Toxicological studies as a critical factor for the pharmaceutical development and approval process.
Toxicological studies form the critical part of the drug development process as it involves identification of candidates and their synthesis followed by characterization, validation and optimization. This is further followed by screening and assays for efficiency and therapeutic efficacy. This process development involves preclinical and clinical studies. TOXICOLOGY STUDIES FOR PHARMACEUTICAL DEVELOPMENT AND APPROVAL: It is observed that once a compound shows some therapeutic efficacy it will also exhibit some significance with respect to the investigations done on the basis of drug development process earlier to clinical trials. Toxicological studies are important to understand the order of the development process conducted at various stages to manufacture a medicine that is efficacious, safe and has approved the regulatory requirements and specifications. It is necessary to timely and periodically validate the method development process using the rightful research tools ...