ASPET

SEPTEMBER 12, 2023

This first-in-human, randomized, double-blind, placebo-controlled study (NCT04497662) evaluated safety, pharmacokinetics, receptor occupancy, and pharmacodynamics of the humanized anti-CD40 monoclonal antibody KPL-404. Nonlinear dose-dependent changes in various pharmacokinetic parameters were identified following the range of IV doses.

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials.

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PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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PPD

SEPTEMBER 19, 2023

As the PPD clinical development business of Thermo Fisher Scientific, we have access to integrated, end-to-end clinical trial support and delivery solutions. What differentiates PPD Early Development services from others in this space? organ impairment, CNS and rheumatology), special populations (e.g.

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Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. 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.

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions. Click to learn more!

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DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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Clinical Trials Trials Treatment FDA 52

ASPET

APRIL 26, 2024

In this study, we investigated the systemic pharmacokinetics and subsequent CNS distribution of two potent HDACIs, vorinostat and quisinostat, in the murine model. A knowledge of CNS exposure (K p,uu ), time to peak, and duration can inform dosing strategies in preclinical and clinical trials in selected CNS tumors.

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The Pharma Data

AUGUST 28, 2020

Celltrion Group has announced that the Korean Ministry of Food and Drug Safety has approved the company’s Investigational New Drug application for a Phase 1 trial for their coronavirus antiviral antibody treatment candidate.

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Trials Treatment Clinical Trials Pharmacokinetics 52

Advarra

JUNE 20, 2023

Typical clinical development timelines for anticancer drugs average an estimated 6.7 Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec.

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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.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.

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Clinical Trials Trials Pharmacokinetics FDA 83

Alta Sciences

FEBRUARY 19, 2025

The guidance ensures that these targeted evaluations help identify and mitigate safety concerns early in the development process, supporting the safe progression of oligonucleotide therapies into clinical trials.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

The Pharma Data

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. About ALS-4.

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Small Molecule Clinical Trials Trials 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.

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DrugBank

MARCH 7, 2024

Moreover, Novo Nordisk and Eli Lilly are expected to unveil new clinical trial data that could highlight additional health benefits of their drugs beyond weight loss and diabetes management, potentially paving the way for broader insurance coverage.

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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 primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

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Drug Target Review

DECEMBER 11, 2024

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

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Drug Target Review

JUNE 6, 2023

However, the protein’s preclinical promise has not yet been replicated in clinical trials, where systemic administration is associated with dose-limiting toxicities and a narrow therapeutic index. Some approaches have already reached the clinical trial stage, with others not far behind.

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Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now. Watch it now.

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Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. The organoid technology recreates different disease scenarios in addition to the healthy models with age specific phenotypes and enables recreating drug specific Pharmacokinetics that is more relevant to human in vivo system.

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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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Trials Clinical Trials Pharmacokinetics Small Molecule 40

Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

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The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

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Packaging Pharmacokinetics Small Molecule Clinical Trials 52

New Drug Approvals

OCTOBER 14, 2024

Avenciguat is under investigation in clinical trial NCT05282121 (A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)). .;

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Pharmacokinetics Disease Trials Clinical Trials 57

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

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PPD

MAY 11, 2023

To effectively implement vaccine clinical trials for special populations, it is critical for vaccine developers to partner with a contract research organization (CRO) that has demonstrated experience recruiting and retaining pediatric and elderly study participants — and managing the nuances these patients and their caregivers require.

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Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Drug Target Review

OCTOBER 24, 2023

We identified these species as being important for treatment of UC by generating and analysing metagenomics data from a Faecal Microbiota Transplant (FMT) trial that was undertaken at the University of Adelaide. In addition to analysing metagenomics data, we also isolated bacteria from the healthy donor stool banked as part of that trial.

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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. Islatravir Safety Analysis Through Week 96 from a Phase 2 Trial in Treatment Naïve Adults with HIV-1 Infection.

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The Pharma Data

AUGUST 30, 2021

A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. Yancopoulos, M.D., President and Chief Scientific Officer at Regeneron. “ In 2016, the U.S.

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Trials Disease Treatment Clinical Trials 52

DrugBank

APRIL 3, 2025

Despite this significant commitment of time and resources, many drug candidates fail in clinical trials, with safety and toxicity concerns being one of the leading causes. Historically, many drug candidates have been discontinued during late-stage clinical trials due to unforeseen toxicities.

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New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. PMC 10540057. PMID 37768671. Diep, John K.; Yu, Rosie Z.; Viney, Nicholas J.; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al.

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