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The rising impact of biomarkers in early clinical development

Drug Target Review

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD). For use as endpoints, biomarkers must be correlated to a valid clinical outcome.

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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. food effect, smoking, and drug-drug interactions) on drug exposure and response.

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Shaping drug development success: how does artwork play a role?

Drug Target Review

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies.

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Trends & Insights: Spotlight Winter Edition

DrugBank

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. DrugBank Powered Research: Pharmacological knowledge about drug targets was analyzed based on a query of DrugBank. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science 40
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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

In between, panelists and presenters also discussed alternative designs for dose-finding trials and creative strategies for evaluating and modeling early clinical data. I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology.

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