DEVELOPMENT AND PRODUCTION OF SOLID DOSAGE FORMS

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The Pharmaceutical Resources Branch of the Developmental Therapeutics Program, Division of Cancer Treatment, National Cancer Institute (NCI), is seeking a contractor to provide a staff and facility for the manufacture and production of solid oral dosage forms for investigational use in man. The number of production assignments will approximate six projects annually consisting of batch sizes from 10,000 to 300,000 tablets/capsules. The products prepared will be usedfor NCI-sponsored clinical trials throughout the world. Data obtained from this contractor will be used by NCI personnel to evaluate the integrity of the product, and to support IND applications submitted by the NCI to the U. S. Food and Drug Administration (FDA).