Comparator Studies

Expert comparator studies to benchmark relative bioequivalence efficacy and safety of similar marketed drug products

Comparator studies and blind comparator stability testing demonstrate whether a pharmaceutical product is equivalent or superior to the marketed drug product in the same therapeutic class. Comparator studies also provide points of reference for clinical trials, helping to assess relative bioequivalence, efficacy and safety. Comparators are existing marketed drug products, or new drugs in development (including placebo versions). The comparative dissolution rate of the active pharmaceutical ingredient (API) from a new solid oral dosage form, in particular, is an important regulatory consideration for formulation development. 

As your outsourcing partner for comparator and blind comparator stability studies, we offer cost effective yet comprehensive expertise to help you to compare your innovator drug against an existing medication. Our teams can provide blinded products via over-encapsulation or de-inking, assay, method development and validation, in vitro comparative dissolution (Apparatus I, II and IV) in media of different pH, such as simulated gastric or intestinal fluids, moisture testing, stability storage, release testing and reference standard programs.  

Our GMP stability facilities run blind comparator stability studies to store your innovator drug over time under a range of different temperatures to verify its comparative efficacy and stability. Intertek's laboratories hold controlled drug licences, for example, Drug Enforcement Administration (DEA) schedule I, II, III, IV and V licenses. 

Our experts provide comprehensive comparator studies from GMP compliant laboratories in North America and Europe, helping you to achieve a competitive edge in the global marketplace.

Comparator studies include:

 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
AMER
+1 908 534 4445 x600
EMEA UK:
+44 161 721 5247
Switzerland:
+41 61 686 4800