We review, provide guidance, and assist in the compilation of clinical pharmacology and biopharmaceutics part of the regulatory dossiers. Some of the steps of our approach include:
The pharmaceutical assessment includes the chemistry and physical-chemical properties of the drug substance and the formulation of the drug product as they relate to clinical pharmacology and biopharmaceutics review; the proposed mechanism of action, the proposed dosage(s), and route(s) of administration.
The design features of the clinical pharmacology and clinical studies used to support dosing or use claims? The characteristics of the exposure-response relationships (dose-response, concentration-response) for efficacy?
The intrinsic factors (age, gender, race, weight, height, disease, genetic polymorphism, pregnancy, and organ dysfunction) influence exposure and/or response. Assessment and guidance on their variability and the groups studied, impact on the elderly, renal, hepatic Impairment, impact on pregnancy and lactation. Our review approach is comprehensive and incorporates practically all areas of concern and assessment of the need for data. Please feel free to connect if you have any particular concerns or need support.
