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BIOF 084 | Pharmacometric Dose-Response Analyses in Clinical Trials Using R

November 12, 2019 to November 15, 2019

Registration occurs on a first-come, first-served basis. The deadline for registration is one week before the first day of the course.  If you are unable to register before the deadline, please email: or call 301-496-7977 for space availability. 

NIH Fellows or those being sponsored by their lab can enroll tentatively, using the Contract: SF-182 option on the workshop’s registration site while waiting for authorization of payment. Enrollment is not guaranteed until payment is received.

Register Now

Contract: SF-182

In order for a drug to get approved by the FDA for market in the USA, the sponsor must ultimately demonstrate the drug has: 1) a predictable exposure profile with dose, 2) a good safety profile, and 3) is effective at safe doses.  Therefore, the pharmacology of a drug is essentially being reviewed by the FDA. The ability of scientists to analyze drug exposure/response relationships is crucial to understanding what exposure amount will elicit the safest, most effective response, and ultimately what dose amount and frequency will produce the optimal exposure amount. Additionally, the ability to identify sub-populations that may produce differing exposure or response levels is key to providing as many subjects as possible a safe and effective dose.  This quantitative exposure/response analyses, often referred to pharmacometrics, is key to making go/no go decisions both during clinical trials by investigators, and the FDA during the subsequent review period.

Participants will learn basic pharmacology theory with introductory statistics using a popular open source software program (R Studio) that is capable of conducting pharmacokinetic (PK) exposure and pharmacodynamic (PD) response analyses from example clinical trial data. Ultimately, the framework of analyzing exposure/response relationships will be demonstrated in order to make go/no go decisions.

1.  Introduction to a broad range of pharmacology topics
2.  Introduction to a basic level of statistical analyses for clinical trial data
3.  Introduction to the basics of computer coding necessary for R Studio
4.  Framework of analyses laid for post-course continuing education

5.  Training provided by active NIH researchers

Who should attend
1.  Clinicians and researchers interested in learning how to utilize freely available software to explore, visualize and understand drug exposure/response relationships, where responses include any clinical endpoint collected on a trial.
2.  Clinicians and researchers interested in understanding and predicting the effect of different doses on drug exposure, and effect of exposure on a variety of clinically-relevant response endpoints (biomarkers).
3.  Medical, pharmacy, dental, nursing, and lab-based graduate school students interesting in obtaining a deeper understanding of pharmacokinetics, exposure/response analyses, and a broad understanding of clinical drug development and the impact of pharmacometrics on decisions.

Hands-on Skills/Tools Taught
1. Noncompartmental analysis of pharmacokinetic data using R Studio
2. Statistical hypothesis testing of clinical trial data using R Studio
3. Exposure/response analyses using R Studio

Workshops generally run from 9:00am - 5:00pm.​

Outline Agenda

Day 1
9:00a – 9:15a: General Introduction
9:15a – 10:15a: Introduction to R
10:15a – 10:30a: Morning Break
10:30a – 12:00p: Introduction to Pharmacokinetics (PK)
12:00p – 1:00p: Lunch Break
1:00p – 3:00p: Using R for PK
3:00p – 3:15p: Afternoon Break
3:15p – 4:00p: Clinical Trial Design
4:00p – 4:30p: Summary and Questions

Day 2
9:00a – 10:15a: Day 1 Recap/Overflow Understanding Clinical Trial Data w/ Statistics
10:15a – 10:30a: Morning Break
10:30a – 12:00p: Exposure/Response modeling I
•           Linear models
•           Continuous vs Continuous (Linear Regression)
12:00p – 1:00p: Lunch Break
1:00p – 2:30p: Exposure/Response modeling II-A
•           Odds Ratio
•           Relative Risk
•           Chi-Squared Tests
2:30p – 2:45p: Afternoon Break
2:45p – 4:15p: Exposure/Response modeling II-B
•           Logistic regression
•           Bernoulli Distributions
•           GLM
4:15p – 4:30p: Summary and Questions

Day 3
9:00a – 9:30a: Day 2 Recap/Overflow
9:30a – 10:30a: Exposure/Response modeling III-A
•           Ordinal data
•           Proportional Odds Model
10:30a – 10:45a: Morning Break
10:45a – 12:00p: Exposure/Response modeling III-B
•           Poisson Regression
•           Count Data
12:00p – 1:00p: Lunch Break
1:00p – 2:30p: Exposure/Response modeling III-C
•           Longitudinal data
•           GEE and GLMM
2:30p – 2:45p: Afternoon Break
2:45p – 4:30p: Workshop Dose Decision Making Exercise I
•           Analyzing Clinical Data
•           Making Go/NoGo Decisions
4:30p: Summary and Questions

Day 4
9:00a – 10:15a: Exposure/Response modeling IV
•           Survival data
•           Cox Proportional Hazards Model
10:15a – 10:30a: Morning Break
10:30a – 12:00p: Exposure/Response Modeling IV (cont)
12:00p – 1:00p: Lunch Break
1:00p – 2:00p: Workshop Dose Decision Making Exercise II
•           Analyzing Clinical Data
•           Making Go/NoGo Decisions
2:00p – 2:15p: Final comments, Certificates, and Feedback

Comprehensive Binder
Contains all notes, protocols, and reference material needed. No additional books are required. 

Although no grades are given for courses, each participant will receive Continuing Education Units (CEUs) based on the number of contact hours.   One CEU is equal to ten contact hours.  Upon completion of the course each participant will receive a certificate, showing completion of the workshop and 2.8 CEUs.

Refund Policy
100% tuition refund for registrations cancelled 14 or more days prior to the start of the workshop.
50% tuition refund for registrations cancelled between 4 to 13 days prior to the start of the workshop.
No refund will be issued for registrations cancelled 3 days or less prior to the start of the workshop.

All cancellations must be received in writing via email to Ms. Carline Coote at
Cancellations received after hours are time marked for the following day. 
All refund payments will be processed by the start of the initial workshop.

Suggested Lodging Accommodations:
A special rate is available to all workshop attendees. This includes complimentary buffet breakfast, guest room Wi-Fi, and discounted $15 parking per night. The hotel provides complimentary shuttle service to/from the NIH campus. The hotel is also within walking distance of the training facility. Reservations can be made online, see below. 

The Bethesdan Hotel by Hilton



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