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BioAvailability & BioEquivalence

The cost of healthcare has been escalating since the last two decades globally and this has prompted efforts in most countries to reduce costs.

 

As the price of branded medical treatments are quite high and not affordable to the all society; it is evident that they must be brought down.

 

The concept of Bio-availability (BA) and Bio-equivalence (BE) has been accepted by the pharmaceutical industry for more than 20 years and is applied to both old and new products. Thus, thousands of high quality drugs are available at reduced costs at all parts across the globe. These studies help to establish the drug safety and efficacy in comparison to the branded product.

 

Establishment of BE is not a simple task and it can be done through several approaches which must be following target market and specific regulatory authority requirements. For example, certain guidelines from USFDA including 21 CFR Part 320 apply to establishment of BA BE for Oral Dosage Forms and non-oral administration for the drug products like trans-dermal delivery systems, Rectal and Nasal Drug Products.

 

Focused and Targeted Delivery…

 

IRI CRO clinical operations teams has a dedicated study team which conducts exclusively BA BE studies within the associated IRI CRO premises or at identified and approved strategic partners’ locations.

 

The BA BE clinical operations study team is well experienced to handle all aspects of a BA BE Studies, right from the protocol development, design, training, subject dosing, collection of clinical samples and sample analysis at the GLP Approved laboratories along with the statistical analysis and preparation of the final report. The IRI CRO study team caters to the seamless execution of the study timelines with its efficient and cost effective project management.