Published Paper Details:

The preparation and standardization of drug samples for preclinical toxicological animal studies are crucial steps to ensure compliance with regulatory agencies. This thesis outlines the methodologies employed in preparing, characterizing, and standardizing drug samples for preclinical toxicological evaluations. Emphasis is placed on adherence to guidelines set forth by major regulatory bodies such as the FDA, EMA, and ICH. The study explores various formulation techniques, analytical methods for purity and potency assessment, and the stability testing required to maintain sample integrity. Additionally, the thesis discusses the challenges and solutions associated with scaling laboratory preparations to quantities suitable for animal studies, along with the documentation and reporting standards necessary to meet regulatory expectations. The objective is to provide a comprehensive framework that supports the generation of reliable and reproducible toxicological data, ultimately facilitating the safe progression of drug candidates through the preclinical phase. To assess the content drug in the solution form of the drug, and infer the results, a sample quantitative study on progesterone was carried out experimentally. The prepared progesterone solution does not meet the required % purity criterion, indicating a lack in the sample and solution preparation process. Several key practices can be implemented to promote proper sample and solution preparation in a preclinical laboratory setting. By encouraging ongoing professional development and following national and international guidelines, laboratories can achieve high standards of safety, reliability, and ethics in preclinical studies.