PRODUCTS: PDx-IVIVC® Now Available
TOOLS FOR IN VITRO - IN VIVO CORRELATION


Within one web application:
Explore and develop IVIVC using comprehensive, sophisticated modeling tools
Optimize formulation development
Understand and apply IVIVC, SUPAC, and Biowaiver principles and guidances

PDx-IVIVC
is a comprehensive In Vitro - In Vivo Correlation toolset, bringing together the very latest tools and approaches. User-friendly screens provide step-by-step instructions and information for each process. As a software application hosted by GloboMax, users are up and running within minutes of registration.



Features v1.0
IVIVC Model Development Two-Stage Approach
External Predictability of an IVIVC Model
Prediction of In Vivo Characteristics from In Vitro Data



Future Features
Exploration of In Vitro and In Vivo Relationships
Level C IVIVC Model
Multiple Level C IVIVC Model
Determination of Dissolution Specifications
IVIVC and Biowaiver Regulatory Guidance



System Requirements
PDx-IVIVC supports the following browser versions and settings:
Microsoft Internet Explorer® 5.0+
Cookies, JavaScript, and ASP enabled

PDx-IVIVC
is currently available as a software web application hosted by GloboMax.
Users access the application via the Internet, eliminate the setup time and investment associated with premises-based solutions.
With Internet access, a current web browser, a valid application account name and password, be up and running within minutes of processing the user fee.

Contact GloboMax for special implementation requests.



Licensing
At this time, ICON Development Solutions is currently evaluating future development support efforts for PDx-IVIVC. No additional licenses or renewals will be issued during this evaluation period. Alternatively, in order to meet your immediate needs, our group of expert PK scientists is available and happy to provide consultation involving IVIVC as well as any other PK related service.




Features v1.0
IVIVC Model Development Two-Stage Approach
Perform these processes in one integrated software application:
Deconvolution, where the fraction or percentage of drug absorbed is determined.
Correlate the in vivo fraction or percentage absorbed data to the in vitro fraction or percentage dissolved data.
Develop a linear IVIVC model. Incorporate scaling into the model if needed.
Evaluate the internal and external predictability of the developed IVIVC model.

Incorporate any or all of the following using this flexible modeling tool:
Difference in IR and ER formulations
Difference in bioavailability for IR and ER dosage forms
Time scaling
Time shifting
Limit on GI absorption duration



External Predictability of an IVIVC Model
Evaluate the predictability of the IVIVC Model, using one or more additional test data sets that differ from those used to define the correlation. Compare results with regulatory criteria.



Prediction of In Vivo Characteristics from In Vitro Data
Predict In Vivo concentration-time profiles and their associated bioavailability parameters using a pre-existing IVIVC model and in vitro dissolution data. Provide support for a biowaiver or SUPAC submission or to aid in the formulation selection process before clinical studies.



Future Features
Exploration of In Vitro and In Vivo Relationships
Utilize this capability early in the development process of the compound/formulation
Optimize formulation development/selection decisions using simulations of the in vivo profiles and associated bioequivalence parameters, based upon either actual or hypothetical in vitro data.



Level C IVIVC Model
Establish a single point relationship between a dissolution parameter, for example, percent dissoved in 4 hours and a pharmacokinetic parameter (e.g., AUC, Cmax, Tmax).



Multiple Level C IVIVC Model
Relate one or several pharmacokinetic parameters of interest to the amount of drug dissolved at several time oints of the dissolution profile.



Determination of Dissolution Specifications
Use PDx-IVIVC to add in vivo relevance to in vitro dissolution specifications, beyond batch-to-batch quality control. In this approach, the in vitro dissolution test becomes a meaningful predictor of in vivo performance of the formuation, and dissolution specifications may be used to minimize the possibility of releasing lots that would be different in in vivo performance.



IVIVC and Biowaiver Regulatory Guidance
Transition from scientific analyses to regulatory strategy within the same toolset. Review issues and methods presented in regulatory guidances related to IVIVC, biowaivers, and SUPAC. In addition, review case studies that demonstrate the application of an IVIVC to support biowaivers and SUPAC submissions.