إجراء مقترح من تشيلي: الأدوية واللقاحات

The notified guide aims to update the practices and requirements applicable to the conduct and submission of bioequivalence studies on solid oral dosage forms with systemic action, including capsules, tablets, coated tablets, orodispersible tablets, chewable tablets and aqueous suspensions. Furthermore, the guide seeks to review and supplement the concepts set out in the Standard Defining Criteria for Establishing Therapeutic Equivalence of Pharmaceutical Products in Chile (Exempt Decree No. 27/2012), bringing them into line with current international technical guidelines.This regulatory update describes the scientific and technical aspects relating to the design of studies and the analysis of data intended to support the assessment of bioequivalence based on pharmacokinetic variables applicable to solid oral dosage forms.