Human metabolism of lapatinib, a dual kinase inhibitor: implications for hepatotoxicity

…, K Koch, DJ Borts, GD Bowers, C MacLauchlin - Drug Metabolism and …, 2012 - ASPET
Lapatinib (Tykerb, Tyverb) is an important orally active dual tyrosine kinase inhibitor
efficacious in combination therapy for patients with progressive human epidermal receptor 2-…

The nonclinical disposition and pharmacokinetic/pharmacodynamic properties of N-Acetylgalactosamine–conjugated small interfering RNA are highly predictable and …

…, J Kurz, J Li, J Liu, X Liu, S Liou, C Maclauchlin… - Drug Metabolism and …, 2022 - ASPET
Conjugation of oligonucleotide therapeutics, including small interfering RNAs (siRNAs) or
antisense oligonucleotides, to N-acetylgalactosamine (GalNAc) ligands has become the …

[HTML][HTML] Analyzing the mechanisms behind macrolide antibiotic-induced liver injury using quantitative systems toxicology modeling

JL Woodhead, K Yang, D Oldach, C MacLauchlin… - Pharmaceutical …, 2019 - Springer
Purpose Macrolide antibiotics are commonly prescribed treatments for drug-resistant bacterial
infections; however, many macrolides have been shown to cause liver enzyme elevations …

A randomized study evaluating oral fusidic acid (CEM-102) in combination with oral rifampin compared with standard-of-care antibiotics for treatment of prosthetic joint …

…, K Keedy, C MacLauchlin… - Clinical infectious …, 2016 - academic.oup.com
Background. Fusidic acid (FA) has been used for decades for bone infection, including
prosthetic joint infection (PJI), often in combination with rifampin (RIF). An FA/RIF …

[HTML][HTML] Leveraging microphysiological systems to address challenges encountered during development of oligonucleotide therapeutics

…, DA Dalmas, SH Stahl, C Maclauchlin… - ALTEX-Alternatives to …, 2022 - altex.org
Oligonucleotide therapeutics (ONTs) encompass classes of medicines that selectively target
and potentially ameliorate previously untreatable and often rare diseases. Several unique …

The nonclinical disposition and PK/PD properties of GalNAc-conjugated siRNA are highly predictable and build confidence in translation to man

…, J Kurz, J Li, S Liou, J Liu, X Liu, C Maclauchlin… - Drug Metabolism and …, 2021 - ASPET
Conjugation of oligonucleotide therapeutics, including small interfering ribonucleic acids (siRNAs)
or antisense oligonucleotides (ASOs) to N-acetylgalactosamine (GalNAc) ligands has …

[HTML][HTML] Clinical and preclinical single-dose pharmacokinetics of VIR-2218, an RNAi therapeutic targeting HBV infection

SV Gupta, MC Fanget, C MacLauchlin, VA Clausen… - Drugs in R&D, 2021 - Springer
Background and Objective VIR-2218 is an investigational N-acetylgalactosamine–conjugated
RNA interference therapeutic in development for chronic hepatitis B virus (HBV) infection. …

Contribution of metabolites to P450 inhibition–based drug–drug interactions: scholarship from the drug metabolism leadership group of the innovation and quality …

…, J Mao, WG Lai, AJ Lee, HK Lim, C MacLauchlin… - Drug Metabolism and …, 2015 - ASPET
Recent European Medicines Agency (final) and US Food and Drug Administration (draft) drug
interaction guidances proposed that human circulating metabolites should be investigated …

Utilizing drug-drug interaction prediction tools during drug development: enhanced decision making based on clinical risk

CE Shardlow, GT Generaux, CC MacLauchlin… - Drug metabolism and …, 2011 - ASPET
Several reports in the literature present the utility and value of in vitro drug-metabolizing
enzyme inhibition data to predict in vivo drug-drug interactions in humans. A retrospective …

Metabolism, excretion, and mass balance of solithromycin in humans

C MacLauchlin, SE Schneider, K Keedy… - Antimicrobial Agents …, 2018 - Am Soc Microbiol
Solithromycin, a novel macrolide and the first fluoroketolide, is being developed as a therapy
for community-acquired bacterial pneumonia, with a distinct mechanism that provides …