Saturday, September 13, 2025 9/13/2025

Mechanistic Pharmacokinetics and Pharmacodynamics

Award Number: R35GM131800
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2025

Group Awards By:

View Award Description

Mechanistic Pharmacokinetics and Pharmacodynamics - Abstract This program seeks firstly to provide increased understanding of pharmacokinetics (PK) and mechanisms of corticosteroid (CS) effects on genomic, proteomic, and physiologic processes associated with endocrine, metabolic, and pharmacologic responses from local to systems levels for CS dosed acutely and chronically. Secondly, the mechanisms of action and interaction of multiple agents offering potential joint therapy of pancreatic cancer will be examined. Thirdly, these specific study results will be integrated with relevant information from the literature to develop improved mechanism-based PK and pharmacodynamic (PK/PD) models and methods spanning and offering insights at basic, complex, and systems pharmacologic levels. Overall, our goals are development of mechanistic pharmacologic and disease models that reveal and interrelate the `rules of biology and pharmacology' at various levels of biological organization and allow improved quantitation and prediction of in vivo hormone and drug effects. The cancer drug studies utilize cell cultures, proteomics, and network analyses with an emphasis on seeking natural synergy of multiple agents and evolving new methods for quantitating drug interactions. Our experimental paradigm for CS studies has been large carefully controlled studies in groups of animals subjected to defined conditions or drug treatments (“giant rat” studies). Blood and major organs will be harvested from male and female rats over timeframes reflecting either endogenous biorhythms or the onset and recovery of changes produced by single drug doses or prolonged disturbances of homeostasis produced by disease and chronic drug exposures. We examine involvement of short rhythms (circadian) within longer biorhythms (estrous cycle, seasons), assess sex differences in disease processes and steroid actions particularly in rheumatoid arthritis, and evolve and apply physiologically relevant basic PK/PD to extensive systems pharmacologic approaches. Our methods and interdisciplinary collaborations include extensive laboratory-based experiments, state-of-the-art bioanalysis methods, generation of “big data” sets of –omics response data, various computational platforms, expert knowledge about diverse biological processes, and offer the imagination and insights to recognize new principles that emerge and underlie the complexities of how drugs, hormones, and natural compounds work and interact in the body. These efforts encompass and enrich both basic PK/PD and systems modeling, but with emphasis on enhanced physiological models that attend complex mechanisms of drug action. These holistic studies and mathematical modeling innovations will provide improved multi-scale understanding of critical biological, hormone, and pharmacologic functions and will continue to offer wide applications in quantitative pharmacology.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$18,323 )
2025	2023	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	001	5	8/26/2025	NON-COMPETING CONTINUATION	-$18,323
2025	2023	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	000	5	11/7/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = -$18,323

Issue Date FY: 2023 ( Subtotal = $597,804 )
2023	2023	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	000	5	4/7/2023	NON-COMPETING CONTINUATION	$597,804
														Subtotal = $597,804

Issue Date FY: 2022 ( Subtotal = $596,511 )
2022	2022	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	000	4	4/26/2022	NON-COMPETING CONTINUATION	$596,511
														Subtotal = $596,511

Issue Date FY: 2021 ( Subtotal = $598,595 )
2021	2021	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	000	3	4/15/2021	NON-COMPETING CONTINUATION	$598,595
														Subtotal = $598,595

Issue Date FY: 2020 ( Subtotal = $598,456 )
2020	2020	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	000	2	4/17/2020	NON-COMPETING CONTINUATION	$598,456
														Subtotal = $598,456

Issue Date FY: 2019 ( Subtotal = $500,311 )
2019	2019	RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK, THE	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Biomedical Research and Research Training	000	1	4/26/2019	NEW	$500,311
														Subtotal = $500,311

Grand Total All Awards = $2,873,354

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Mechanistic Pharmacokinetics and Pharmacodynamics

Award Number: R35GM131800

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer