturing / /

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Event

Product Issues / Product Recall / FDA Phase / /

Facility

Animal Health Institute / /

IndustryTerm

finished drug product / appropriate reference product / physico-chemical characteristics / certain generic products / applied solutions / bioequivalence protocols / drug product / manufacturing change / reference product / generic product / proposed generic product / food animal species / off-patent product / pioneer product / non-food animals / proposed new generic product / food animal drug product / non-food / volatile anesthetic solutions / animal topical products / strength product / food-producing animals / drug products / generic products / strength products / /

Organization

U.S. Department of Health and Human Services / National Research Council / Food and Drug Administration Center for Veterinary Medicine / Food and Drug Administration / US Federal Reserve / Animal Health Institute / FOOD SAFETY / Center for Veterinary Medicine / National Academy of Sciences / American Academy of Veterinary Pharmacology and Therapeutics / /

Person

Valerie Reeves / /

/

Position

Governor / General / /

Product

study / period / ANADA / animal drug / solid / /

ProvinceOrState

Maryland / /

Technology

bioequivalence protocols / /

SocialTag