Search results with tag "Fixed combination"
Guideline on clinical development of fixed combination ...
www.ema.europa.eudevelopment of herbal fixed combinations as well as those composed of vitamins, oligo- elements and minerals are also outside of the scope of this guideline. Guideline on clinical development of fixed combination medicinal products EMA/CHMP/158268/2017 Page 4/12 : 3. Legal basis and relevant guidelines
COMPARISON OF IOP LOWERING EFFICACY BRIMONIDINE …
www.mch-ophthal.comimprove patient compliance2, fixed combinations of IOP-lowering medications also reduce the likelihood of drug dilution caused by the instillation of multiple eye drops, minimize ocular exposure to preservatives3, and may lead to a decrease in costs and patient copayments for the medications4. The fixed combination of dorzolamide 2% and timolol 0.5% (MISOPT) has been
Module VII VII.B.5 Format and contents of the PSUR
www.jfda.joimportant safety findings from use of the combination therapy. If the product itself is a fixed combination product, this PSUR sub-section should …
Nonclinical Safety Studies for the Conduct of Human ...
database.ich.orgFixed Combination drug non-clinical studies. Acute Toxicity Studies ... For multiple dose clinical development trials, choice of two batteries of tests, Option 1 and Option 2: described in the ICH S2R document . Reproduction Toxicity Studies (a)
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) − Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD)