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Guidance for Industry

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Guidance for IndustryQ1A(R2) Stability Testingof New drug Substancesand Department of Health and Human ServicesFood and drug AdministrationCenter for drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)November 2003ICHRevision 2Guidance for IndustryQ1A(R2) Stability Testingof New drug Substancesand ProductsAdditional copies are available from:Office of Training and CommunicationDivision of drug Information, HFD-240Center for drug Evaluation and ResearchFood and drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573 of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and Research food and drug Administration1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) Voice Information System at 800-835-4709 or Department of Health and Human ServicesFood and drug AdministrationCenter for drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Nov

Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products U.S. Department of Health and Human Services Food and Drug Administration

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