Pediatrik kullanım amaçlı ilaçların geliştirilmesine dair taslak kılavuz (İng)

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Draft guideline on pharmaceutical development of medicines for paediatric use.

The European Medicines Agency (EMA) has released a newly-revised draft guideline regarding the development of pharmaceutical products intended for use in children, taking into account comments received on a draft version released in 2011. This guideline is intended to provide additional guidance for the pharmaceutical development of medicinal products for children from birth to less than 18 years of age. This guideline should be read in conjunction with all other relevant EU legislative and guiding documents. The guideline takes due account of the scientific and technical progress in the manufacture and control of pediatric medicines at the date of coming into operation.

The changes made to the initial draft guideline significant enough for EMA to partially restart the comment period on the guideline, which is now open through 31 March 2013.  Points below which are opened for the second consultation are :

  1. Section 6.2.1: Handling of oral solid preparations to facilitate administration Additional paragraph under section 6.2 has been proposed to address handling of oral solid preparations which is done to facilitate administration. This section combines and expands on initially proposed sections on Sub-division of tablets and Crushing tablets.
  2. Section 10: Mixing with food Mixing with food and drinks may be an important approach for assuring or improving patient’s acceptability, or to facilitate administration of medicines to children. Therefore additional section dedicated to this aspect has been included in the revised Guideline.

Patients acceptability: Assurance of patients’ acceptability through out the life cycle of a medicinal product plays an important role in treatment compliance. This section of the guideline highlights the need to consider additional studies when changes to the formulation (re-formulation of the product) are proposed and it is apparent that such changes may affect acceptability, including palatability of the product. In addition this section of the guideline has been amended to reflect on importance of the choice of the method to be used for confirmation of the patients’ acceptability.