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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. 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

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development

The Premier Consulting Blog

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. View the Driving Simulation Fact Sheet for more information.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Shifting from pharmacology, the draft guidance offers input on design of toxicology studies.

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Biomarker identification in the realm of rare diseases

Drug Target Review

For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.

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