ASPET

AUGUST 21, 2024

This review details the onset mechanisms of drug-induced TdP, including I Kr inhibition, pharmacokinetic factors, autonomic regulation and reduced repolarization reserve. It also explores the utility of proarrhythmic surrogate markers (J-T peak , T peak -T end and terminal repolarization period) besides QT interval.

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ASPET

NOVEMBER 17, 2023

Quantitative pharmacokinetic models should therefore focus on OCT2/MATE when describing serum creatinine and creatinine clearance modulation by inhibitor drugs and genotype- or disease-related activity changes.

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Pharmacogenetics Pharmacokinetics Disease Drugs 100

biobide

SEPTEMBER 29, 2023

However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.

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Animal Testing Drugs Pharmacokinetics Regulations 106

The Pharma Data

SEPTEMBER 8, 2021

today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. The company will share a total of 23 abstracts, including two oral presentations and one abstract lecture.

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The Pharma Data

NOVEMBER 9, 2021

Data will be presented on the safety and efficacity of Epclusa ® (400 mg sofosbuvir/ 100 mg velpatasvir) in a broad range of people, including those withco-morbidities (PO-0940, 0927).

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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. Each forward-looking statement speaks only as at the date of this press release.

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Pharmacokinetics Treatment Trials Production 52

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.

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The Pharma Data

MARCH 9, 2021

and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK’254). These findings were presented today at the (virtual) 2021 Conference on Retroviruses and Opportunistic Infections (CROI). log 10 and -2.0

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DrugBank

SEPTEMBER 19, 2024

However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges.    Pharmacokinetics of Oral Drugs  Orally administered drugs undergo a series of biochemical processes that can affect their bioavailability and their clinical efficacy.

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Pharmacokinetics Drugs Treatment Disease 82

Drug Target Review

DECEMBER 4, 2024

These include the use of immunogens that are highly expressed, are very immunogenic and are presented to the immune system in pharmacologically relevant conformations to generate appropriate antibodies. A suitable pharmacokinetics profile can be achieved with the addition of half-life extending moieties to the molecule.

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Pharmacokinetics Small Molecule Therapies Engineering 78

The ChEMBL-og

DECEMBER 13, 2023

Relevant parameters depend on the nature of the assay; for example, protein binding assays should include details of any protein sequence variation as well as other biological entities present in the assay (e.g. subcellular fractions). A physicochemical assay.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. ZYTIGA ® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8.

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BMG Labtech

MARCH 11, 2024

In drug development and discovery, ELISAs are useful to quantify drug concentrations in biological samples where they find applications in studies of drug efficacy, pharmacokinetics, and pharmacodynamics. If more analyte is present in the sample, increasing amounts of detection antibody and signaling enzyme bind to the analyte.

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Vaccine Molecular Biology Laboratories Pharmacokinetics 98

The Pharma Data

APRIL 11, 2023

The presentation highlights the synergistic anti-cancer effects of a PSMA (prostate-specific membrane antigen)-actinium-225 conjugate in combination with darolutamide in preclinical prostate cancer models. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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The Pharma Data

JULY 11, 2021

3 These data are being presented at the 2021 European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Krakow, Poland and Madrid, Spain. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. percent and a median reduction of 98.2

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Treatment Pharmacokinetics Disease Production 52

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.”

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Clinical Trials Trials Pharmacokinetics FDA 83

Drug Target Review

NOVEMBER 1, 2023

2,8-10 However, the number of compounds with satisfying pharmacokinetic parameters (PKD) are limited, with most unable to cross the blood-brain barrier or go sufficiently deep into a malignant tumour. Pleotropic Roles of Autotaxin in the Nervous System Present Opportunities for the Development of Novel Therapeutics for Neurological Diseases.

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LifeSciVC

OCTOBER 10, 2024

This presentation marked the most significant clinical disclosure of any CBL-B inhibitor to date, an important moment not only for industry, but for us at HotSpot. That said, two presentations at ESMO in non-small cell lung cancer (NSCLC) were perhaps “green shoots” for the field.

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Drug Target Review

SEPTEMBER 25, 2024

5 Here, the original oncogene is still present but the transdifferentiated cancer cells are less dependent on it. Investigating non-oncogene resistance as a parallel defense mechanism used by cancer cells to evade therapies could therefore present a significant opportunity to address drug resistance more comprehensively.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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DrugBank

MARCH 7, 2024

Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges. Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.

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PPD

JULY 29, 2024

This blog presents examples that demonstrate how AI can be used throughout the drug development process, with a specific focus on patient enrollment. AI has the capability to analyze and forecast the pharmacokinetic (PK) profiles of drugs following their administration.

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The Premier Consulting Blog

APRIL 15, 2024

It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies. For example, if the nonclinical data presented in the PIND briefing document lacks information on the potential toxicity profile of the drug (e.g.,

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The Premier Consulting Blog

JULY 31, 2024

Clinical pharmacology studies include both in vitro studies using human biomaterials and in vivo human studies and are focused on characterizing pharmacokinetics (PK) (e.g., Author: Jayesh Patel , Principal Scientist, Pharmacokinetics

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Drug Target Review

JUNE 6, 2023

In the context of a tumour microenvironment, Tregs are often present in high numbers, preventing an effective immune response to the tumour. 2 After activation by an antigen presenting cell, a T helper cell segregates the cytokines. Some approaches have already reached the clinical trial stage, with others not far behind.

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Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs. These changes can impact staffing requirements throughout the study.

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Trials Clinical Trials Regulations FDA 80

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. A paper by Bran and coworkers from EFPL and the University of Rochester presented ChemCrow, a system for integrating Chemistry capabilities into LLMs. Drug discovery is inherently an MPO problem.

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Drugs Small Molecule Bioinformatics Packaging 141

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

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Treatment FDA Approval Pharmacokinetics FDA 52

The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., patients with renal, hepatic, or cardiovascular concerns).

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Pharmacokinetics Drugs FDA Production 52

The Pharma Data

NOVEMBER 5, 2021

The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

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The Pharma Data

MARCH 5, 2021

The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) Annual Meeting. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. chief medical officer of Loxo Oncology at Lilly. The primary endpoint for Phase 2 is ORR.

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Clinical Trials Pharmacokinetics Trials Therapies 52

The Pharma Data

APRIL 4, 2023

The HCF formulation is presented in the same auto-injector as currently available to patients, aiming for an enhanced yet familiar patient experience. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

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DrugBaron

FEBRUARY 7, 2022

Another common pitfall in medicinal chemistry is optimise one characteristic at once: find super-potent molecules, then try and ‘fix’ the pharmacokinetics and then try and improve the pharmaceutical properties and so on.

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Small Molecule Synthetic Chemistry Pharma Companies Pharmacokinetics 100

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

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline.

Disease 52

Disease Treatment Pharmacokinetics Trials 52

The Pharma Data

NOVEMBER 11, 2020

A (spike) protein present on the viral envelope must bind to a receptor on the surface of the host cell and be activated in order to enter the cell. Viruses work by infecting host cells and hijacking the cell’s replication machinery. This activation is mediated by a human or host cysteine protease, cathepsin L, found in lung and other cells.

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Treatment Small Molecule Virus Pharmacokinetics 52