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XELOX therapy, which comprises capecitabine and oxaliplatin, is the standard first-line chemotherapeutic regimen for colorectal cancer. Mathematical modeling combining pharmacokinetics (PK) and toxicodynamics (TD) is a promising approach for optimizing dosing strategies and reducing toxicity.
Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drugdevelopment lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades.
Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.
Moreover, smaller companies like Altimmune are seeking partnerships to propel the development of their experimental drugs. As larger players scout for innovative solutions, partnerships with smaller firms offer a pathway to accelerate drugdevelopment and diversify product portfolios.
We also believe that drugdevelopment teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD. MB097, our drug with immune-oncology applications, is a consortium of nine bacterial strains.
My clinical background as a physician led me to drugdevelopment, where I realised I could have an even broader impact on patient well-being. By fostering the fluid movement between research and clinical practice, we can better contribute to the development of therapies, which has been the most rewarding aspect of my career.
s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. 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.
Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.
We also leverage existing clinical gene expression data from different subsets of molecularly profiled cancer patients, who differ in a certain aspect of disease or response to a particular therapy. Author Bio: Brett Hall Brett has been Chief Scientific Officer at Immuneering since November 2019.
This issue poses a significant hurdle for drugdevelopers, with no universal protocol currently in place to address these complexities. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.
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. At Altasciences , we have extensive experience testing various pain models.
The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced.
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.
Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. NEW HAVEN, Conn., BioXcel Therapeutics, Inc.
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. About CG-806.
4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0
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. ” About Hepion Pharmaceuticals.
Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drugdevelopment activities.
Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities. In 2016, the U.S.
FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developingtherapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.
Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. The safety and tolerability of aducanumab was the primary aim of the study. About Alzheimer’s Disease. About Biogen.
” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.
FDA provides extensive examples, citing the common practice of using data from the therapy in a similar, already-approved indication. (2) 2) Mechanistic or pharmacodynamic evidence can be utilized when the disease pathophysiology and drug mechanism are both well-understood and straightforward.
The side effects of some anticancer treatments can result in dose interruptions or de-escalations, or even outright discontinuation of an efficacious therapy. subsequent superior/inferior supportive care, lifestyle changes, or use of additional therapies).
BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drugdevelopment? However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.
Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drugdevelopment (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketed drugs. The Altascientist, Issue 7, pg.
By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drugdevelopment A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Importantly, midomafetamine was proposed for use in conjunction with psychotherapy.
As opposed to the linear dose-response relationships of chemotherapies, the wide therapeutic indexes of many of these newer therapies means that doses can be increased without simultaneously increasing toxicities. Other issues also arise: Unlike conventional cytotoxic drugs where the relationship between early (e.g.,
We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.
TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.
Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. Even under the shadow of the Covid-19 pandemic, 1.2
Identifying a safe and effective dose for registrational trials is one of the most critical and complex aspects of early-stage drugdevelopment for rare diseases. Traditionally, early drugdevelopment focuses on ensuring the safety of clinical doses, with regulatory authorities prioritizing patient protection.
The oncology drugdevelopment landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drugdevelopers who have yet to identify a biomarker, helping them advance their programs effectively.
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