{"id":7684,"date":"2024-06-20T10:48:00","date_gmt":"2024-06-20T15:48:00","guid":{"rendered":"https:\/\/labtesting.\/?p=7684"},"modified":"2024-06-20T10:58:18","modified_gmt":"2024-06-20T15:58:18","slug":"key-components-of-ind-study-strategy-planning","status":"publish","type":"post","link":"https:\/\/labtesting.\/2024\/06\/20\/key-components-of-ind-study-strategy-planning\/","title":{"rendered":"Key Components of IND Study Strategy Planning"},"content":{"rendered":"\n
A successful Investigational New Drug (IND) submission requires a comprehensive testing approach. From Drug Metabolism and Pharmacokinetic (DMPK) studies to determine the drug\u2019s behavior within the body, nonclinical toxicology assessments to meticulously examine its safety profile, and Bioanalytical studies to measure drug concentrations in biological samples, the process plays a critical role in drug development.<\/p>\n\n\n\n
These studies shape the regulatory narrative, offering vital insights for subsequent clinical trials and advancing the goal of delivering safe therapeutics to patients. This article explores the components of DMPK, toxicology, and bioanalytical studies.<\/p>\n\n\n\n
Drug Metabolism and Pharmacokinetic (DMPK) studies help understand how a drug metabolizes and behaves in the body. There are five core components that a typical DMPK study includes:<\/p>\n\n\n\n
These five DMPK studies help comprehend the drug’s behavior in humans to guide dosage recommendations and ensure safety in future clinical trials. The studies evaluate the drug’s pharmacokinetic properties, enabling regulators to make informed decisions regarding its suitability for human use.<\/p>\n\n\n\n
Before clinical trials commence, developers must establish the drug’s safety profile through in vivo<\/em> studies and other necessary IND enabling tests<\/a>.<\/p>\n\n\n\n Toxicology studies are essential throughout each clinical phase to assess a drug\u2019s safety, with a final set of tests required for the New Drug Application (NDA). Starting with nonclinical toxicology<\/a> studies is key to a successful clinical process. The specific nonclinical safety assessment program<\/a> varies based on the type of molecule and clinical plan. There are five sets of tests required for nonclinical toxicology, per ICH M3(R2) guidance.<\/a><\/p>\n\n\n\n\n