[estiv] FDA Funding: Physiologically Based Absorption/PK Modeling for Non-GI Drugs

From: "Valk, J.B.F. van der (Jan)" <j.vandervalk@xxxxx>
To: "'estiv@xxxxxxxxxxxxx' (estiv@xxxxxxxxxxxxx)" <estiv@xxxxxxxxxxxxx>
Date: Thu, 24 Apr 2014 09:11:27 +0000
From Alttox (www.alttox.org):

Title: Physiologically Based Absorption and Pharmacokinetic Modeling and 
Simulation for Non-gastrointestinally Absorbed Drug Products in Humans (U01)

URL: 
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-012.html?source=govdelivery&utm_medium=email&utm_source=govdelivery

Cooperative agreement funding mechanism is open to educational, for-profit, 
non-profit, small business, and government organizations.

Application deadline: June 1, 2014

Background
Evaluation of equivalence for complex drug products, such as locally acting 
drug products and non-biological complex parenteral drug products, is 
challenging. In general, the challenges for those drug products are to relate 
critical quality contributes to in vitro performance, to relate in vitro 
performance to in vivo performance, including drug distribution at the site of 
action and plasma drug distribution, and ultimately to relate in vitro drug 
performance to clinical performance. Physiologically based absorption and PK 
models capture the best current understanding of the complex interplay between 
product attributes and human physiology. Therefore they can aid FDA in 
developing regulatory science and policies in these complex areas and aid the 
generic industry in designing high quality products that meet public 
expectations for equivalence.

Objectives
The objectives of this project are to develop, evaluate and improve 
physiologically based absorption and pharmacokinetic models for the following 
areas to support and facilitate generic drug guidance development, product 
development, and application review, in these areas.

Subtopic 1: Physiologically based pharmacokinetic modeling and simulation of 
dermal absorption
Subtopic 2: Physiologically based pharmacokinetic modeling and simulation of 
ocular absorption
Subtopic 3: Physiologically based pharmacokinetic modeling and simulation for 
non-biological complex parenteral drug products (including liposomes, 
nanosuspension, micelles, microspheres, implants, and hydrogels)
Subtopic 4: Physiologically based pharmacokinetic modeling and simulation of 
lung absorption via oral inhalation
Subtopic 5: Physiologically based pharmacokinetic modeling and simulation of 
absorption from nasally delivered products (including nasal solutions, 
suspensions as well as nasal insufflation as a potential route of abuse)

For each subtopic, the models should include but are not limited to formulation 
properties, drug substance properties, in vitro release mechanisms, physiology 
geometry, and microenvironment physiological parameters. The models should be 
based on the understanding of formulations, drug substance, physiology, 
mechanisms of drug delivery and mechanisms of drug transport. The final models 
should be able to predict drug concentration at the site of action, and drug 
plasma/blood concentration from various formulations.

Proposals should at least include a description of the model, and model 
validation plans. In the proposal, applicants should indicate the 
formulations/drug products that will be used as model drug products for model 
validation and evaluation. If solutions are used in model development and 
validation, they should not be the only formulations used for model validation.

Jan van der Valk, PhD | 3Rs-Centre Utrecht Life Sciences | NKCA | Dept. Animals 
in Science and Society | Fac. Veterinary Medicine | Utrecht University | 
Yalelaan 2 | NL-3584 CM Utrecht | The Netherlands | Email: 
j.vandervalk@xxxxx<mailto:j.vandervalk@xxxxx> | Ph. *31 30 253 2163 / 2186 | 
Fax.*31 30 253 7997 | URL: http://www.uu.nl/3RsCentreULS | Twitter: 
@3VCentrumULS |
[estiv] FDA Funding: Physiologically Based Absorption/PK Modeling for Non-GI Drugs

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