Clinical Trial Characteristics of Consistency Evaluation for Generic Drugs (BE):
Bioequivalence studies could be considered the most critical part of the clinical development program for generics.Although there is every possibility that your developed formulation is near perfect, it is no guarantee for a successful BE study and thus an undesired end-product. In order to reduce the risks associated with your generic assets in development,you need a solid and cost-effective program to determine this to prevent spending a substantial budget at a later stage.
Advantages of Tigermed:
To ensure cost-effectiveness, Tigermed has developed high-quality one-stop BE tests for consistency evaluation of your generic drugs.Our BE team has a strong technical affinity and extensive experience in generics development which they implement to provide you with medical writing, audit management, sample testing, data management, and statistical analysis.
Clinical centers that are widely distributed and have been established jointly with well-known clinical institutions assure the quality of our clinical development programs. Furthermore, the Sino-US unified quality system has been implemented and our operations are completely in accordance with US FDA and EU GLP/GMP/GCP standards. Thanks to this sound quality management, we have already successfully passed over 30 US FDA on-site audits and more frequently on customer sites.
Our clinical trial experience includes but is not limited to the following indications:
? Coronary heart disease
? Hepatitis B
? Prostate cancer
? Prostatic hyperplasia
? Female contraception