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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Compliance Pharmacokinetics Drugs Engineering 100

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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FDA Drugs Pharmacokinetics Production 105

Chemical Biology and Drug Design

MARCH 6, 2024

Abstract Targeting pro-inflammatory cytokines and their production is found to be of therapeutic benefit for the regulation of inflammation in various chronic autoimmune diseases. Computational analysis and in vitro studies corroborated the cytokines (TNF-α, IL-6 and IL-1β) inhibition potential of the new natural molecule polonilignan.

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Pharmacokinetics Regulations Disease Production 100

Elrig

MARCH 25, 2025

After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona). There, he worked with the GENCODE consortium to establish foundational lncRNA gene annotations, which are considered a standard reference in the field.

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RNA Bioinformatics Science Pharmacokinetics 59

Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet]. Available from: [link] 9.Mohanty

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Small Molecule Therapies Regulations Treatment 105

biobide

SEPTEMBER 29, 2023

Nowadays, the development of informatic models and the advances in Artificial Intelligence (AI) allow accurate predictions on complex biological processes such as pharmacokinetics or vast screenings of Drug candidates, based on the prediction of their pharmacological effects.

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Animal Testing Drugs Pharmacokinetics Regulations 106

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

LifeSciVC

APRIL 24, 2024

For KLK5 and KLK7 as well as their endogenous regulator (LEKTI, encoded by SPINK5 ) and one of their substrates (filaggrin, FLG ) there is evidence that KLK5 and 7 up-regulation is pathogenic and down-regulation protective in epidermal barrier dysfunction (especially for Atopic Dermatitis). in the case of CFTR for Trikafta).

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Production Small Molecule Regulations Trials 117

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Trials Clinical Trials Regulations FDA 80

DrugBank

MARCH 7, 2024

Among the notable contenders are: Semaglutide Analogs : Building upon the success of Ozempic, researchers are exploring analogs of semaglutide, the active ingredient in Ozempic, with enhanced potency and improved pharmacokinetic profiles.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 98

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. Neuropsychiatric treatment is on the verge of a major transformation.

Treatment 52

Treatment Licensing Licensing Science 52

Drug Target Review

JUNE 6, 2023

This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

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Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

The Premier Consulting Blog

JULY 31, 2024

Regulatory Pathway 505(b)(2) versus 505(b)(1) In the US, novel new small molecule drug products, including some peptides, are regulated, and approved by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Federal FD&C Act”) under two key regulatory pathways: Section 505(b)(1) and Section 505(b)(2) NDAs.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. Generation by phage display and characterization of drug-target complex-specific antibodies for pharmacokinetic analysis of biotherapeutics.

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Molecular Biology Pharmacokinetics Laboratories Animal Testing 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. This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019.

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Small Molecule Clinical Trials Trials Pharmacokinetics 52

The Pharma Data

MARCH 25, 2022

Artificial intelligence is now used to map evidence and trends in traditional medicine and to screen natural products for pharmacokinetic properties. There has been a rapid modernization of the ways traditional medicine is being studied.

Government 52

Government Science Pharmacokinetics Production 52

Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. It addresses both acute and chronic pain, avoiding the addiction risks associated with opioids.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

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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Small Molecule Clinical Trials Trials Treatment 40

New Drug Approvals

OCTOBER 24, 2023

“The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . ^ June 2019). 369 (3): 311–317. doi : 10.1124/jpet.118.254268.

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FDA FDA Approval International Pharmacokinetics 57

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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Clinical Trials Compliance Trials Laboratories 52

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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Science FDA Clinical Trials Clinical Pharmacology 40

Metabolite Tales Blog

DECEMBER 13, 2023

UGT1A enzymes were shown to be down-regulated in several cancers, and mutations in UGT genes enhance the risk of bladder cancer in smokers [10]. 8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. A route to be avoided or a desired route of metabolism?

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Small Molecule Metabolic Stability Treatment Drugs 59

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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Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Scientists documented a significant depletion of long-lived plasma cells, a reduction of interferon type I activity, and a down-regulation of T-cell transcripts associated with chronic inflammation. Bioelectronic Platform.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

Agency IQ

AUGUST 11, 2023

The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management. In a new contract notice , FDA seeks sources that could furnish “ThinkTrends Software Support for Optical Character Recognition (OCR) PDF Extraction.”

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FDA Compliance Clinical Trials Pharmacokinetics 40

The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

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Clinical Trials Small Molecule Trials Therapies 40

The Pharma Data

DECEMBER 29, 2020

Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. About Fabry Disease. Galactosidase-A enzyme.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

APRIL 11, 2023

A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

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Research Clinical Trials Small Molecule Trials 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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FDA Trials Therapies Regulations 40

Agency IQ

DECEMBER 11, 2023

So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans. A big concern for researchers, IRBs and regulators: Diversity beyond race and ethnicity. And this should be done before pen is put to paper to write a clinical study protocol.”Fashoyin-Aje

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FDA Research Clinical Trials Trials 40

The Pharma Data

MAY 17, 2023

BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia.

FDA Approval 40

FDA Approval Disease Clinical Trials Trials 40

Metabolite Tales Blog

APRIL 4, 2023

Tapinarof is a topical aryl hydrocarbon receptor–modulating agent approved for the treatment of psoriasis by downregulating proinflammatory interleukin-17 and regulating expression of the skin-barrier proteins filaggrin and loricrin. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest. Br J Pharmacol.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

AUGUST 29, 2020

About the Study NCT03439839 is a Phase II, multicenter, open-label, sequential 2-cohort trial to assess the safety, efficacy, tolerability and pharmacokinetics/pharmacodynamics of LNP023 in PNH patients (cohort 1: n=10) with active hemolysis despite treatment with eculizumab.

Treatment 52

Treatment Disease Small Molecule 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

The Pharma Data

OCTOBER 25, 2020

This trial is a multicenter, randomized, double-blind, placebo-controlled, ascending, dose-finding, adaptive Phase 2 study designed to evaluate the safety, pharmacokinetics and efficacy of BXCL501 in intensive care unit patients experiencing agitation associated with delirium, including COVID-19 patients.

Treatment 40

Treatment Trials FDA Hospitals 40

The Pharma Data

APRIL 8, 2021

Applications are under review with numerous regulators. This includes the number of infants able to sit without support for 5 and 30 seconds, a key motor milestone not normally seen in the natural course of the disease, as well as data on event-free survival and reduced hospitalisations. Europe and Japan. About Roche in Neuroscience.

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Clinical Trials Trials Disease Therapies 52