Results 131 to 140 of about 95,952 (294)

Mechanism‐informed machine learning for individualized tacrolimus dose adjustment in the early post‐kidney transplant period

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tacrolimus dosing in the early post‐kidney transplant period is challenging due to a narrow therapeutic index and substantial interindividual pharmacokinetic (PK) variability. This study aimed to develop and validate mechanism‐informed machine learning (ML) models to support individualized tacrolimus dosing during this critical period ...
Hui Yu, Zihan Qin, Logan S. Smith, Jeong M. Park, Hao‐Jie Zhu   +4 more
wiley   +1 more source

Early clinical pharmacology evaluation of the novel anti‐inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims This work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti‐inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: ‘first‐in‐human’ (FIH) and ‘drug–drug‐interaction’ (DDI).
Dave Singh, Kate Hanrott, Olof Breuer, Johan Bylund, Björn Schultze, Virginia Norris   +5 more
wiley   +1 more source

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

British Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert, Carl M. J. Kirkpatrick, Rory Marriott, Siladitya Ray Chaudhuri, David Polidori, Bart Remmerie, Michelle P. McIntosh   +6 more
wiley   +1 more source

New Peceol™/Span™ 60 Niosomes Coated with Chitosan for Candesartan Cilexetil: Perspective Increase in Absolute Bioavailability in Rats. [PDF]

Int J Nanomedicine, 2021
AbuElfadl A, Boughdady M, Meshali M.
europepmc   +1 more source

Quantitative prediction of intravenous drug interactions caused by cytochromes P450 inhibitors and inducers

British Journal of Clinical Pharmacology, EarlyView.
Background Aims Pharmacokinetic interaction studies typically focus on oral administration, but intravenous (IV) administration bypasses intestinal degradation and hepatic first‐pass metabolism, leading to distinct drug–drug interaction (DDI) magnitude. This study aimed to develop a predictive model for DDIs involving IV‐administered drugs.
Vianney Tuloup, Michel Tod, Laurent Bourguignon   +2 more
wiley   +1 more source

Correction to: The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [¹⁴C]‑BI 425809 in Healthy Males. [PDF]

Clin Drug Investig, 2022
Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS.   +8 more
europepmc   +1 more source

Endogenous melatonin partial metabolic clearance as a potential endogenous marker of CYP1A2 activity

British Journal of Clinical Pharmacology, EarlyView.
Aims Cytochrome P450 1A2 (CYP1A2) exhibits substantial interindividual variability, necessitating appropriate phenotyping strategies for personalized pharmacotherapy. This study evaluated endogenous melatonin partial metabolic clearance (CLm(MEL)), calculated from urinary 6‐hydroxymelatonin (6‐O‐MEL) excretion and plasma melatonin (MEL) exposure, as a ...
Akitomo Yokokawa, Hayato Shimazaki, Shunji Igarashi, Yoshiki Tagawa, Naoki Hisada, Hiromi Shibasaki   +5 more
wiley   +1 more source

The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [¹⁴C]-BI 425809 in Healthy Males. [PDF]

Clin Drug Investig, 2022
Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS.   +8 more
europepmc   +1 more source

Dissolution Rates of Mangosteen (Garcinia mangostana L.) Pericarps Extract Granules in Synthetic Human Gastrointestinal Fluid [PDF]

, 2014
Mangosteen (Garcinia mangostana L.) pericarps contain prenylated xanthone derivates, which exhibit some pharmacological activities, such as antiinflammatory, antihistamine, antibacterial, antivirus, antifungal, antioxidant, and antiulcerogenic.
Kumoro, A.C., Solikhati, A.
core  

Addressing Small Data Challenges in Biopharmaceutical Development and Manufacturing: A Mini Review of Multi‐Fidelity Techniques

Biotechnology and Bioengineering, EarlyView.
ABSTRACT The growing demand for biopharmaceutical products reflects their effectiveness in medical treatments. However, developing new biopharmaceuticals remains a major bottleneck, often taking up to a decade before market approval. Machine learning (ML) models have the potential to accelerate this process, but their success depends on access to large
Mohammad Golzarijalal, Uwe Aickelin, Ellen Otte   +2 more
wiley   +1 more source