Intertek provides comprehensive Comparator Studies for drug products.
Intertek provides services for comparator development and validation, and offers comparator studies in the USA and in Europe. Comparators are typically existing marketed drug products, or new drugs in development (including placebo versions), that are compared with another (usually similar) product in the same therapeutic class in order to assess relative bioequivalence, efficacy and safety.
Comparator studies benchmark and provide points of reference for clinical trials, as well as demonstrating the drug of interest is equivalent or superior to the marketed product in the same therapeutic class. Intertek provides blinded products via over encapsulation or de-inking, method development and validation for assay, dissolution and moisture testing along with facilities for release and stability testing.
Comparator Studies services include:
- Method development and method validation
- Release testing
- Stability storage and testing
- Dissolution and assay method
- DEA schedule I, II, III, IV and V licenses
- For compendial and propriety products
- Dissolution testing (Apparatus I, II and IV)
- Reference standards
Intertek is DEA licensed (Schedule I-V) with the ability to handle controlled substances (generic and proprietary).
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Request more information to see how Intertek can help your organization with Comparator Studies.