Sotax India and Pharma Edge Centre will be organising a three-day workshop on in vitro-in vivo correlation (IVIVC), one of the important topics of generics drug product development and bioequivalence, in Mumbai from  January 27 to 29, 2012. The 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.   

The workshop will also cover statistical aspects of BA/BE studies, introduction to basic concepts of biostatistics with examples followed by the most important biostatistical concepts such as sample size calculation etc. It will also showcase and discuss biostatistical aspects for two way crossover design and reference scaling in detail.  The presentations are designed using simple examples to make sure each and every participant, a biostatistician or a non-statistician will understand the basics.  The examples will be worked out by the participants themselves to get rid of fear of evaluating statistical parameters in a biostudy.

The 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 dosage 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.

A good correlation is a tool for predicting in vivo results based on in vitro data.  The main purpose of carrying out an IVIVC is to utilise in vitro dissolution profiles as a surrogate for in vivo bioequivalence and to support bio-waivers.  IVIVC also allows optimisation of a particular formulation which may require fewest possible pilot studies in man.  The knowledge obtained from IVIVC can be used to fix dissolution acceptance criteria.

IVIVC understanding helps to reduce the number of bioequivalence studies required as well as during scale-up and post-approval changes. India is emerging as a major player in developing generic drug products. Understanding of IVIVC will help the F&D to develop better formulations in a minimum possible time.  Case studies worked out by participants themselves will provide confidence to use IVIVC regularly.  

This workshop is useful for principal instigators, pharmacologists and  senior bio-analysts working in bioequivalence CROs, as well as in Pharma R&D canters. It is also focused to benefit all those involves in generic formulation development (F&D) for ANDA and other submissions, M Pharm students looking forward to career in F&D and BA/BE and any other person related to BA/BE interested to learn IVIVC.

For details and registration, contact Amol Yande, sales manager, Sotax India Mobile: 9867644590