Begins
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January 27, 2012
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Ends
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January 29, 2012
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City
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Description
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Objective of present workshop is to address one of the
most important topics in drug product deve-lopment & bioequivalence and
that is IVIVC.
During formulation development, formulation optimi-zation may require altering formulation composition, manufacturing, equipment and batch sizes. Normally, these types of changes require bioavailability studies to be performed to ensure that the “new” formulation displayed statistically similar in-vivo behavior as the “previously developed and accepted” formulation. This requirement can delay the marketing of the new formulation and add time and cost to the process. In vitro-in vivo correlation (IVIVC) has been defined by the Food and Drug Administration (FDA) as “a predictive mathematical model describing the relationship between an in-vitro property of a dos-age form and an in-vivo response”. In view of this, the in-vitro property, drug dissolution can be used to predict the in-vivo plasma drug concentration profile The present workshop will address IVIVC basics, correlation levels, A, B, C etc., bio-waivers based on IVIVC, other details and examples to make the participants fully conversant to the technique of working out IVIVC correlation. For more Details: Click Here |
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