SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the guidelines and methodology for conducting ex vivo studies using preclinical models. Ex vivo studies play a critical role in evaluating the effects of drug candidates on isolated tissues or organs outside of the living organism. This SOP ensures that the procedures are standardized to obtain reliable, reproducible results while maintaining the ethical treatment of animals and ensuring compliance with regulatory standards.
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The purpose of this Standard Operating Procedure (SOP) is to define the proper handling, care, and ethical treatment of laboratory animals used in preclinical studies. The SOP ensures that animals are handled in a humane, safe, and scientifically appropriate manner during all stages of the study, from transport and housing to experimental procedures. This SOP supports the maintenance of animal welfare and compliance with ethical guidelines and regulatory requirements.
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The purpose of this Standard Operating Procedure (SOP) is to define the processes and responsibilities for managing animal facilities used in preclinical studies. These facilities are essential for ensuring the health and well-being of animals while maintaining high standards for scientific research. The SOP outlines procedures to ensure compliance with animal welfare regulations, proper facility operations, and support for successful preclinical research outcomes.
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The purpose of this Standard Operating Procedure (SOP) is to define the guidelines for the management and operation of animal facilities used in preclinical studies. This includes ensuring that animal welfare is maintained, regulatory standards are met, and proper care is given to animals used in studies. The management of these facilities plays a key role in supporting high-quality and reproducible preclinical research by maintaining appropriate housing, environmental conditions, and ethical standards.
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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 assess the potential adverse effects of a drug candidate on fertility, reproductive health, and offspring development. These studies are essential in identifying potential reproductive risks early in the drug development process, ensuring the safety of the drug candidate before advancing to clinical trials. This SOP ensures that reproductive toxicology studies are conducted following ethical standards, regulatory guidelines, and best practices to generate reliable and reproducible results.
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