Abstract
Once the Preclinical Candidate is notified, the preclinical development program consists of various activities to support the Investigational New Drug (IND) filing. Data from pivotal safety pharmacology and toxicology studies is a critical component of IND application. Apart from safety pharmacology and toxicology studies, this chapter also briefly covers pharmacokinetics and metabolism studies as well as toxicokinetics and tissue distribution studies. Information on the absorption, distribution, metabolism, and excretion of the drug in animal species, if known, is required to be included in the IND application. This helps to determine the dose levels and frequency of administration for the safety pharmacology and toxicology studies as well as interpretation of the findings from these studies. Safety pharmacology studies are done to identify, evaluate, and investigate the undesirable pharmacodynamic properties of the compound that may have relevance to its human safety. These include essential, follow-up, and supplemental safety pharmacology studies. Toxicology studies done in animal species are aimed at ensuring the safety of a compound for human administration. The no observed adverse effect level determined in the chronic toxicity studies gives critical information for calculation of first in man dose. Apart from systemic toxicology studies, data from many other toxicology studies is required to be included in IND application. These include reproductive toxicity, local toxicity, mutagenicity and genotoxicity, carcinogenicity studies, etc. The requirement of safety pharmacology and toxicology data depends on the phase of clinical development and therefore not all preclinical studies are required to be completed prior to initiation of human trials.
Published Version
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