Publisher's Synopsis
In the dynamic field of drug discovery and development, non-clinical and pre-clinical studies are the foundation of success. With global relevance, "Methods for Laboratory Studies" is your comprehensive guide, offering vital insights for researchers, educators, and students worldwide. The book begins by highlighting the crucial role of non-clinical studies, conducted with strict adherence to Good Laboratory Practice (GLP) regulations. From experimental animals to diverse therapeutic goals, it ensures the highest safety and compliance standards. Dive deeper into early pre-clinical studies, the compass for Go/No-Go decisions. Here, you'll uncover the core elements of a new drug's journey, from pharmacokinetics to safety profiles, including toxicogenetics. Emphasizing GLP-compliant studies, like repeated dosage toxicity, genotoxicity, and safety pharmacology, it guarantees safe human exposure before human trials. Before entering human trials, meticulous completion of non-clinical and pre-clinical studies establishes a robust foundation for Investigational New Drug (IND) applications. Gain insights into the comprehensive research data package bridging the gap between animal and human trials as you turn the pages. After IND approval, additional GLP tests assess carcinogenicity, genotoxicity, chronic toxicity, and reproductive and developmental toxicity. "Methods for Laboratory Studies" isn't just a textbook; it's your gateway to mastering drug discovery. Whether you're a student, educator, or seasoned researcher, this book provides lucid, essential guidelines, empowering you to shape the future of pharmaceutical science.
