Clinical Pharmacology and Therapeutics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Reply to "Interpretation of Pharmacovigilance Disproportionality Analyses"
Clin Pharmacol Ther. 2023 Jun 1. doi: 10.1002/cpt.2950. Online ahead of print.NO ABSTRACTPMID:37259792 | DOI:10.1002/cpt.2950 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - June 1, 2023 Category: Drugs & Pharmacology Authors: Viktoryia Prontskus Audrey Fresse M élissa Yelehe Mathilde Beurrier Pierre Gillet Source Type: research

Interpretation of Pharmacovigilance Disproportionality Analyses
Clin Pharmacol Ther. 2023 May 30. doi: 10.1002/cpt.2951. Online ahead of print.NO ABSTRACTPMID:37248829 | DOI:10.1002/cpt.2951 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 30, 2023 Category: Drugs & Pharmacology Authors: Charles Khouri Michele Fusaroli Francesco Salvo Emanuel Raschi Source Type: research

Assessment of the acute effects of 2C-B vs psilocybin on subjective experience, mood and cognition
Clin Pharmacol Ther. 2023 May 30. doi: 10.1002/cpt.2958. Online ahead of print.ABSTRACT2,5-dimethoxy-4-bromophenethylamine (2C-B) is a hallucinogenic phenethylamine derived from mescaline. Observational and preclinical data have suggested it to be capable of producing both subjective and emotional effects on par with other classical psychedelics and entactogens. Whereas it is the most prevalently used novel serotonergic hallucinogen to date, it's acute effects and distinctions from classical progenitors have yet to be characterised in a controlled study. We assessed for the first time the immediate acute subjective, cognit...
Source: Clinical Pharmacology and Therapeutics - May 30, 2023 Category: Drugs & Pharmacology Authors: Pablo Mallaroni Natasha L Mason Johannes T Reckweg Riccardo Paci Sabrina Ritscher Stefan W Toennes Eef L Theunissen Kim P C Kuypers Johannes G Ramaekers Source Type: research

Reply to "Questioning Bayesian Inference-Based Models for Estimating Culprit Drugs for Adverse Drug Reactions"
Clin Pharmacol Ther. 2023 May 29. doi: 10.1002/cpt.2935. Online ahead of print.NO ABSTRACTPMID:37246749 | DOI:10.1002/cpt.2935 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 29, 2023 Category: Drugs & Pharmacology Authors: Kazuki Hamada Takeshi Abe Kyoji Kouda Masahiko Nakatsui Takashi Kitahara Kazuto Matsunaga Yoshiyuki Asai Source Type: research

Machine Learning Application Identifies Germline Markers of Hypertension in Ovarian Cancer Patients Treated with Carboplatin, Taxane and Bevacizumab
In this study, ML techniques were used to investigate the relationship between genetic variations affecting more than 60 candidate genes and carboplatin-, taxane-, and bevacizumab-induced toxicities in 171 patients with ovarian cancer enrolled in the MITO-16A/MaNGO-OV2A trial. Single nucleotide polymorphism (SNP) profiles were examined using ML to find and prioritise those associated with drug-induced toxicities, specifically hypertension, hematological toxicity, non-hematological toxicity, and proteinuria. The Boruta algorithm was used in cross-validation to determine the significance of SNPs in predicting toxicities. Imp...
Source: Clinical Pharmacology and Therapeutics - May 27, 2023 Category: Drugs & Pharmacology Authors: Maurizio Polano Luca Bedon Michele Dal Bo Roberto Sorio Michele Bartoletti Elena De Mattia Erika Cecchin Carmela Pisano Domenica Lorusso Andrea Alberto Lissoni Andrea De Censi Sabrina Chiara Cecere Paolo Scollo Sergio Marchini Laura Arenare Ugo De Giorgi Source Type: research

Flucloxacillin is a weak inducer of CYP3A4 in healthy adults and 3D spheroid of primary human hepatocytes
In conclusion, flucloxacillin is a weak inducer of CYP3A4, which may lead to clinically relevant drug-drug interactions for some narrow therapeutic range drugs that are substrates of CYP3A4.PMID:37235733 | DOI:10.1002/cpt.2959 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 26, 2023 Category: Drugs & Pharmacology Authors: Ditte B Iversen Ann-Cathrine Dalg ård Dunvald Daniel M Jespersen Flemming Nielsen Kim Br øsen Per Damkier Helen S Hammer Oliver P ötz Erkka J ärvinen Tore B Stage Source Type: research

Questioning Bayesian Inference-Based Models for Estimating Culprit Drugs for Adverse Drug Reactions
Clin Pharmacol Ther. 2023 May 23. doi: 10.1002/cpt.2933. Online ahead of print.NO ABSTRACTPMID:37221698 | DOI:10.1002/cpt.2933 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 24, 2023 Category: Drugs & Pharmacology Authors: Yoshihiro Noguchi Miao Yan Tomoaki Yoshimura Source Type: research

A quantitative systems pharmacology model describing the cellular kinetic-pharmacodynamic relationship for a live biotherapeutic product to support microbiome drug development
Clin Pharmacol Ther. 2023 May 23. doi: 10.1002/cpt.2952. Online ahead of print.ABSTRACTLive biotherapeutic products (LBPs) are human microbiome therapies showing promise in the clinic for a range of diseases and conditions. Describing the kinetics and behavior of LBPs poses a unique modeling challenge since, unlike traditional therapies, LBPs can expand, contract, and colonize the host digestive tract. Here, we present a novel cellular kinetic-pharmacodynamic quantitative systems pharmacology (QSP) model of an LBP. The model describes bacterial growth and competition, vancomycin effects, binding and unbinding to the epithe...
Source: Clinical Pharmacology and Therapeutics - May 23, 2023 Category: Drugs & Pharmacology Authors: Marissa Renardy Alexander J Prokopienko Joseph R Maxwell Deborah A Flusberg Sahak Makaryan Jangir Selimkhanov Majid Vakilynejad Kalyanasundaram Subramanian Lucia Wille Source Type: research

Physician Perspectives on FDA's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease
Clin Pharmacol Ther. 2023 May 23. doi: 10.1002/cpt.2954. Online ahead of print.ABSTRACTIn June 2021, the Food and Drug Administration (FDA) granted accelerated approval to aducanumab, a monoclonal antibody indicated for the treatment of Alzheimer's Disease. The accelerated approval decision was controversial due to concerns about the use of an unvalidated surrogate measure, beta-amyloid, as the basis for approval and a lack of clinical outcome benefit. Between October 2021 and September 2022, we conducted a survey of a nationally representative group of internists, medical oncologists, and cardiologists to understand persp...
Source: Clinical Pharmacology and Therapeutics - May 23, 2023 Category: Drugs & Pharmacology Authors: Sanket S Dhruva Aaron S Kesselheim Steven Woloshin Robin Z Ji Zhigang Lu Jonathan J Darrow Rita F Redberg Source Type: research

Response-Based Dosing for Ponatinib: Model-Based Analyses of the Dose-Ranging OPTIC Study
Clin Pharmacol Ther. 2023 May 23. doi: 10.1002/cpt.2956. Online ahead of print.ABSTRACTOPTIC was a randomized, phase 2 dose-optimization trial of ponatinib in chronic phase-chronic myeloid leukemia (CP-CML) resistant to ≥2 tyrosine kinase inhibitors or with T315I mutation. Patients were randomized to starting doses of 45-, 30-, or 15-mg ponatinib once daily. Patients receiving 45- or 30-mg reduced to 15-mg upon achievement of ≤1% BCR::ABL1IS (≥MR2 response). The exposure-molecular response relationship was described using a 4-state, discrete-time Markov model. Time-to-event models were used to characterize the relati...
Source: Clinical Pharmacology and Therapeutics - May 23, 2023 Category: Drugs & Pharmacology Authors: Michael J Hanley Paul Diderichsen Benjamin Rich Anna Largajolli Emilie Schindler Alexander Vorog Karthik Venkatakrishnan Neeraj Gupta Source Type: research