SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for ensuring the quality of data generated during preclinical studies. Data quality is crucial for making informed decisions during drug development, ensuring regulatory compliance, and maintaining scientific integrity. This SOP ensures that data generated in preclinical studies are accurate, reproducible, and compliant with Good Laboratory Practice (GLP) standards, providing a solid foundation for regulatory submissions and clinical development.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for analyzing protein binding in drug development. Protein binding is a critical pharmacokinetic property that influences the distribution, metabolism, and elimination of a drug. This SOP ensures that protein binding studies are conducted systematically and in compliance with regulatory guidelines, providing accurate and reproducible data that will inform drug dosing, safety, and efficacy evaluations in preclinical and clinical stages.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting phototoxicity testing in preclinical studies. Phototoxicity testing is essential for assessing the potential of a drug or chemical compound to cause harmful effects in tissues when exposed to light, particularly ultraviolet (UV) radiation. This SOP ensures that phototoxicity studies are conducted in compliance with regulatory guidelines and Good Laboratory Practice (GLP) standards, providing valuable data for the safety evaluation of new drug candidates before clinical trials.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for preparing preclinical dossiers required for regulatory submissions. These dossiers include essential data from preclinical studies that demonstrate the safety, pharmacokinetics, and efficacy of a drug candidate. This SOP ensures that all preclinical data are compiled, analyzed, and presented in accordance with regulatory requirements, providing a comprehensive and accurate dossier for submission to regulatory authorities such as the FDA or EMA.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting biodistribution studies. These studies are crucial for assessing the distribution, localization, and concentration of a drug or its metabolites within various tissues and organs after administration in animal models. Biodistribution data are essential for understanding the pharmacokinetics of a drug, evaluating its therapeutic potential, and determining its safety profile before clinical trials. This SOP ensures that biodistribution studies are conducted according to regulatory guidelines and GLP standards, with appropriate documentation and data analysis.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting translational studies that bridge preclinical and clinical phases of drug development. Translational studies aim to apply preclinical findings to clinical settings, thereby improving the prediction of clinical outcomes and optimizing the transition from animal models to human trials. This SOP ensures that translational studies are designed, executed, and documented in accordance with regulatory guidelines, internal protocols, and scientific standards to maximize the relevance and applicability of preclinical data in clinical settings.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for performing pharmacokinetic (PK) and pharmacodynamic (PD) modeling in preclinical studies. PK/PD modeling is essential for understanding the relationship between the drug concentration and its pharmacological effect. This SOP ensures that PK/PD modeling is conducted systematically to predict the drug’s behavior in vivo, optimize dosing regimens, and inform the transition to clinical studies.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting exploratory toxicology studies. These studies aim to evaluate the potential toxic effects of a drug candidate in an early stage of development. Exploratory toxicology studies provide valuable data to assess the safety profile of a compound before progressing to more comprehensive preclinical safety assessments. The data generated in these studies help identify potential risks and guide decisions regarding the drug’s development.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting preclinical safety pharmacology studies. These studies are essential for evaluating the potential effects of a drug candidate on vital organ systems, including the cardiovascular, respiratory, and central nervous systems, to ensure the safety of the drug prior to clinical trials. This SOP ensures that safety pharmacology studies are conducted according to regulatory guidelines and are documented comprehensively for regulatory review.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for integrating preclinical study data into an Investigational New Drug (IND) submission. This SOP ensures that preclinical data is appropriately analyzed, compiled, and presented in the IND application to support the safety, efficacy, and quality of the drug candidate. The goal is to comply with regulatory requirements and facilitate a smooth submission process for the clinical trial authorization.
Click to read the full article.