Watson LIMS Integration The new Watson LIMS Plug-in in Phoenix Connect 1.4 allows the user to connect to a Watson LIMS database and to extract study data and to create an analysis-ready worksheet. To better serve our customers’ needs, the newest version of Phoenix Connect 1.4 will have Watson LIMS Integration and improved support for the clinical study data standard, SDTM (Study Data Tabulation Model), and the preclinical data standard, SEND (Standard for Exchange of Nonclinical Data) as specified by the Clinical Data Interchange Standards Consortium (CDISC). In this webinar, Dr Venkateswari Muthukrishnan and Dr Nikunjkumar Patel presented a case study that illustrates the differences between conventional and mechanistic IVIVC and provide guidance on tools that support each approach. Physiologically-based pharmacokinetic (PBPK), mechanistic IVIVC is an emerging approach that separately accounts for the multiple mechanisms that determine a drug's in vivo input rate considering transit time, gut wall permeability, gut wall metabolism, and hepatic first-pass metabolism from dissolution rate. However, there are also cases where conventional models are not useful for developing correlations.
Clearly, there have been many instances of successful development and use of conventional IVIVC models. Assist in quality control during manufacturing and selecting appropriate formulations.Ĭonventional IVIVC uses deconvolution methods such as Wagner Nelson, Loo-Riegelman and numerical deconvolution to estimate the rate of input of drug into the systemic circulation from observed plasma drug concentrations of the oral formulation with the use of the unit impulse response (UIR). Support and/or validate the use of dissolution methods and specifications. Serve as a surrogate for human bioequivalence (BE) studies.
Drug developers frequently use in vitro-in vivo correlations (IVIVCs) to: