Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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Drug Target Review

SEPTEMBER 25, 2024

2022 Dec 12 [cited 2024 Sep 4];22(3):213–34. 2019 Dec 13 [cited 2024 Sep 4];122(4):465–72. 2020 Dec 1 [cited 2024 Sep 4];20(12):743–56. 2021 Oct 11 [cited 2024 Sep 4];13(20):5081. 2021 Apr [cited 2024 Sep 4];2(4):377–91. 2024 Mar 22 [cited 2024 Jul 8];84(6_Supplement):5891–1. Available from: [link] 2.Bell

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thought leadership

DECEMBER 10, 2024

On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms.

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Fierce BioTech

MAY 1, 2024

Join us on Monday, June 19, 2024 for one hour all about oral cyclic peptide drug development. With “specialized for peptide” drug metabolism and pharmacokinetics (DMPK) and biological evaluation, we’re able to solve certain synthesis issues found across different cyclic peptides, complexes peptides and mimetic peptides.

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Alta Sciences

SEPTEMBER 27, 2024

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.

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DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. As we step into 2024, the momentum is expected to continue, with analysts projecting the weight loss drug market to reach remarkable heights, potentially hitting $100 billion by the end of the decade.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. July 31, 2024. [ii] 89 FR 61474.

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LifeSciVC

OCTOBER 10, 2024

However, the data presented at ESMO 2024 showed that the combination of belrestotug with a PD-1 inhibitor led to an encouraging 30% improvement in ORR compared with anti-PD-1 alone. The second presentation of note was the Phase 2 data for relatlimab , an inhibitor of LAG3, another checkpoint receptor, in patients with NSCLC.

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Alta Sciences

OCTOBER 15, 2024

Up Close and Personal with Jason Boehme, Associate Director, Program Management nbartlett Tue, 10/15/2024 - 09:00 Jason Boehme joined Altasciences in 2018 as Senior Project Manager. Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies.

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Common Sense for Drug Policy Blog

JUNE 24, 2024

The structure differs depending on the lipophilicity and steric expansion, which affects the pharmacokinetic aspects, but also the key interaction with monoamine transporters (MATs) in the central nervous system [ 112 , 113 ]. dwf_admin Mon, 06/24/2024 - 19:49 Source Kuropka, P., Zawadzki, M. & Szpot, P.

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Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Antibodies to watch in 2024. 2024 Jan 5;16(1). Generation by phage display and characterization of drug-target complex-specific antibodies for pharmacokinetic analysis of biotherapeutics.

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Metabolite Tales Blog

FEBRUARY 16, 2024

Eur J Drug Metab Pharmacokinet 48 , 411–425 (2023). January 12, 2024. Metabolism and Disposition of the Novel Oral Factor XIa Inhibitor Asundexian in Rats and in Humans. Cuyckens F, Hvenegaard MG, Cassidy KC et al. Recommendations on multiple label use in human ADME. Drug Metab.

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Alta Sciences

AUGUST 12, 2024

Metabolic Drug Development: A to Z Solutions blussier Mon, 08/12/2024 - 18:07 HTML In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential. We support data management both at our clinics and at external sites.

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Alta Sciences

SEPTEMBER 12, 2024

Case Study: Innovative Nanosuspension Approach to Maximize API Potency in Preclinical Formulation Development aasimakopoulos Thu, 09/12/2024 - 20:51 Download a copy of this case study. Client Study Overview A client approached us with the need to get their API BSC Class II compound through the preclinical formulation development phase.

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Alta Sciences

AUGUST 28, 2023

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. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied.

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Drug Target Review

OCTOBER 8, 2024

The OncoOne team is engineering antibodies to optimize pharmacokinetics, biodistribution, tumour retention, and target specificity. Pharmacokinetics and Dosimetry Studies for Optimization of Pretargeted Radioimmunotherapy in CEA-Expressing Advanced Lung Cancer Patients. 2015 Nov 27 [cited 2024 Sep 27];2.

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New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] Aticaprant is taken by mouth. [1]

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Drug Target Review

JULY 1, 2024

SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. Scientific Reports 14, 11103 (2024). He was bestowed the 2024 NIH HEAL Director’s Trailblazer Award for this work. Reference 1 Bazan H A, et al.

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Molecular Design

MARCH 26, 2024

With apologies to Manfred Eigen (1927 - 2019) I've just returned to Cheshire from the Caribbean and, to kick off blogging from 2024 I'll share a photo of the orchids at Berwick-on-Sea on the north coast of Trinidad. Conclusion The authors assert: In drug discovery, truth is a molecule that transforms the practice of medicine. [I

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. The agency issued a new draft guidance on DAPs in June 2024, several months after the Congressional deadline had passed.

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Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.

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Agency IQ

DECEMBER 1, 2023

Now, the FDA has issued its first post-PHE version of this guidance Although the previous version of the guidance was revised to remain in effect until March 7, 2024, it has now been replaced. In addition, the guidance suggested that sponsors conduct antibody testing throughout the study to identify asymptomatic cases.

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Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES | FEB 21, 2024 7:48 PM CST Background: Dose-finding in oncology Traditionally, early development of oncology products has focused on identifying the maximum tolerated dose (MTD) of an investigational product. . …

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Agency IQ

MAY 17, 2024

BY RACHEL COE, MSC | MAY 10, 2024 5:19 PM CDT Generic Drug User Fee Amendments (GDUFA) III The Generic Drug User Fee Agreement (GDUFA) was first passed in 2012 as part of the FDA Safety and Innovation Act (FDASIA) to bolster FDA’s resources for the review and approval of generic drugs.

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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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Agency IQ

DECEMBER 11, 2023

What to look for in 2024: This year, OCE amassed a significant volume of feedback from its advisory committee members and from stakeholders via the rulemaking process on trial design. What to expect in 2024? As AgencyIQ stated previously , this point is well-aligned with the goal of OCE’s Project FrontRunner.

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Alta Sciences

DECEMBER 31, 2024

The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsors investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated. The FDA, 2024 FDA guidance M12 Drug Interaction Studies , pg.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. Researchers must characterize the anti-drug-antibody (ADA) response in preclinical and clinical studies and report any ADA-positive samples as a risk-based approach.

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. § Basis at 18; NPRM at 44,605.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity. “We

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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. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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The ChEMBL-og

APRIL 16, 2024

Data set retrieved on 09/02/2024. For legacy AUC and Cmax records (< ChEMBL 34), pharmacokinetic parameters have been extracted from the assay descriptions using regular expression matching (RegEx). We are delighted to announce the release of ChEMBL 34, which includes a full update to drug and clinical candidate drug data.

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Agency IQ

AUGUST 16, 2024

By Rachel Coe, MSC | Aug 12, 2024 6:15 PM CDT Background For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology. In this analysis, AgencyIQ has combed through the newly released final guidance document to tease out what’s new and what’s the same.

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Sygnature Discovery

NOVEMBER 29, 2023

The QN-302 Phase 1 clinical trial is a multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. They anticipate providing an update on safety and preliminary efficacy of the Phase 1a study in the first half of 2024.

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Sygnature Discovery

NOVEMBER 29, 2023

The QN-302 Phase 1 clinical trial is a multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. They anticipate providing an update on safety and preliminary efficacy of the Phase 1a study in the first half of 2024.

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