Specialists in Bioequivalence Studies and Biowaiver applications

This is an important subject that may well decide the outcome of the application for marketing authorisation of medicinal product submitted whether as a generic to the brand in compliance with requirements of Article 10(1) of the Directive or applying for biowaiver in compliance with requirements of Article 10(3) or Article 10(a) of the directive. Different requirements for modified release than for immediate release or gastro-resistant dosage forms are usually imposed.

The founder of this consultancy firm is in unique position being fully accredited for assessment of these studies based on previous experience in this field supported by Ph.D. degree awarded.

Following are the services provided:

• Review and assessment of the bioequivalence studies comparing the in-vivo performance of the generic product and pharmacokinetic parameters measured versus brand and applicability of the requirements of the relevant guideline.
• Review and assessment of dissolution performance carried out for purpose of biowaiver request usually made for multi-strength product and conditions for applicability.
• Assessment of eligibility of the medicinal product for biowaiver based on the provisions given within the relevant guideline in considering the biopharmaceutical classification system (BCS) grade of the DS and its availability.
• Special interest in the assessment and eligibility of oral solutions for biowaiver and applicability of the provision and requirements of the current guideline in this aspect.