The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. All adverse events (AEs) that were possibly or probably related to LYT-100 were mild and transient and there were no discontinuations. 1 Cottin, V.,

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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.

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The Pharma Data

JULY 21, 2021

Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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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.

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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.

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The Pharma Data

FEBRUARY 12, 2022

Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times. Gilead Lores,Inc.

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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.

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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.

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Alta Sciences

AUGUST 28, 2023

The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied.

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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.

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The Pharma Data

MARCH 9, 2022

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Pfizer Inc.

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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.

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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.

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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.

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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.

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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].

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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.

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives.

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The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

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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.

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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.

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The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

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The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

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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.

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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.

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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.

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The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. New indications.

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The Pharma Data

MARCH 9, 2021

The primary endpoint was the maximum change in plasma HIV-1 RNA during parts one and two while secondary endpoints measured safety, tolerability, and pharmacokinetic (PK) parameters. There were no adverse events (AEs) leading to discontinuation and no deaths reported. log 10 and -2.0

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The Pharma Data

AUGUST 22, 2021

The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups. Safety, Tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Griffin MP, et al. Yu XQ, et al.

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The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

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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.

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DrugBank

FEBRUARY 26, 2025

Our platform offers an extensive database of drug interactions, molecular targets, and pharmacokinetics, providing researchers with the tools to identify and optimize effective compounds. This capability allows researchers to design synergistic regimens that address multidrug-resistant pathogens.

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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.

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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.

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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.

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The Pharma Data

APRIL 16, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

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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.

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