Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. Susan Audino is ISO Assessor and Instructor, Scientific Advisor at AOAC International CASP, and Chemistry Laboratory Consultant at SA Audino & Associates, LLC.

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Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

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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. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. NASH Investor Event Information. About PXL770.

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Alta Sciences

JULY 31, 2024

For many drug developers, this guidance has been long-awaited, as it emphasizes inclusivity of underrepresented and minority populations not only in late-stage clinical trials but throughout the entire clinical process, including early stages. Discover how drug developers, researchers, and regulators are ensuring this happens.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Policy-wise, this is still a work in progress.

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