Identification and quantification of impurities: a crucial aspect in pharmaceutical development

Introduction Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient is considered an impurity. The presence of impurities, even in small amounts, may influence the efficacy and / or safety of the drug, hence the importance of their toxicological assessment and control. Impurities…

Mutagenic impurities assessment following ICH M7 guideline

Mutagenic impurities assessment following ICH M7 guideline comprises impurities identification and classification, followed by a control strategy when DNA reactivity is confirmed for the impurity. According to this guideline, the first step in impurities assessment consist on the identification of both actual and potential impurities which could arise in the drug substance or product synthesis…

Toxicological assesments using (quantitative) structure-activity relationships ((Q)SAR) methodologies

When assessing pharmacological and toxicological profile of chemical structures, several approaches are possible, including comprehensive scientific literature review, data migration from analogue compounds or through preclinical and clinical studies. Nevertheless, the need to generate data by means of other methods than animal tests is widely acknowledged and has led to an overall development of computational…

Environmental Risk Assessment. ERA reports

In accordance with Article 8(3) of Directive 2001/83/EC, an application for a marketing authorisation for a medicinal product for human use must be accompanied by an Environmental Risk Assessment (ERA). This assessment should be performed according to the European Medicines Agency, following the procedure described in Guideline on the Environmental Risk Assessment of Medicinal Products…