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In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop.

The use of electrospraying as a means of drug loading into mesoporous silica particles for enhanced dissolution, presented at the 13th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical (PBP) Technology 2022

Learn about drug substance and formulation considerations for improving downstream clinical outcomes. Access on demand.

A Decade of Human ADME at Quotient Sciences: Reviewing Key Study Design Variables and Outcomes.

Practical and operational considerations related to paediatric oral drug formulation: An industry survey.

Understanding the Absorption, Metabolism and Excretion of Masitinib in Healthy Male Subjects.

Safety, tolerability, and pharmacokinetics of the oligomer modulator anle138b: a first-in-human randomised, double-blind, placebo-controlled Phase 1 trial

A Phase I Study of the Cancer-specific Vaccine FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response

Benznidazole pharmacokinetics in adults and children: Application of PBPK modelling.

Development of a novel oral suspension formulation of a candidate API for administration to paediatric patients.

Qualification of Gastroplus® PBPK modelling software to support decision-making in clinical development.

Controlled synthesis of SPION@SiO2 nanoparticles using design of experiments.