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Search results with tag "Acting products"
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE …
www.ema.europa.euLocally Acting Products Containing Known Constituents; CPMP/180/95: Guideline for PMS Studies for Metered Dose Inhalers with New Propellants; CPMP/EWP/240/95 Rev.1: Guideline on the Clinical Development of Fixed Combination
Guideline o the Investigation of Bioequivalence
www.ema.europa.eu− Fixed Combination Medicinal Products (CPMP/EWP/240/95 Rev 1) ... Locally Acting Products containing Known Constituents (CPMP/EWP/239/95) ... If two formulations are compared, a randomised, two-period, two-sequence single dose crossover design is recommended. The treatment periods should be separated by a wash out period sufficient to