in vitro-in vivo correlation (IVIVC), Biowaivers & Statistical aspects of Bioequivalence in Drug Pro (ivivc, Biowaivers, B)
|Event Date/Time: Jan 27, 2012||End Date/Time: Jan 29, 2012|
|Registration Date: Jan 15, 2012|
|Early Registration Date: Nov 01, 2011|
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 â€œnewâ€ formulation displayed statistically similar in-vivo behavior as the â€œpreviously developed and acceptedâ€ 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 â€œa predictive mathematical model describing the relationship between an in-vitro property of a dos-age form and an in-vivo responseâ€.
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.
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 will be discussed in details. Participants will be calculating sample size using excel during the workshop. Biostatistical aspects for two way crossover design will be covered in detail including examples. In view of several highly variable drugsâ€™ bioequivalence studies being carried out in various CROs, all minute aspects of statistical issues to cover Reference scaling will be discussed 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.
This workshop is useful for
ïƒ˜ Principal instigators, Pharmacologists & senior bio-analysts working in Bioequivalence CROs
ïƒ˜ Biostatisticians working on BA/BE studies in CROs as well as in Pharma R&D canters
ïƒ˜ All those involves in generic formulation development (F&D) for ANDA and other submissions
ïƒ˜ M. Pharm students looking forward to career in F&D and BA/BE
ïƒ˜ Any other person related to BA/BE interested to learn IVIVC