ASPET

JUNE 10, 2024

The objective of this study was to evaluate the systemic pharmacokinetics and mechanisms that influence the CNS distribution of WSD0628, a novel and potent ATM inhibitor, in the mouse. Thus, WSD0628 has favorable pharmacokinetic properties and potential for further exploration to determine the PK-PD-efficacy relationship in CNS tumors.

Pharmacokinetics 40

Pharmacokinetics Pharmacogenetics Treatment DNA 40

ASPET

JULY 15, 2024

Mathematical modeling combining pharmacokinetics (PK) and toxicodynamics (TD) is a promising approach for optimizing dosing strategies and reducing toxicity. XELOX therapy, which comprises capecitabine and oxaliplatin, is the standard first-line chemotherapeutic regimen for colorectal cancer.

Pharmacokinetics 40

Pharmacokinetics Therapies Drugs Treatment 40

Alta Sciences

JUNE 24, 2023

Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug lperez Sat, 06/24/2023 - 08:07 Publication Altasciences_WRIB_2023_Design_and_Validation_of_a_Bioanalytical_Method_to_Support_a_Clinical_Pharmacokinetic_Study.pdf Tags Bioanalysis Date of publication (..)

Pharmacokinetics 40

Pharmacokinetics Drugs 40

Drug Discovery World

JUNE 26, 2024

The study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult AD participants. Spinogenix has initiated a Phase II trial to evaluate SPG302 for the treatment of adult participants with mild-to-moderate Alzheimer’s disease (AD), following approval for the trail in Australia.

Small Molecule 189

Small Molecule Pharmacokinetics Clinical Trials Drugs 189

Broad Institute

JULY 17, 2024

Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function. Drug developers also assess pharmacokinetic effects, or how an organism absorbs, distributes, metabolizes, and clears a drug.

Pharmacokinetics 80

Pharmacokinetics Molecular Biology Drugs FDA 80

Drug Discovery World

SEPTEMBER 28, 2022

Measuring the pharmacokinetics of monoclonal antibodies. Learn about the critical role analytical tools and equipment have in helping to advance drug discovery research in this DDW ebook sponsored by Sartorius. This ebook covers: Opinions on the major trends in lab analytics. Best practices in cell line development. Access the eBook here.

Pharmacokinetics 130

Pharmacokinetics Drugs Research 130

Drug Discovery World

JULY 24, 2024

ETD001 has already demonstrated an excellent safety profile in healthy participants, as well as a pharmacokinetic (PK) profile consistent with a long lung residency. We look forward to progressing ETD001 through Phase II trials and beyond.”

Clinical Trials 130

Clinical Trials Trials Pharmacokinetics Regulations 130

Drug Discovery World

OCTOBER 2, 2023

The EC decision is based on the results from the Phase III ASCERTAIN clinical trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients.

Treatment 130

Treatment Pharmacokinetics Clinical Trials Licensing 130

Drug Discovery World

OCTOBER 30, 2023

FIT-001 is a first-in-human, multicentre, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of KO-2806 when administered as monotherapy and in combination with targeted therapies.

Trials 130

Trials Pharmacokinetics Therapies Treatment 130

Drug Discovery World

DECEMBER 5, 2023

Download the guide to learn more about:  How JAX’s HuPK™ Humanised FcRn Platform offers a validated and cost-effective solution for assessing the in vivo  preclinical pharmacokinetics and stability of Fc-based biologics and therapeutics carried by albumin.   JAX’s portfolio of FcRn humanised mouse models. 

Pharmacokinetics 130

Pharmacokinetics Drugs Drug Development Disease 130

Drug Discovery World

MAY 11, 2023

They are chemically synthesisable, featuring a low molecular weight and tunable pharmacokinetics, with a large surface-area for molecular interactions that allows protein-protein interactions to be targeted. The two companies will jointly use Bicycle’s peptide technology to develop bicyclic peptides for several oncology targets.

Pharmacokinetics 244

Pharmacokinetics Clinical Development Drugs Research 244

Drug Discovery World

MARCH 15, 2024

The study concluded that EXN407 met all pharmacokinetic and safety parameters, as well as showing encouraging signs of biological activity. The Phase IIb study is planned to initiate in 2024, following the successful completion of the company’s Phase Ib/IIa trial for EXN407.

Clinical Trials 130

Clinical Trials Trials Pharmacokinetics Clinical Development 130

Drug Discovery World

APRIL 10, 2023

Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery, a reproducible and dose-linear pharmacokinetic profile, and a reliable induction of profound psychedelic experiences.

Pharmacokinetics 130

Pharmacokinetics FDA Approval Hospitals Treatment 130

Drug Discovery World

DECEMBER 5, 2023

Study design templates, expected results, and troubleshooting tips for the most common applications of JAX’s HuPK™ Platform.  

Pharmacokinetics 130

Pharmacokinetics Laboratories Drugs Disease 130

Drug Discovery World

DECEMBER 22, 2023

The trial met all pharmacokinetic objectives, so the company plans to progress the candidate into further clinical development and will meet with the US Food and Drug Administration (FDA) at a Pre-IND meeting in the first half of 2024.

Pharmacokinetics 130

Pharmacokinetics Clinical Development Trials FDA 130

Drug Patent Watch

OCTOBER 30, 2023

Over the past two decades, Bayer Pharma has developed an in silico absorption, distribution, metabolism, and excretion (ADMET) platform with the aim of generating models for various pharmacokinetic and physicochemical… The post Advancements in In Silico ADMET Modeling: A 20-Year Journey of Machine Learning in Drug Discovery at Bayer Pharma appeared (..)

Pharmacokinetics 111

Pharmacokinetics Drugs 111

Drug Discovery World

APRIL 8, 2024

Beyond its therapeutic potential and pharmacokinetic attributes, including over 60% oral bioavailability, compound 11c exhibits hepatocyte and plasma stability, minimal cytotoxicity, and low cytochrome P450 inhibition. This action, targeting both inflammation and fibrosis, is a promising step forward in treating MASH.”

Disease 130

Disease Treatment Pharmacokinetics Clinical Trials 130

Drug Discovery World

NOVEMBER 10, 2023

SNS-101, VISTA-blocking monoclonal antibody Sensei Biotherapeutics presented clinical dose escalation data from a Phase I/II study of its SNS-101 monotherapy, which showed well tolerated safety profile, potentially best-in-class pharmacokinetics, and encouraging cytokine release profile across multiple dose cohorts.

Pharmacokinetics 130

Pharmacokinetics Clinical Trials Immune Response Treatment 130

Drug Discovery World

AUGUST 23, 2022

The MAA is supported by results from a Phase III clinical trial investigating the pharmacokinetic (PK) exposure equivalence of the novel oral fixed-dose combination versus IV decitabine. Orally administered decitabine and cedazuridine showed an exposure equivalence to a standard five-day regimen of IV decitabine. References . ?

Treatment 130

Treatment Pharmacokinetics Clinical Trials DNA 130

Drug Discovery World

FEBRUARY 27, 2024

The Phase I clinical trial of ARV-102 will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARV-102, including the evaluation of LRRK2 degradation and exploratory LRRK2 pathway biomarkers. In non-human primates, orally administered ARV-102 has been shown to reach deep-brain regions and degrade LRRK2 by nearly 90%.

Trials 130

Trials Disease Clinical Trials Pharmacokinetics 130

Drug Discovery World

MARCH 8, 2024

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3002 in healthy participants and participants with mild to moderate asthma. IL-4 receptors mediate the IL-4 signalling (both type 1 and type 2) and the IL-13 signalling (type 2).

Trials 130

Trials Pharmacokinetics Clinical Trials Clinical Development 130

Drug Discovery World

NOVEMBER 3, 2023

The Phase I/II trial is a multicentre, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adults with advanced or metastatic solid tumours.

Pharmacokinetics 130

Pharmacokinetics Clinical Trials Trials Disease 130

Drug Discovery World

FEBRUARY 14, 2024

“We believe the data showing complete restoration of motor function in a therapeutic model are remarkable and further support the potential of GT-02287 to slow or stop the progression of Parkinson’s disease, a disease for which only symptomatic treatments are available to patients at this time,” said Matthias Alder, Gain Therapeutics’ Chief Executive (..)

Disease 147

Disease Clinical Trials Pharmacokinetics Trials 147

Drug Discovery World

SEPTEMBER 28, 2022

Measuring the pharmacokinetics of monoclonal antibodies. . The latest DDW eBook reveals the critical role analytical tools and equipment have in helping to advance drug discovery research. It is sponsored by Sartorius. . This ebook covers: . Opinions on the major trends in lab analytics. . Best practices in cell line development. .

Pharmacokinetics 130

Pharmacokinetics Drugs Research 130

Drug Discovery World

JULY 25, 2023

The section on ‘clinical pharmacology considerations’ covers the physiological differences in paediatric patients that can be attributed to pharmacokinetics and pharmacodynamics of the compound/drug of interest. Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

SCIENMAG: Medicine & Health

NOVEMBER 1, 2023

A small clinical trial with a pharmacokinetic sub-study, led by a world-renowned pharmacologist at the University of Houston, has demonstrated the promising effectiveness of the drug Riluzole for improving functionality in people with acute spinal cord injuries (SCI) if the drug is taken within 12 hours post-injury.

Clinical Trials 86

Clinical Trials Trials Pharmacokinetics Drugs 86

Drug Discovery World

FEBRUARY 13, 2024

It has demonstrated efficacy in in vitro and in vivo models of fibrosis, as well as favourable safety and pharmacokinetic profiles in Phase I clinical studies. AM1476 is a selective peripheral-acting 5-HT2B receptor small molecule antagonist that can be delivered orally.

Disease 130

Disease Treatment Small Molecule Pharmacokinetics 130

Drug Discovery World

DECEMBER 4, 2023

The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs. Existing pharmacotherapies lack the rapid onset and peak levels of nicotine delivery to effectively alleviate cravings and withdrawal symptoms during a quit attempt.

Therapies 130

Therapies Treatment Pharmacokinetics Clinical Development 130

Drug Discovery World

JANUARY 10, 2024

Early studies of AIO-001 have shown initial safety, tolerability, pharmacokinetics, and biological activity in healthy volunteers and asthma patients. Targeting the TSLP pathway addresses a key driver of the inflammatory response in major allergic and inflammatory diseases.

Pharmacokinetics 130

Pharmacokinetics Licensing Licensing Clinical Development 130

Drug Discovery World

OCTOBER 25, 2023

The second, dose-expansion, phase of the study (Phase Ib) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase II dose. The study is designed to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended Phase II dose.

Pharmacokinetics 130

Pharmacokinetics Trials Drugs Clinical Trials 130

Chemical Biology and Drug Design

MARCH 7, 2024

The physicochemical, pharmacokinetic, drug-like, and drug-score features of all synthesized compounds were assessed using the online Swiss ADME and Protein Plus software. AutoDock 4.2 was used for their in silico screening against AMPA (-amino-3-hydroxy-5-methylisoxazole) receptor (PDB ID:3m3f). kJ/mol, respectively.

Pharmacokinetics 100

Pharmacokinetics Research Drugs 100

Chemical Biology and Drug Design

JANUARY 29, 2024

In-silico ADME studies significant values of pharmacokinetic parameters and demonstrated good drug like characteristics based on Lipinski's rule of five. In addition, the QSTR study of new compounds were carried out with the help of Toxicity Estimation Software Tool (T.E.S.T). The results showed slight toxic nature of new compounds.

Pharmacokinetics 100

Pharmacokinetics Production Drugs Research 100

Drug Discovery World

MARCH 15, 2024

The Phase Ib study examined the safety, tolerability and pharmacokinetics of twice-daily oral doses of ALX-001 in 32 heathy adult participants aged 50-80. The findings were presented at the AD/PD 2024 Conference in Lisbon. Study results show that ALX-001 was safe in cognitively normal older adults at all tested doses.

Disease 130

Disease Trials Small Molecule Pharmacokinetics 130

Drug Discovery World

FEBRUARY 2, 2024

The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoural activity of OT-A201.

Pharmacokinetics 130

Pharmacokinetics International Drugs Clinical Trials 130

Drug Discovery World

AUGUST 10, 2023

COV-X also demonstrated a superior drug metabolism and pharmacokinetics (DMPK) profile to nirmatrelvir. In five of the six samples dosed with COV-X at 200mg/kg, viral load in the lungs was below the limit of detection. Even at doses five times lower than nirmatrelvir, COV-X provided protection from lung damage.

Immune Response 130

Immune Response Pharmacokinetics Vaccine Drugs 130

Chemical Biology and Drug Design

MARCH 5, 2024

The potent compounds 5d , 5e , and 5f were subjected to in silico pharmacokinetic assessment by SWISS, ADME, and pkCSM. In addition to this, molecular docking studies of compounds 5d , 5e , and 5f demonstrated that these compounds had more EGFR-binding interactions.

Pharmacokinetics 100

Pharmacokinetics Drugs Research 100

Drug Discovery World

JANUARY 31, 2024

Support for danegapitide’s potential With safety data derived from over 500 clinical trial participants, robust toxicology data, and strong non-clinical in vitro and in vivo efficacy results, there is strong support for danegaptide’s potential to address the clinical core ocular pathologies of vascular leakage and capillary breakdown.

Treatment 130

Treatment Clinical Trials Pharmacokinetics Trials 130