Katja Heinig
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View article: P-01.05 IOMX-0675, a LILRB1/LILRB2 cross-specific antibody that reprograms the tumor microenvironment to trigger potent anti-tumor activity
P-01.05 IOMX-0675, a LILRB1/LILRB2 cross-specific antibody that reprograms the tumor microenvironment to trigger potent anti-tumor activity Open
View article: Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children
Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children Open
View article: Relative bioavailability and food effect study of an oral suspension of alectinib in healthy volunteers using venipuncture and capillary microsampling
Relative bioavailability and food effect study of an oral suspension of alectinib in healthy volunteers using venipuncture and capillary microsampling Open
Alectinib, approved as 150 mg capsules for the treatment of adults with advanced ALK ‐positive non‐small cell lung cancer, is being assessed in children with ALK ‐positive solid and central nervous system tumors. An ad hoc pediatric‐friend…
View article: Effect of mild or moderate hepatic impairment on the pharmacokinetics of risdiplam
Effect of mild or moderate hepatic impairment on the pharmacokinetics of risdiplam Open
Aim This phase I, multicentre, open‐label, nonrandomised, parallel‐group, two‐part study aimed to evaluate the effect of mild to moderate hepatic impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of ris…
View article: Addressing Today’s Absorption, Distribution, Metabolism, and Excretion (ADME) Challenges in the Translation of In Vitro ADME Characteristics to Humans: A Case Study of the SMN2 mRNA Splicing Modifier Risdiplam
Addressing Today’s Absorption, Distribution, Metabolism, and Excretion (ADME) Challenges in the Translation of In Vitro ADME Characteristics to Humans: A Case Study of the SMN2 mRNA Splicing Modifier Risdiplam Open
Small molecules that present complex absorption, distribution, metabolism, and elimination (ADME) properties can be challenging to investigate as potential therapeutics. Acquiring data through standard methods can yield results that are in…
View article: Model‐Based Drug–Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy
Model‐Based Drug–Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy Open
Risdiplam (Evrysdi) improves motor neuron function in patients with spinal muscular atrophy (SMA) and has been approved for the treatment of patients ≥2 months old. Risdiplam exhibits time‐dependent inhibition of cytochrome P450 (CYP) 3A i…
View article: Risdiplam distributes and increases <scp>SMN</scp> protein in both the central nervous system and peripheral organs
Risdiplam distributes and increases <span>SMN</span> protein in both the central nervous system and peripheral organs Open
Spinal muscular atrophy ( SMA ) is a rare, inherited neuromuscular disease caused by deletion and/or mutation of the Survival of Motor Neuron 1 ( SMN 1) gene. A second gene, SMN 2 , produces low levels of functional SMN protein that are in…
View article: A phase 1 healthy male volunteer single escalating dose study of the pharmacokinetics and pharmacodynamics of risdiplam (RG7916, RO7034067), a <i>SMN2</i> splicing modifier
A phase 1 healthy male volunteer single escalating dose study of the pharmacokinetics and pharmacodynamics of risdiplam (RG7916, RO7034067), a <i>SMN2</i> splicing modifier Open
Aims Risdiplam (RG7916, RO7034067) is an orally administered, centrally and peripherally distributed, survival of motor neuron 2 ( SMN2 ) mRNA splicing modifier for the treatment of spinal muscular atrophy (SMA). The objectives of this ent…
View article: 2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 1 – Small Molecules by LCMS)
2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 1 – Small Molecules by LCMS) Open
The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research orga…
View article: An <i>Ex Vivo</i> Potency Assay to Assess Active Drug Levels of A Glp-1 Agonistic Peptide During Preclinical Safety Studies
An <i>Ex Vivo</i> Potency Assay to Assess Active Drug Levels of A Glp-1 Agonistic Peptide During Preclinical Safety Studies Open
We were able to show that despite a high total test compound level, activity was reduced tremendously in antidrug-antibody-positive monkeys. Therefore, the applied ex vivo potency assay supplements drug quantification methods to determine …