AbbVie (United States)

Local Pharmacokinetics and Tolerability of Topically‐Applied Bimatoprost to the Scalp of Male Patients With Androgenetic Alopecia

ABSTRACT Androgenetic alopecia (AGA) is one of the most common causes of hair loss in the male population, characterized by progressive baldness. This study was designed to evaluate the tolerability and local skin pharmacokinetics of bimatoprost in two different formulations in m...

Practical Scale-Up of Trickle Bed Continuous Hydrogenation for Pharmaceuticals

Abstract There is a growing trend in the pharmaceutical industry toward the adoption of continuous processing for the synthesis of active pharmaceutical ingredients (APIs) and intermediates. This enables access to novel synthetic routes by operating at high temperatures and high...

A new standard for lyophilizer characterization, comparability and efficient technology transfers

This paper details the implementation of the ΔT and ΔP methodologies—recently introduced in the literature—for monitoring of mass flow during sublimation, demonstrating their application across multiple pharmaceutical companies. As a relatively new approach, this work is assessin...

Self-normalization tests for change points in functional time series

Change point detection for functional time series has attracted considerable attention. Existing methods either rely on functional principal component analysis (FPCA), whose finite dimensional projection may perform poorly with complex data, or use bootstrap approaches whose test...

BAP: Bayesian Biomarker-Assisted Platform Design for Dose Ranging in Multi-Agent Multi-Dose Trials

Assessing the long-term benefits of new treatments can be expensive and time-consuming, particularly in disease areas with unmet medical needs. While platform trials enable the evaluation of multiple interventions simultaneously, they currently cannot assess studies involving mul...

Exposure–Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma

Epcoritamab is approved for treating various relapsed/refractory (R/R) lymphomas. In a phase I/II study in R/R follicular lymphoma (FL) patients, epcoritamab demonstrated high response rates (EPCORE NHL-1: objective response rate [ORR]: 82.0%, complete response [CR] rate: 62.5% [...