Current Issue : January-March Volume : 2020 Issue Number : 1 Articles : 3 Articles
A 505(b)(2) is provision to seek the regulatory approval without conducting the studies or taking right of reference for new products. There are three regulatory pathways to get the marketing approval for new products in federal register of drug products; 505 (b)(1)New drug application, 505 (b)(2) Hybrid NDA and 505 (j) for ANDA. 505(b)(2) provision has made to avoid the duplication of study, reduce the development time and cost. Topical drug development is popular now days and most of the companies are diverted to topical formulation development. The topical drug development for 505 (b)(2) is useful for long term business, get exclusive marketing rights and get easy entry into market with branded product. A 505(b)(2) involves the no or minimum nonclinical and clinical studies to prove safety and effectiveness of the new products. The choice of RLD Selection and excipients selection also minimizes the number studies required. In last 5 years on an average USFDA has approved 505(b)(2) products and majority are new dosage forms. Typical examples from different filing strategy are discussed related to Topical and transdermal products....
Clinical trials are conducted in humans, in order to find the suitability of any lead compound or molecule, in human being safe or not. Clinical trials are conducted on various sample size ranging from healthy volunteers as well as patients of any desirable disease. In order to conduct the trials lots of data are collected and analyzed in order to find the suitability of any experimental drug. Quantum computing alongwith Artificial intelligence can help in building the faster and more accurate platform in order to conduct the clinical trials more suitabilly as well as efficiently. The present letter has been written in order to bring to the notice the advantages of development in Quantum computing to the whole process of drug development, and more specifically the clinical trials....
Quantum computing the newly developed concept, will power the computer with super Human powers and capabilities. Pharmacovigilance is the science which is concentrated on activities such as detection, assessment and reporting of adverse drug reactions and adverse events. The present letter has been written in order to emphasize the importance of quantum computing to pharmacovigilance activities. Quantum computing will any way help in improving the every aspect of the pharmacovigilance which will help in boosting the efforts to provide quality health care treatment to the patients and people of the world....
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