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1151 PHARMACEUTICAL DOSAGE FORMS

Printed on: Fri May 14 2021, 10:26:22 AM Official Status: Currently Official on 14-May-2021 DocId: 1_GUID-431F93A9-1 FEC-42AE-8556-AA5B604B2E36_8_en-US. (EST). Printed by: Deborah Nishikawa Official Date: Official as of 01-May-2021 Document Type: GENERAL CHAPTER @2021 USPC. 1. 1151 PHARMACEUTICAL DOSAGE FORMS . Change to read: GENERAL CONSIDERATIONS. This chapter provides general descriptions of and definitions for drug products, or DOSAGE FORMS , commonly used to administer the drug substance (active PHARMACEUTICAL ingredient; API). It discusses general principles involved in the manufacture or compounding of these DOSAGE FORMS .

International Council for Harmonisation (ICH) Guidance Q6A (available at www.ich.org) recommends specifications (list of tests, references to analytical procedures, and acceptance criteria) to ensure that drug products are safe and effective …

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