NOVEL CONSULTANTS

In-Vitro data Evaluation to Ensure Success of Bio-equivalence Study in First-go

• In today’s scenario, it is important for pharmaceutical companies who are mainly in generic business to have cost effective development of generic formulations especially Oral dosages and Nasal Products.

• In generic product development major cost is of clinical studies i.e. more than 60% of total development cost. So, it is desirable to develop first time right formulation to pass Bio-equivalence study in First-go and this can be achieved by evaluation of in-vitro study data and correlating it with available in-vivo data.

• This evaluation of In-Vitro data becomes difficult for BCS class II, III & IV molecules and it is further complicated if the formulation to be developed is modified release or alternate route of administration are involved like vaginal route.

• So, here In-Vitro data evaluation service is provided on consultancy basis to pharmaceutical companies by the experts having wide experience in evaluating in-vitro data in relation with available clinical data.

• Correlation is done based on the in-vitro data generated by research team of company and same is evaluated with reference to available clinical data on public domain or clinical data of pilot study is used to establish correlation. Based on inference of evaluation company is suggested i.e. whether to go ahead or modify the formulation.

• Evaluation of in-vitro data & establishing correlation with clinical data reduces the risk of bio-equivalence study substantially, therefore it is recommended.

• We offer this consultancy service for various dosage forms. We are specialized for Dry powder inhalers (DPI).