What is the current regulatory approval process for starting a new phase III clinical trial in India?
Answers from top 5 papers
More filters
Papers (5) | Insight |
---|---|
20 Citations | Investigators should increase consideration of the potential impact on phase III trials to optimally select the proper trial design prior to phase II study implementation. |
104 Citations | A greater investment in phase I and II drug trials may be required to provide the information necessary for phase III planning. |
29 Citations | In summary, cross-over trials remain a potentially valuable research tool in the development of new medicines at all stages including phase III. |
15 Citations | AIMS For ethical and economic reasons, interim analysis of phase III clinical trials is essential. |
The choice of meta-analysis methods can influence the decision about whether a trial should proceed to Phase III and thus need to be clearly documented and investigated whenever a Phase II meta-analysis is performed. |
Related Questions
What is needed for new fda drug approval?4 answersFor the approval of a new drug by the U.S. Food and Drug Administration (FDA), clinical trial evidence demonstrating efficacy with 2.5% statistical significance is required, although regulatory discretion is often applied. Factors such as disease severity, prevalence, and availability of existing therapies are qualitatively considered but not systematically incorporated into approval decisions. The FDA's drug approval process involves a queueing framework that considers disease-specific factors and obsolescence, with optimal policies relaxing approval standards for diseases with specific characteristics. The FDA's review process includes a thorough evaluation of the drug substance, chemical processes, analytical methods, and impurities, as outlined in the Common Technical Document.
How many RNA drugs are approved?8 answers
How much do you get paid for clinical trials in India?1 answers
In which phase of clinical trials post marketing surveillance of drug is carried out?5 answers
Which phase of clinical trial is carried out after a new drug is marketed?6 answers
Who gives permission for clinical trials?3 answers