Dr Girish Jain, Pharma Consultant, Cochlea Pharma, speaking about in-vitro-in-vivo correlation while giving his presentation, also brought up its various types.
He said, “It is a predictive mathematical model describing the relationship between an in-vitro property of a dosage form (rate or extent of drug dissolution) and a relevant in-vivo response (plasma drug concentration or amount of drug absorbed).”
He spoke about methods for development of correlations. There are two methods (model-dependent including Wagner Nelson and Loo Reigelmann) and (model-independent including numerical deconvolution) and physiological-based (mechanistic deconvolution).
Later, he said that IVIVC should be demonstrated consistently with two or more formulations with different release rates resulting in corresponding differences in in-vivo absorption profiles. Formulations should be compared in a single study with crossover design. In addition, he said that IVIVCs are developed in fasted state unless the drug is not tolerated in fasted state and in-vitro dissolution methodology should adequately discriminate among formulations.
He said, “For poorly soluble drugs, addition of surfactants may be appropriate. The dissolution profile of at least 12 individual dosage units from each lot should be determined. The same dissolution method should be used for different formulations.”
He also spoke on regulatory applications like waiver of required in-vivo BA/BE studies, wider than standard in-vitro release acceptance criteria and evidence for biorelevant and discriminating dissolution method.
He then discussed some of the common reasons for non-acceptance of IVIVC. “Use of different formulations, each from a different manufacturer to develop IVIVC, is not acceptable. Internal and external predictabilities are not evaluated,” he notified, along with mentioning a few other reasons.
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