In vitro - in vivo correlation and biopharmaceutical classification system (bcs ): A review
暂无分享,去创建一个
In vitro dissolution has been extensively used as a quality control tool for solid oral dosage forms. In several cases, however, it is not known w hether one can predict the in vivo performance of these products from in vitro dissolu tion data. In an effort to minimize unnecessary human testing, investigations of in vit ro / in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are i ncreasingly becoming an integral part of extended release (ER) drug product development. Thi s increased activity in developing IVIVCs indicates the value of IVIVCs to the pharmaceutical industry. Because of the scientific interest and the associated utility of IVIVC as a valuable tthe US Food and Drug Administration has published a Guidance in September 1997, entitled Ex tended Release Oral Dosage Forms: Development, rapidity in Drug development can be ac hieved by researchers on finding a mathematical link between bioavailability and disso lution testing which leads to the concept of in vitro -in vivo correlation (IVIVC). IVIVC is a m athematical model that can be used to estimate in vivo behavior from its in vitro performance. Amo ng all the five levels of correlation, Level A correlation is widely accepted by the regulatory ag encies. Biopharmaceutical Classification System (BCS) explains the suitability of IVIVC. Dis solution method design plays a pivotal role in the estimation of correlations. Applications of IVI VC ranges from drug and product development, their scale up and post approval chang es. Hence, IVIVC should be considered as an important tool in drug development.
[1] R. Schoenwald,et al. A bioavailability comparison in rabbits of two steroids formulated as high-viscosity gels and reference aqueous preparations. , 1979, Investigative ophthalmology & visual science.