美国FDA 指导原则 速释固体口服制剂的溶出度试验 英文原版.pdfVIP

Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 1997 BP 1 Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms Additional copies are available from: Office of Training and Communications Division of Communications Management The Drug Information Branch, HFD-210 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 (Internet) /cder/guidance.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 1997 BP 1 Table of Contents I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 III. BIOPHARMACEUTICS CLASSIFICATION SYSTEM . . . . . . . . . . . . . . . . . . . . . .