Alta Sciences

AUGUST 16, 2023

Microsampling for Pediatric Baricitinib Pharmacokinetics shajjar Wed, 08/16/2023 - 19:06 Publication bio-2023-0044_3.pdf pdf Tags Bioanalysis Category Journal Article Weight 1

Pharmacokinetics 40

Pharmacokinetics 40

Drug Patent Watch

DECEMBER 10, 2024

This article will delve into the importance of scientific expertise in generic drug development, highlighting the key areas where scientific knowledge is essential. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

Drug Development 98

Drug Development Pharmacokinetics Compliance Drugs 98

Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Chemical Biology and Drug Design

AUGUST 18, 2024

The drug-like properties (like pharmacokinetics and pharmacodynamics) of the individual scaffolds can be improved by benzimidazole–oxadiazole chimeric molecules via a molecular hybridisation approach. Benzimidazole and oxadiazole cores can either be fused or incorporated using either functional groups/bonds.

Pharmacokinetics 100

Pharmacokinetics Drugs Research 100

Chemical Biology and Drug Design

JANUARY 29, 2024

Abstract In this article, we described synthesis of 1,3-thiazolidine - amide hybrid derivatives by two different methods from ( S )-2-amino-3-(4-(benzyloxy)phenyl)-1-(thiazolidin-3-yl)propan-1-one (4). Quantitative structure toxicity relationship (QSTR) study pointed out the slight toxic nature of compounds.

Pharmacokinetics 100

Pharmacokinetics Production Drugs Research 100

Drug Target Review

APRIL 7, 2025

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Elrig

MARCH 25, 2025

Earlier in her career, she held several leadership roles within AstraZeneca, including Senior Director for Drug Metabolism & Pharmacokinetics and Director for Lead Optimisation & Enabling Technologies within medicinal chemistry. Dr Andersson has authored over 70 peer-reviewed articles and is a named inventor on six patents.

RNA 59

RNA Bioinformatics Science Pharmacokinetics 59

Alta Sciences

FEBRUARY 19, 2025

We use validated bioanalytical solutions using LC-MS, hybridization-based assays, and ligand-binding techniques to drive precise quantification, immunogenicity risk assessment, and informed dose selectioncritical for pharmacokinetics, biodistribution, and safety evaluations. Have questions about your oligonucleotide therapeutic studies?

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

Drug Target Review

DECEMBER 11, 2024

In this article, we share our hard-earned insights into overcoming these critical challenges. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

International 52

International Laboratories Drugs Pharmacokinetics 52

Chemical Biology and Drug Design

DECEMBER 19, 2024

ADMET prediction analysis indicated that compounds 5h and 5k showed good pharmacokinetic properties. Investigation of the mechanism of action indicated that 5k down-regulated NF-B expression, possibly by suppressing LPS-induced expression of the p65 protein.

Pharmacokinetics 100

Pharmacokinetics Regulations Treatment Drugs 100

Chemical Biology and Drug Design

MAY 31, 2023

Finally, in silico results and pharmacokinetic parameters of ADME showed that these compounds have good oral bioavailability properties. According to the docking result, the most stable conformation of AChE and compound 3i showed that it has a binding affinity of −10.82 kcal/moL.

Pharmacokinetics 100

Pharmacokinetics Research 100

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 Drugs Research 100

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

Chemical Biology and Drug Design

MARCH 6, 2024

Thus, polonilignan has been identified as a new pan-cytokine and NO inhibitor, it is recommended to optimise a method for the synthesis of this small molecular weight lignan and explore its pharmacokinetic characteristics, toxicity and therapeutic effect under various chronic inflammatory disease models.

Pharmacokinetics 100

Pharmacokinetics Regulations Disease Production 100

Agency IQ

JULY 28, 2023

Physiologically-based pharmacokinetic (PBPK) models are defined by FDA as drug development tools that mathematically integrate physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug’s absorption, distribution, metabolism, excretion (ADME), and pharmacokinetics (PK).

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Drug Target Review

MARCH 17, 2025

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. This is based on the traditional model of occupancy-driven pharmacology, where a drug’s therapeutic effects are directly related to the time it occupies its target.

Treatment 52

Treatment Licensing Licensing Science 52

Agency IQ

AUGUST 11, 2023

From the contract notice, it appears that the FDA wants to look into using AI to extract data from these reports (see a template here ) to support RRAs.

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

Agency IQ

DECEMBER 1, 2023

While the previous version stated that patients with kidney or liver dysfunction should be enrolled as long as the pharmacokinetics (PK) for the drug in such patients is “adequately understood,” the new guidance is phrased to indicate that, moving forward, the PK in these patients should be understood.

FDA 40

FDA Clinical Trials Trials Vaccine 40

Agency IQ

FEBRUARY 2, 2024

The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. Analysis, and what’s next In general, this guideline is attempting to cover a large amount of regulatory territory in a single document.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Metabolite Tales Blog

APRIL 10, 2024

Note that where Hypha may have been involved in any of the projects described, no details on metabolites other than what is publicly available have been disclosed in this article. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023; 62(12):1765-1779.

Small Molecule 59

Small Molecule FDA Approval FDA Pharmacokinetics 59

Agency IQ

AUGUST 16, 2024

Lykos also registered an additional open-label Phase 1 pharmacokinetics study of midomafetamine and metabolites in patients with moderate hepatic impairment to understand if a dose adjustment is necessary in that population. This study is planned to start in late 2024 and conclude in late 2025.

FDA 40

FDA Trials Therapies Regulations 40

Molecular Design

MAY 11, 2019

I'll examine an article entitled ‘Mapping the Efficiency and Physicochemical Trajectories of Successful Optimizations’ (YL2018) in this post and I should note that the article title reminded me that abseiling has been described as the second fastest way down the mountain.

Metabolic Stability 52

Metabolic Stability Pharmacokinetics Pharmaceuticals Drugs 52

Molecular Design

JULY 18, 2020

I’ve been looking at the published inhibitors shown below in Chart 1 (which exhibit antiviral activity and have been subjected to pharmacokinetic and toxicological evaluation) and have written some notes on mapping the structure-activity relationship for compounds like these. by forming a ring). by forming a ring).

Biochemical Assays 52

Biochemical Assays Fragment Screening Pharmacokinetics Drugs 52

Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings. According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Molecular Design

FEBRUARY 7, 2023

The FDH is covered in the S2010 (see Box 1 and 2) and B2013 articles and, given that the targets of small molecule drugs tend to be intracellular, I’ll direct you to the excellent Smith & Rowland perspective on intracellular and intraorgan concentrations of drugs.

Pharmacokinetics 40

Pharmacokinetics Small Molecule Disease Clinical Trials 40

The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. Forward-Looking Statements.

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Agency IQ

OCTOBER 20, 2023

Obese patients should be included, and pharmacokinetic (PK) parameters for study drugs should be determined prior to phase 3 in both normal-weight and obese patients. Studies should not have an upper age limit for participation, and comorbidities shouldn’t be used as exclusion criteria, barring safety concerns.

FDA 40

FDA Treatment Trials Therapies 40

Agency IQ

DECEMBER 11, 2023

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

FDA 40

FDA Research Clinical Trials Trials 40

Vial

MARCH 15, 2024

This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes. Additionally, the article discusses difficulties inherent in managing clinical trials and emphasizes the indispensable contributions of sponsors in the trial.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

Molecular Design

MARCH 26, 2024

Encountering words like “truth” and “beauty” (here's a good example ) in the titles of scientific articles always sets off warning bells for me and I’ll kick off blogging for 2024 with a look at FM2024 (Structure is beauty, but not always truth) that was recently published in Cell. I disagree with this assertion.

Drugs 60

Drugs Pharmacokinetics Cell Based Assays Treatment 60

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The review under Article 5(3) was separate, but ran in parallel to the rolling review of casirivimab and imdevimab, which is currently ongoing by the EMA. About the Japanese Special Approval for Emergency.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

Metabolite Tales Blog

JANUARY 23, 2024

Where data was publicly available, the routes of metabolism for each drug is listed in Table 1 in the Appendix at the end of this article. Note that where Hypha may have been involved in any of the projects described, no details on metabolites other than what is publicly available have been disclosed in this article. 2] Iversen et al.,

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

PerkinElmer

JUNE 3, 2022

Writing in JACS , the researchers concluded: “Based on the broad-spectrum antiviral effect combined with promising selectivity and in vitro pharmacokinetic profile, the scaffold represented by [this compound] is one of the most promising for development of an antiviral drug targeting SARS-CoV-2.”

Fragment Screening 52

Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52

Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

The Anticancer Fund

APRIL 1, 2022

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. Our intention is to help bring these findings to the attention of the broader cancer research community.

Clinical Trials 40

Clinical Trials Drugs Trials Pharmacokinetics 40

The Anticancer Fund

JUNE 7, 2022

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. This pharmacokinetic study (n=9) compared half-dose erlotinib (75 mg/day) with the HIV drug ritonavir (200 mg/day) with full-dose erlotinib (150 mg/day).

Drugs 40

Drugs Clinical Trials Trials Treatment 40

PPD

JUNE 20, 2023

Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article. And for sponsors, this strategy reduces overhead, in turn offering business continuity, flexibility and potential cost savings. Are your CRO’s services flexible and easily scaled to your needs?

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52