Clinical Investigation Of Medicinal Products In
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ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF …
database.ich.orgClinical Investigation of Medicinal Products in the Pediatric Population 4 . of medicinal products in pediatric patients is an important goal. However, this should be done without compromising the well-being of pediatric patients participating in clinical studies. This
GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
database.ich.org3.1.2 Quality of Investigational Medicinal Products Formulations used in clinical trials should be well characterised, including information on bioavailability wherever feasible. The formulation should be appropriate for the stage of drug development. Ideally, the supply of a formulation
Guideline on the clinical development of medicinal ...
www.ema.europa.euGuideline on the clinical development of medicinal products intended for the treatment of pain EMA/CHMP/970057/2011 Page 4/29 1. Executive summary This Guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain. It replaces and updates the separate guidelines on neuropathic
Guideline on clinical development of fixed combination ...
www.ema.europa.euThe guideline primarily discusses the development of fixed combination medicinal products with two active substances. However, it is expected that the same principles would generally apply to fixed combination medicinal products containing three or more active substances.