SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for preparing preclinical study reports. This SOP ensures that study reports are accurately and comprehensively prepared, following the data analysis and interpretation of preclinical studies. The preparation of these reports is essential to document the study findings, support regulatory submissions, and provide a clear record of the study’s execution and outcomes.
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The purpose of this Standard Operating Procedure (SOP) is to outline the process for the ethical review and approval of preclinical studies. This SOP ensures that all preclinical studies involving animals are conducted in compliance with ethical standards, regulatory guidelines, and animal welfare laws. It provides guidance on obtaining ethical review and approval for the study protocol before commencing any animal research activities, thus safeguarding the rights of the animals used in research.
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The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for managing and archiving preclinical study data. Proper data management ensures that study data is accurate, complete, and accessible for future reference. Archiving study data in compliance with Good Laboratory Practice (GLP) standards is essential for maintaining data integrity, ensuring compliance with regulatory requirements, and supporting the reproducibility and transparency of preclinical studies.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting preclinical studies in compliance with Good Laboratory Practice (GLP). GLP is a set of principles that ensures the quality, integrity, and reproducibility of data in non-clinical laboratory studies. This SOP outlines the requirements for study planning, execution, documentation, and reporting to ensure that preclinical studies are conducted according to GLP standards.
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The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for bioanalytical sample analysis and the subsequent reporting of results. This process is critical in ensuring that the data generated from bioanalytical testing are accurate, reliable, and suitable for pharmacokinetic studies, efficacy evaluations, and safety assessments in preclinical and clinical trials. The SOP provides detailed instructions for handling bioanalytical samples, performing the analysis, interpreting the results, and compiling the findings into comprehensive reports for further regulatory review.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for preparing bioanalytical methods used to quantify and analyze the concentration of drug candidates and their metabolites in biological samples during preclinical studies. Bioanalytical methods are crucial for determining pharmacokinetic profiles, assessing the bioavailability of compounds, and supporting the evaluation of drug safety and efficacy. This SOP ensures the development and validation of bioanalytical methods that are accurate, reliable, and suitable for the intended study.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting cardiotoxicity testing in preclinical animal models. Cardiotoxicity testing is essential for assessing the potential adverse effects of drug candidates on the heart, including arrhythmias, heart failure, and other cardiovascular issues. This SOP ensures that cardiotoxicity studies are performed in a standardized and reproducible manner, providing valuable data to support the safety of drug candidates before clinical trials.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for evaluating potential drug-drug interactions (DDIs) in preclinical models. Understanding DDIs is crucial to assess the safety, efficacy, and pharmacokinetic behavior of drug candidates, particularly in combination therapies. This SOP ensures standardized methods for studying DDIs, providing reliable data on the effects of concurrent drug administration on absorption, distribution, metabolism, and excretion (ADME) properties of the drugs.
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The purpose of this Standard Operating Procedure (SOP) is to define the methodology for establishing dose-response curves in preclinical studies. Dose-response curves are essential in determining the relationship between the dose of a drug candidate and its pharmacological effect. This SOP ensures that dose-response studies are conducted in a standardized manner, providing reliable data to help identify the effective dose range, therapeutic window, and potential toxicities of a compound.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting behavioral studies in animal models. Behavioral studies are essential in preclinical research to evaluate the impact of drug candidates or experimental treatments on cognitive function, emotional responses, and motor behavior. This SOP ensures that behavioral studies are conducted systematically, ethically, and in compliance with regulatory standards, providing reliable data on the effects of treatments on animal behavior.
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