JOINT PROJECTS
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University of Maryland Project
IVIVC-PIVOTAL Biostudies
International Journal Drug Development
 
Bioequivalency Testing IVIVC - Do's and Don'ts - TIPS AND TRAPS Guidelines and significant University of Maryland publications this year.

The University of Maryland and IAGIM have joined forces in preparing an A - Z on what to do, and what not to do - in a PIVOTAL IVIVC Biostudy.

This is a major Joint Venture Program that should run for a full year.

Data will be available to the public on LIG web sites as well as the IAGIM New Site opening in March/April at - IAGIM.org

SCOPE of IVIVC Publications - (University of Maryland)

Nine to ten IVIVC guides/manuscripts over the next 12 months on the following topics for the IVIVC Series -
1. In Vitro-In Vivo Correlation Definitions and Regulatory Guidances.
2. In Vitro-In Vivo Correlation with Metoprolol Extended Release Tablets Using Two Different Releasing Formulations:- An Internal Validation Evaluation.
3. Systematic method for the development and validation of an IVIVC with relevant examples.
4. Development of an IVIVC for a Class I agent Metoprolol tartrate using two formulations.
5. The role of stereoisomerisms in IVIVC development.
6. The application of IVIVC for immediate release products, a Class I and III drug example.
7. The role of mathematical modeling in IVIVC development, Case Report Using a Non-linear relationship between FRA and FRD.
8. The role of pharmacokinetic variability in individual IVIVC in product development.
   

Both the Journal of Generic Drugs and Journal of Drug Development will highlight the full series of UM articles, and IVIVC results with added checklists, Flowcharts and Do's & Don'ts.

For more information
All reviews and publications as well guidelines flowcharts and tips & traps will be published in the following journals as well as being places in the IAGIM Online Center.
International Journal Generic Drugs
International Journal Drug Development
 

 

University of Maryland Project
BBB Project
Blood Brain Barrier Evaluation of CNS Agents

Evaluate the BBB potential of your compounds with the.
Pharmacokinetics-Biopharmaceutics Laboratory (PBL)
University of Maryland ,Baltimore.


The PBL offer the following products and services:
Screening of CNS compounds across the BBB (in vitro models).
Identification of cellular mechanisms affecting transport across the BBB.
Pharmacokinetic analysis of brain distribution (in vivo models).
In vitro-In vivo Correlations (IVIVC).
Analytical analysis of compounds (UV-HPLC, LC/MS)
Pharmacokinetic modelling.

FOR MORE INFORMATION

1) e-mail PBL at : neddingto@rx.umaryland.edu

2) e-mail locum

University of Maryland, Baltimore,
Pharmacokinetics-Biopharmaceutics Laboratory ( PBL)
100 Penn Street
Baltimore, MD 21201, USA

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