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…

Interview with Paulino Alonso: ICHQ3D on Elemental impurities

ICHQ3D implementation involves a risk analysis to design strategies to control elemental impurities in drugs for human use, accountability for which lies fully with the owners of the marketing authorisation. The deadline to implement this guideline for elemental impurities expires at the end of 2017.   In this interview, Paulino Alonso, Azierta’s Toxicology team responsible…

Phases in the evaluation of the occupational exposure to chemical substance/API. Phase 3: Quantitative evaluation of the risk of inhalation.

After the banding control has been established along with the strategies to be followed, it is necessary to carry out a control of the exposure and establish corrective measures (depending on the “Risk Factors” and their priority). A quantitative evaluation of the exposure must be done to check the corrective measures. To this end, we…

Phases in the evaluation of the occupational exposure to a chemical substance/API. Phase 2: Occupational exposure band-technical measures

After calculating the OEL and categorising the substance, the Occupational Exposure Band (OEB) must be obtained that will define the technical and organisational measures to be taken into account. Control banding is defined by the NIOSH as a process in which a single technological control measure (such as general ventilation or containment) is applied to…