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When the feasibility of administering a particular medicinal product through an enteral feeding tube is to be investigated, feasibility studies should address the following: It elaborates on the issue raised in the Guideline on pharmaceutical development of medicines for paediatric use.
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Specific types of product - Quality of investigational medicinal products.Specific types of product - Orally inhaled products.
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Quality data requirements to demonstrate suitability of multidose containers for preservative free eye drops NEW October 2018.Particles originated from the container closure system.Claims for in-use shelf-life for solid oral dosage forms in multi-dose containers.Design of in-use shelf life for solid oral dosage forms in multi-dose containers.Active substance - Veterinary Medicinal Products (VMP) containing 100% Active Substance (V) NEW Sept.
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Definition of ‘active substance’ in relation to mixtures.Appearance of tablets of different strengths.Acceptability of two different appearances (shape, dimensions, colour) for a single strength tablet in a single Marketing Authorisation.Administration of oral immediate release medicinal products through enteral feeding tubes NEW December 2018.