In Vitro/In Vivo correlations and relationships
There is a growing expectation among regulatory agencies that companies develop drug formulations on the basis of the best available scientific information. One accepted way to demonstrate this is to establish and validate a relationship between drug dissolution and the rate and extent of drug absorption.
Developing and validating a predictive IVIVC is a large and expensive commitment. If successful, an IVIVC may offer several advantages that easily offset the initial cost and effort of obtaining it. However, not all drugs are suitable candidates for in vitro in vivo relationships. If a drug is not a suitable candidate for an IVIVC, then the effort and expense of trying to obtain it cannot be recovered.
Vista Biopharmaceutics will determine if a drug is a suitable candidate for an IVIVC relationship and, if so, offer guidance for design of the required clinical study and support for establishing and validating the relationship.