UCSF - Clinical and Translational Science Institute

DTRCS-Impact Service Request

The Integrated Model-based Pharmacometric Analysis of Clinical Trials (IMPACT), in association with the Regulatory Knowledge and Support and the Center for Drug Development Science, provides advanced study design and data analysis services for studies of pharmacokinetics, pharmacodynamics, clinical pharmacology, mechanism of pharmacological action, proof of concept, and any other translational, exploratory, learning or confirming studies of a preventive therapeutic, and diagnostic agent. IMPACT provides state-of-the-art services using advanced modeling and simulation technologies.

If you are a UCSF researcher or a CTSI affiliate, you can request a consultation by completing the form below. Fields marked with an asterisk are required. If you have not been contacted by a member of the RKS consulting team within three business days of submitting your request, email Julie.Nelson@ucsf.edu or call us at: 202-785-5450.

Important: all publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH Funding acknowledgement.

Information about you

First Name*

Last Name*

Email*

Phone

Mailbox

The information we're requesting below helps us understand your needs better and captures who we are serving. Thank you in advance for completing and submitting this form.

Degrees (check all that apply)

MD PhD MCR/MPH/MS DDS RN PharmD Other

Faculty Rank

Faculty Series

Non-faculty Title

If other, please specify

School (primary)*

Campus

If other, please specify

Department (primary affiliation)*

If other, please specify

Division or research unit, if applicable

Time spent on research

Time spent in clinic

Primary research type*

If other, please specify

Gender

Ethnicity

Race

Project Information

Title/Topic*

Grant Deadline/Study Start Date*

Sponsor/Source of Funding

Specify Name of Funding Source

Stage of Project (check one)

Planning study
Applying for funding
Implementing funded study
Responding to reviews
Other/Unsure:

Brief Description of the Project

Types of Pharmacometric Guidance Needed (Check all that apply)

Design of a Translational and Clinical Study

General design of a protocol
Selection of a therapeutic regimen
Selection of a dose or dose range
Optimal blood sampling time for PK and PD evaluation
Patient population including sample size
Data analysis plan specific to PK, PK-PD, and pharmacometric analysis

Advanced Pharmacometric Modeling and Simulations

Pharmacokinetics (Dose-Concentration)
Pharmacodynamics (Concentration-response)
Disease progression
Covariate analysis, i.e., population analysis of individual's demographic (e.g., age), clinical (e.g., stage, concomitant drug), or genetic (genotype) effects on PK or PD parameters
Physiologically based PK-PD
Mechanically based effect
Deconvolution

Conventional Phamacokinetic and Pharmacodynamic Analysis

Model-independent analysis using rich-sample data
Bioavailability
Bioequivalence
In vivo drug interaction
Drug disease interaction
Mass balance

Training and Education

Training and education of translational and clinical investigators in PK, PD, and pharmacometrics. This can be tailored based on individual's need and understanding of the disciplines.

Resources and Services for Use of Advanced Pharmacometric Software. IMPACT offers technical assistance for the following advanced software programs.

Unknown or other type of guidance (Please specify below)

Other/Unsure:

Anticipated Level of Assistance (Check all that apply)

Simple advice (probably single session)
Complex advice (probably multiple sessions)
Assist with writing
Other/Unsure:

DTRCS-Impact Service Request

Information about you

Project Information

Types of Pharmacometric Guidance Needed (Check all that apply)

Anticipated Level of Assistance (Check all that apply)

Other Comments