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Pharmaceutical Consultants

IVIVC Evaluation

IVIVC  Evaluation

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 solid dosages.

In generic product development major cost is of clinical studies i.e. more than 50% of total development cost. So, it is desirable to develop first time right formulation to pass bio-equivalence study and this can be achieved by evaluation of in-vitro study data and correlating it with available in-vivo data.

This evaluation of IVIVC 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 IVIVC evaluation service is provided to pharmaceutical companies by experts having wide experience in evaluating in-vitro in-vivo data and interpreting it to develop correlation.

IVIVC evaluation is done based on the in-vitro data generated by research team of the 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, sponsor/company is suggested i.e. whether to go ahead or modify the formulation.

Evaluation of IVIVC reduces the risk of bio-equivalence study substantially, therefore it is recommended.

We offer IVIVC evaluation for various dosage forms and specialized for Dry Powder Inhalers (DPI).

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