PDx-IVIVC™ Now Available
TOOLS FOR IN VITRO - IN VIVO CORRELATION |
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| Within one web application: |
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Explore and develop IVIVC using comprehensive, sophisticated modeling tools |
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Optimize formulation development |
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Understand and apply IVIVC, SUPAC, and Biowaiver principles and guidances |
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| 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. |
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| Features v1.0 |
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IVIVC Model Development Two-Stage Approach |
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External Predictability of an IVIVC Model |
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Prediction of In Vivo Characteristics from In Vitro Data |
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| Future Features |
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Exploration of In Vitro and In Vivo Relationships |
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Level C IVIVC Model |
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Multiple Level C IVIVC Model |
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Determination of Dissolution Specifications |
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IVIVC and Biowaiver Regulatory Guidance |
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| System Requirements |
| Licensing |
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| Features v1.0 |
| IVIVC Model Development Two-Stage Approach |
| Perform these processes in one integrated software application: |
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Deconvolution, where the fraction or percentage of drug absorbed is determined. |
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Correlate the in vivo fraction or percentage absorbed data to the in vitro fraction or percentage dissolved data. |
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Develop a linear IVIVC model. Incorporate scaling into the model if needed. |
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Evaluate the internal and external predictability of the developed IVIVC model. |
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| Incorporate any or all of the following using this flexible modeling tool: |
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Difference in IR and ER formulations |
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Difference in bioavailability for IR and ER dosage forms |
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Time scaling |
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Time shifting |
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Limit on GI absorption duration |
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| 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. |
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| 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. |
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| Future Features |
| Exploration of In Vitro and In Vivo Relationships |
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Utilize this capability early in the development process of the compound/formulation |
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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 |
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| 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). |
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| 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. |
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| 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. |
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| 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. |
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