SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to provide a standardized approach for preparing preclinical study protocols. Preclinical study protocols ensure that all aspects of the study, such as design, animal welfare, regulatory compliance, and safety standards, are addressed in a systematic and organized manner. A well-prepared protocol ensures that the study is scientifically valid, reproducible, and compliant with ethical guidelines.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting animal studies for preclinical safety assessments of drug candidates. Animal studies are critical to assess the safety of new drugs, identify potential adverse effects, and determine the safe starting dose for human clinical trials. This SOP ensures that the animal studies are conducted ethically, consistently, and in compliance with regulatory guidelines to provide reliable and reproducible data for safety evaluations.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting metabolic stability testing of drug candidates in preclinical models. Metabolic stability studies are crucial for understanding the drug’s potential for metabolism in the liver and other tissues, providing insights into its bioavailability, half-life, and possible drug-drug interactions. This SOP ensures that metabolic stability studies are conducted consistently and in compliance with regulatory guidelines to obtain accurate and reproducible data.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting tissue distribution studies during preclinical testing. Tissue distribution studies are essential for understanding the distribution of a drug candidate in various tissues and organs of animal models after administration. These studies provide vital information on the drug’s bioavailability, its ability to reach target tissues, and the potential for accumulation in non-target organs, which is crucial for assessing drug safety and efficacy.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting pharmacokinetic (PK) studies in preclinical models. Pharmacokinetics is the study of the absorption, distribution, metabolism, and excretion (ADME) of a drug candidate. This SOP ensures that pharmacokinetic studies are performed systematically to obtain reliable data on the drug’s behavior in the body. These studies are critical for understanding the drug’s bioavailability, half-life, dosing regimen, and potential toxicity, guiding decisions on further development and clinical trial planning.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting reproductive toxicology studies to evaluate the potential effects of a drug candidate on fertility, reproductive health, and offspring development. Reproductive toxicity testing is a critical part of preclinical safety assessment to determine any adverse effects on male and female reproductive systems, as well as on embryo and fetal development. This SOP ensures that reproductive toxicology studies are carried out systematically, following regulatory guidelines and ethical standards, to provide reliable safety data for regulatory submissions.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting genotoxicity testing using the Ames test in drug discovery research. The Ames test is a widely used in vitro assay for detecting potential genetic mutations caused by chemical compounds. This test is essential for identifying mutagenic properties of drug candidates early in the development process, ensuring their safety before progressing to clinical trials. This SOP ensures that the Ames test is performed consistently and in compliance with regulatory standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting chronic toxicity studies in animals during preclinical testing. Chronic toxicity studies are designed to evaluate the long-term effects of a drug candidate following prolonged exposure. These studies provide critical safety data, including potential organ toxicity, carcinogenicity, reproductive toxicity, and other adverse effects that may arise from long-term drug administration. This SOP ensures that chronic toxicity studies are conducted in compliance with regulatory guidelines, ensuring the safety of the drug candidate before clinical trials.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting acute toxicity testing in animals during the preclinical phase of drug discovery. Acute toxicity testing is essential for evaluating the potential harmful effects of a drug candidate after a single dose or multiple doses over a short period. This SOP ensures that the testing is conducted following ethical guidelines, regulatory standards, and best practices to provide reliable and reproducible results.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting in vitro toxicity screening of drug candidates during the preclinical phase of drug discovery. In vitro toxicity screening is essential for identifying potential toxic effects of drug candidates on cells and tissues, providing early-stage safety data to guide the decision-making process in drug development. This SOP ensures that in vitro toxicity studies are conducted systematically and according to established protocols to ensure reliable and reproducible results.
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