Flexibility and Strong Process-driven Planning Overcomes Regulatory Speed-bumps
Sponsors consider Russia as an attractive study venue due to the countries higher enrollment and patient retention rates and lower overall cost. This paper outlines the regulatory requirements for obtaining regulatory approval for clinical studies and addresses certain practical aspects of regulatory submissions in Russia.
The number of patients required in a trial is one of the cornerstones of the trial design. This number is calculated by using statistics, but the validity of any estimated number is totally dependent on certain assumptions. So before the estimates can begin, there are somekey questions that need to asked and answered. Read more in this Clinical Endpoint ANDA Program Optimization White Paper Series
Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two
For Dermal Semisolid Clinical Studies […]
Clinical Endpoint ANDA Program Optimization White Paper Series: Optimizing the Amount of Investigational Materials in ANDA Studies – Part One
This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry.