Remove Clinical Development Remove Information Remove Pharmacokinetics
article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

The context of use (COU) of biomarker assays must be firmly established, clearly and comprehensively citing how they should be used, and the regulated product development and review-related purpose of that use. That requires taking every possible step to characterise dosage and physiological responses.

article thumbnail

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinical development, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Amgen Unveils Phase 2 Obesity Trial Results for Monthly Maritide at ADA’s 85th Scientific Sessions

The Pharma Data

In tandem with the Phase 2 results, Amgen also shared detailed data from its Phase 1 Pharmacokinetics Low Dose Initiation (PK-LDI) study. This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit.

article thumbnail

Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Conversations in Drug Development Trends

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Continuous feedback loops , like embedding Plan-Do-Check-Act (PDCA) cycles, foster iterative improvements and ensure sustainable outcomes.

article thumbnail

argenx Advances ARGX-119 for Congenital Myasthenic Syndromes

The Pharma Data

Promising Results from Phase 1b Trial The Phase 1b study was a multicenter, randomized, double-blind, placebo-controlled clinical trial specifically designed to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of ARGX-119 in individuals with DOK7-related CMS.

article thumbnail

Navigating Regulatory Hurdles in Drug Development

DrugBank

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. These submissions contain comprehensive data on clinical efficacy, pharmacokinetics, pharmacodynamics, and risk-benefit assessments.

article thumbnail

Challenges and Solutions to Drug-Drug Interactions for Clinical Development

DrugBank

The complexity of pharmacokinetics and pharmacodynamics, coupled with the variability in patient populations, makes predicting and managing DDI a particularly challenging aspect of drug development.  The most clinically significant pharmacokinetic interactions are often those that influence drug metabolism.