Events Search and Views Navigation
November 2017
Optimal design and analysis of clinical trials
November 9, 2017 at 14:00 – 16:00 Benzon Auditorium, University of Copenhagen Universitetsparken 2, 2100 København Ø Careful planning of the clinical trial design is pertinent in obtaining the best estimation of the dose-response or exposure-response relationships. Thus, issues in trial conduct such as design, dose-selection, sample size allocations and analyses should be thoughtfully addressed during trial design in order to get the best precision of parameter estimates. The current meeting will give an overview on optimal design opportunities and…
Find out more »September 2018
PopSim Meeting: Adding confidence to your pharmacometric models
Please be invited for a new PopSim meeting on September 12th 2018. This time we have an exciting agenda on uncertainties in nonlinear mixed effects models. Pharmacometric models are gaining increasing impact on decision-making in drug development and clinical therapy. As a consequence the uncertainties involved in model predictions become increasingly important. At this meeting we will discuss the various possibilities and assumptions when calculating and presenting confidence intervals in different settings relevant to clinical drug development. In particular we…
Find out more »March 2019
PopSim Meeting: Updated EMA guideline – Background and implications for design of First-In-Man trials
This event has passed. For the PopSim meeting on Dose Finding in Drug Development, September 7, 2020 please go to http://farmaceutisk-selskab.dk/arrangementer/popsim-meeting-2020-dose-finding/ An update of the EMA guideline on strategies to identify and mitigate risks for first-in-man and early clinical trials came into effect on February 1st, 2018. This update was directly motivated by a serious accident occurring during a first-in-man trial conducted for the pharmaceutical company Bial. At this PopSim meeting we will have a close look at the trial that has…
Find out more »September 2020
Dose Finding in Drug Development
Dose Finding in Drug Development Adequate dose finding is essential in clinical drug development for achieving regulatory approval. Uncertainty pertaining to the adequacy of the proposed marketing dose(s) is a frequent reason for denial of new molecular entity (NME) applications and a significant number of marketing authorization applications has major objections raised due to unjustified doses. At this PopSim meeting we will have a close look at what data is usually included in a regulatory submission to justify…
Find out more »