Introduction: As Korean pharmaceutical industry is reaching the golden era of drug discovery due to increased investments in R&D and…
Read morePoster: Methodology - Other topics
A semi-mechanistic dose-finding design in oncology using pharmacokinetic/pharmacodynamic modeling
Objectives: While a number of phase I dose-finding designs in oncology exist, the commonly used ones are either algorithmic or…
Read moreComputing Optimal Drug Dosing with OptiDose: Implementation in NONMEM
Objectives: Determining “optimal” drug dosing for a target population is still a complex, laborious and qualitative rather than quantitative task….
Read moreAluminium biokinetics: Elucidating the speciation kinetics of the aluminium-citrate system in vitro.
Objectives: As an element, aluminium (Al) does not undergo metabolism in biological systems, but rather distributes into a plethora of…
Read moreModel-based approaches to prospectively power pediatric pharmacokinetic trials with limited sample size
Introduction: In most drug development programs, sponsors are recommended to submit a pediatric plan with the purpose of identifying the…
Read moreA new computational approach to match control subjects to renal impaired patients in pharmacokinetic studies
Introduction: Most of drugs that are likely to be administered to patients with renal impairment should be investigated in this…
Read moreExtension of the Janmahasatian fat-free mass model to account for ethnicity-related bias
Objectives: The FFM model developed by Janmahasatian et al. (FFMJan) [1] has been extensively used in clinical pharmacology studies. The…
Read moreUnveiling the Potential of Cmax Æ’2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies
Objectives: When companies are uncertain of the potential of a new formulation to be bioequivalent to a Reference product, it…
Read moreEasy and reliable maximum a posteriori Bayesian estimation of pharmacokinetic parameters with the open-source R package mapbayr
Objectives: Pharmacokinetic (PK) parameter estimation is a critical and complex step in the Model-Informed Precision Dosing (MIPD) approach. Maximum a…
Read moreA review of fixed-dose combination approvals in the EU based on European public assessment reports (EPARs)
Introduction: Fixed dose-combination (FDC) products, a subset of combination therapies, contain a fixed ratio of two or more active ingredients…
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