Clinical development of a drug candidate and pharmacological evidence by Darren Wogman
Critically discuss the pharmacological evidence that would be needed to justify clinical development: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describe the aims of preclinical testing in their M3 guidance as “[The characterisation of the] toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility..[and] to characterise potential adverse effects” (ICH, 2009). Non-clinical studies ensure that the Investigational medicinal product (IMP) pharmacokinetic (PK) and pharmacodynamic (PD) properties can be determined. Bioavailability studies, mechanisms of ADME (absorption, distribution, metabolism and elimination), safety pharmacology studies, toxicity studies and the assessment of potential genotoxicity, mutagenicity and carcinogenicity are all critical to carry out (Andrade et al., 2016). The drug half-life reflects the distribution and elimination of the drug and…