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The rising impact of biomarkers in early clinical development

Drug Target Review

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. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

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. Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S.

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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. Rigorous procedures to ensure that drugs are effective and safe.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality.

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Best-in-Class Solutions Accelerate Development of GLP-1 Therapeutics

PPD

Food and Drug Administrations (FDA) diversity and inclusion in clinical trials mandate. When developing a plan to enroll a representative patient cohort, its important to look at whether your inclusion/exclusion criteria are inadvertently excluding large parts of the population.

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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. More information at www.algotx.com. View source version on businesswire.com: [link].

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Trends in Oncology Study Design, from Optimus to Endpoints

Conversations in Drug Development Trends

His presentation covered various aspects of oncology clinical programs, focusing on study design trends, with reference to both the recently implemented FDA Project Optimus guidance and studies we have seen from sponsors.