Drug Discovery to Drug Approval through Clinical Trials.
Author (s): Anjan Kumar Mahapatra, Ghanshyam Panigrahi
P.G. Department of Pharmaceutics and P.G. Department of Pharmacology,
Royal College of Pharmacy and Health Sciences, Berhampur-760002, Odisha, India.
The practice of the drug discovery process has been revolutionized with the advancement of newer techniques. Target based drug design is more advantageous, time saving and effective. With the use of combinatorial chemistry and high throughput screening (HTS) techniques, a large number of compounds are synthesized and screened. Quantitative structure activity relationships (QSAR) constitute immense importance in discovering new drug candidate called analogues showing affinity with the target. Preclinical studies in animal determine safety and effectiveness of the drug under controlled environment. Clinical trials, often called “the gold standard” are the most perfect tool for evaluation of the applicability of the clinical research. Clinical trials can be performed, after an application is submitted to competent authority of the concerned country. The competent authority reviews an application submitted to get approval for marketing the drug and approves if satisfied with the quality, safety and efficacy aspects. Though certain aspects of drug approval process are similar among different countries, some differences do occur. To overcome the difficulties due to these differences in various countries, the practice of common technical document (CTD) has been introduced by the international conference on harmonization (ICH). This review shall give an updated insight ofthe title; Drug discovery to drug approval through clinical trials.
Keywords: Drug discovery,clinical trials,common technical,document (CTD),drug approval,regulatory