DrugBank

OCTOBER 17, 2024

Computational chemistry and molecular modeling techniques can predict potential drug candidates' binding affinity and pharmacokinetic properties, enabling the selection of the most promising compounds for further development.

Drug Development 98

Drug Development Metabolic Stability Clinical Trials Drugs 98

PPD

JULY 29, 2024

AI can also predict the likelihood of a serious adverse event before administering the investigational product at an individual level, allowing patients to be categorized by their risk profile. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Conversations in Drug Development Trends

DECEMBER 20, 2023

However, these types of trials can lead to small, non-comparative safety data sets and do not have the ability to use time-to-event endpoints. Biomarker Endpoints Biomarker endpoints are another helpful way to assess the potential efficacy of both initial dose-finding studies and dose-optimization studies.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. Safety and Pharmacokinetics of Islatravir in Study Participants with Severe Renal Insufficiency. Abstract 2361.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

JANUARY 31, 2021

The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of intravenously administered PNT001 in healthy adult volunteers. Three non-serious Grade 1 adverse events were determined to be related to PNT001 or placebo, and all resolved without sequelae.

Pharmacokinetics 52

Pharmacokinetics Disease Treatment Therapies 52

Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? ISM6331 is a Pan-TEAD inhibitor with novel scaffold with good IP space, discovered by Chemistry42.

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

DrugBank

APRIL 3, 2025

These studies typically include in vitro assays to evaluate cytotoxicity and in vivo models to study pharmacokinetics, pharmacodynamics, and toxicological profiles. These models are further enhanced by integrating data from DrugBank, which provides annotations of drug metabolism and pharmacokinetics.

Drug Development 52

Drug Development Drugs Clinical Trials Pharmacokinetics 52

LifeSciVC

APRIL 24, 2024

If adverse events are anticipated, it is important to understand gene dosage for such an effect (e.g., The ideal target is one where modulation will not drive adverse phenotypes in healthy individuals, which is important if one intends on trialing in healthy volunteers in Phase 1 but also gives comfort for chronic target modulation.

Production 117

Production Small Molecule Regulations Trials 117

Alta Sciences

AUGUST 12, 2024

We’ve conducted numerous pharmacodynamics and immunogenicity assessments, including high-glycemic load challenge/tolerance tests, glucose clamps, insulin-induced hypoglycemic events in type 1 diabetes, and anti-drug antibody evaluations. We support data management both at our clinics and at external sites.

Drug Development 40

Drug Development Clinical Trials Pharmacokinetics Drugs 40

The Pharma Data

MARCH 13, 2021

1 Most treatment-emergent adverse events (98.5%) were mild to moderate in severity. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.

Treatment 52

Treatment Pharmacokinetics Drugs Therapies 52

Drug Target Review

SEPTEMBER 25, 2024

At TOLREMO, we have developed a proprietary modular phenotypic screening platform that leverages transcriptional reprogramming events associated with non-genetic resistance to deliver new chemical scaffolds and identify novel resistance regulators. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet].

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Vial

MARCH 15, 2024

Examples of vendors include: Laboratories : CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others. These collaborations with external vendors are aimed at accessing specialized expertise, technologies, or resources that they may not have in-house.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78. Harth S, Ten Haaf A, Loew C, et al.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

Hospitals 52

Hospitals Pharmacokinetics Treatment Trials 52

DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. Animal Models In vivo studies in animal models assess drug activity, pharmacokinetics, and safety in a living organism.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

The Pharma Data

JANUARY 19, 2021

The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About ALS-4.

Small Molecule 52

Small Molecule Clinical Trials Trials Pharmacokinetics 52

The Pharma Data

JUNE 28, 2021

Part A evaluated the single- and multiple-dose pharmacokinetic and pharmacodynamic properties of Xarelto while Part B evaluated the comparative safety and efficacy of Xarelto versus aspirin when used for thromboprophylaxis for 12 months. UNIVERSE was conducted in two parts.

FDA 52

FDA Clinical Trials Treatment Therapies 52

The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

Small Molecule 40

Small Molecule Clinical Trials Trials Treatment 40

The Pharma Data

SEPTEMBER 7, 2021

Volunteers will be closely monitored for several weeks on inpatient units at Columbia University Irving Medical Center and at Clinilabs to look for adverse events and determine their response to oxycodone after vaccination, before studying their drug behavior on an outpatient basis. The study plans to enroll up to 45 volunteers.

Clinical Trials 52

Clinical Trials Vaccine Trials Medical Schools 52

Advarra

JUNE 20, 2023

Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements. Assessing Endpoints A final hurdle faced in oncology trials is trial endpoints, or the event(s) or outcome(s) being measured to determine whether the study intervention is safe and effective.

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

AUGUST 19, 2021

The majority of treatment-related adverse events (AEs) were Grade 1-2. All events were Grade 1-2. 1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) as the primary endpoint. 1 The median time to first response was 4.1 months (range, 1.6–9.9).

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec. Source link.

Clinical Trials 40

Clinical Trials Trials Pharmacokinetics Clinical Development 40

The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. Serious, including fatal, hemorrhagic events can occur with Retevmo. 3 hemorrhagic events occurred in 2.3% of patients treated with Retevmo.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

OCTOBER 14, 2021

Presentations at ECTRIMS include: IgG Immune Response to SARS-CoV-2 Vaccination in People Living With Multiple Sclerosis Within MS PATHS (P652) Flushing and Flushing-Related Adverse Events With Diroximel Fumarate in Patients With Relapsing-Remitting Multiple Sclerosis: Results from the Phase 3 EVOLVE-MS-2 Study (P673) Early Data Suggest Diroximel Fumarate (..)

Vaccine 52

Vaccine Therapies Immune Response Disease 52

The Pharma Data

AUGUST 29, 2020

LNP023 also demonstrated a favorable safety and tolerability profile with no serious treatment-related infections or thromboembolic events. Following the cut-off date for the presented data, one participant, who had severe lymphopenia at study entry, discontinued treatment due to a serious adverse event (AE) of lymphoproliferative disorder.

Treatment 52

Treatment Disease Small Molecule Production 52

Drug Target Review

JULY 1, 2024

SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

DECEMBER 29, 2020

PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. mL/min/ 1.73m 2 in males, and 86.14 mL/min/ 1.73m 2 in females and plasma lyso-Gb 3 mean levels were 51.81 nM and 13.81

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JULY 22, 2021

No new risks were identified, with no serious adverse events related to rVWF reported. 1 The pharmacokinetics (PK) of VWF:ristocetin cofactor (VWF:RCo) and FVIII pharmacodynamics (PD) [PB0917] were also studied and presented at the congress. The sABR was reduced by 91.5% About von Willebrand Disease (VWD). Adverse Reactions.

Treatment 52

Treatment Laboratories Production Disease 52

DrugBank

DECEMBER 13, 2024

Leafy green vegetables, abundant in vitamin K, can antagonize the anticoagulant effects of warfarin by interfering with its mechanism of action, potentially leading to thromboembolic events such as deep vein thrombosis or pulmonary embolism.

Drugs 52

Drugs Science Treatment Pharmacokinetics 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. NASH Investor Event Information. A live webcast of the event will be available on Poxel’s website at [link] under Events.

Trials 40

Trials Disease Treatment Pharmacokinetics 40

The Pharma Data

JULY 11, 2021

None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay.

Treatment 52

Treatment Pharmacokinetics Disease Production 52

The Pharma Data

JULY 27, 2021

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

Production 52

Production Clinical Trials Government Disease 52

Agency IQ

AUGUST 11, 2023

As a result of these RRAs, we’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions.” ( Emphasis added ).

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

The Pharma Data

SEPTEMBER 19, 2020

2.80] in the PD-L1 positive population, based on 21% of patients with an event; updated HR=1.12 [95% CI: 0.76-1.65]), 1.65]), updated analysis based on 41% of patients with an event). Secondary endpoints include OS, event-free survival, disease-free survival and quality of life measures.

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52