NONMEM Users Network Archive

Hosted by Cognigen

New ORISE fellow positions available at the Division of Quantitative Methods and Modeling of the Food and Drug Administration

From: Gonzalez Sales, Mario <Mario.Gonzalezsales>
Date: Wed, 18 Jan 2017 03:09:11 +0000

Dear NONMEM users,

The Division of Quantitative Methods and Modeling (DQMM) in the Office of R=
esearch and Standards (ORS) within the Office of Generic Drugs (OGD) of the=
 Food and Drug Administration is growing fast and we have new Oak Ridge Ins=
titute for Science (ORISE) fellow positions available.

DQMM provides expertise in advanced quantitative methods for the generic dr=
ug program and conducts GDUFA (Generic Drug User Fee Amendments 2012) regul=
atory science and research activities based on quantitative approaches, whi=
ch include guidance development, abbreviated new drug application (ANDA) re=
views, citizen petitions, controlled correspondence, pre-ANDA meetings, and=
 methodology development for bioequivalence evaluation, active ingredient s=
ameness demonstration and post marketing safety surveillance. This Divisio=
n coordinates modeling, simulation, data analysis and data mining and estab=
lishes the scientific computing infrastructure for OGD. DQMM is also develo=
ping innovative quantitative approaches to improve regulatory decision maki=
ng for generic drugs by fully utilizing the large amount of data available =
to FDA. The ORISE position(s) at DQMM provides an outstanding opportunity =
to learn and apply quantitative analysis, modeling, and simulation to suppo=
rt the aforementioned activities.

Research at DQMM includes, but not limited to, the following areas:

* Modeling and simulation of modified release solid oral products (=
including absorption models, in vitro - in vivo correlations and pharmacoki=
netic/pharmacodynamic [PK/PD] modeling) to ensure the consistency and quali=
ty of bioequivalence recommendations from OGD.

* Model-based delivery system assessment.

* Innovative approaches to establish active ingredient sameness/pha=
rmaceutical equivalence for complex drug substances.

* In vitro bioequivalence analyses.

* Application of physiologically based pharmacokinetic (PBPK) model=
s for non-oral drug products to help develop new bioequivalence methods for=
 locally acting drug products administered via non-oral routes of administr=

* PK/PD modeling of narrow therapeutic index drugs and complex drug=
 products and clinical trial simulation to aid risk-based bioequivalence ev=

* Conventional and model-based meta-analysis on drugs within same c=
lass or different classes.

* Conducting safety surveillance by developing/applying novel analy=
sis approaches to detect and assess safety signals of generic products.

* Developing systems pharmacology-based methodologies to understand=
 and predict drug actions underlying both therapeutic effect and adverse re=

* Establishing data infrastructure to increase ANDA review efficien=
cy and quality by providing integrated and readily searchable information b=
ased on available NDAs and ANDA datasets regarding drug efficacy and safety=


* Ph.D., M.D., Pharm.D., or other qualified scientists holding adva=
nced degree(s) in pharmacometrics, Clinical Pharmacology, Pharmaceutical Sc=
iences, Chemistry, Statistics, Life Science, or Engineering.

* Hands-on experience with modeling and simulation software (e.g. N=
ONMEM, SAS, Splus/R, Phoenix, Monolix, MATLAB, C++, GastroPlus, Simcyp, PKS=
im, etc.).

* Good knowledge of formulation design, biopharmaceutics, data anal=
ysis and/or modeling and simulation principles.

* Good scientific writing, communication, critical thinking, and in=
terpersonal skills.

For ORISE positions, the initial appointment is for one year.


Silver Spring, MD


Please send CV to Jae Wook Yoo

Best regards,

Mario Gonzalez Sales, Ph.D
Division of Quantitative Methods and Modelling
10903 New Hampshire Ave., Bldg 75, Room 4695
Silver Spring, MD 20993
Phone: (301)-796-7365
Email: mario.gonzalezsales

Received on Tue Jan 17 2017 - 22:09:11 EST

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to:

Once subscribed, you may contribute to the discussion by emailing: