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Xem thêm: Handbook of pharmaceut vol 4 semisolid products , Part II. Formulations of Semisolid Drugs, D. MINOR CHANGES (ANNUAL REPORT), C. MODERATE CHANGES (SUPPLEMENT —CHANGES BEING EFFECTED, C. MINOR CHANGES (ANNUAL REPORT), Chapter 2. Postapproval Changes to Semisolid Drugs, II. PARTICLE SIZE REDUCTION AND SEPARATION, II. STABILITY TESTING FOR NEW DRUG APPLICATIONS, F. EXPIRATION DATING PERIOD AND RETEST PERIOD, Original NDAs, BLAs, or PLAs, N. STABILITY TESTING OF BIOTECHNOLOGY DRUG PRODUCTS, H. CHANGES IN THE STABILITY PROTOCOL, E. DATA EVALUATION FOR RETEST PERIOD OR SHELF -LIFE ESTIMATION FOR DRUG SUBSTANCES OR PRODUCTS INTENDED FOR STORAGE BELOW “ROOM TEMPERATURE”, B. RECOMMENDATIONS FOR A SKIN SENSITIZATION STUDY (MODIFIED DRAIZE TEST, C. MECHANISTICALLY BASED AND OTHER ASSAYS