01

Challenge

Can we establish effective IVIVC and skip pilot study?

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Solution

IVIVC tool is a surrogate for in-vivo bioavailability and with better understanding about the product characteristics and correct statistical method correlation, one can predict the in-vivo behaviour of the formulation.   The main challenges that lie in establishing a correct IVIVC are inter subject variability related to pH, drug residence time in GI tract and viscosity effect of food which influences drug release and ultimately drug absorption. With due consideration of above factors using correct tool and having thorough understanding of formulation and bioequivalence, correct IVIVC prediction is possible.   Pharmadesk has performed multiple IVIVC and has in house formulation and bio experts.   The solution to this challenge is address under Augment service.

To overcome this challenge, we have a service called "Augment" to know more about "Augment" features, please click below...

augment

Solution to bioequivalence concerns

Resolving all the BE related questions which are unanswered and beyond the scope of CRO!

Augment also Provides Solutions to Following Business Challenges

02

Challenge

In case of a fasting and fed study which study do we need to perform first?

03

Challenge

Can we use Two Stage or Add on Design instead of repeating study on higher sample size?