Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

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The Pharma Data

OCTOBER 14, 2020

The new services have been developed to support pre-clinical research by optimizing hiPSC-derived cell culture, while providing high-quality electrophysiological data acquisition and analysis from physiologically relevant human cell models. The funds will be used to bring Ori’s innovative manufacturing platform to the market.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. What if no DAP was provided or implemented for that study based on its initial objectives?

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.

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PPD

JUNE 20, 2023

Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. Bonus: Can your CRO singlehandedly advance your molecule from research to market?

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. For these products, DAPs must be submitted as part of the pre-market request (i.e.,

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Agency IQ

FEBRUARY 2, 2024

However, they may also be used as pivotal trials in marketing authorization applications as long as the standard requirements (e.g., Complex clinical trial designs can pose statistical interpretation challenges. Umbrella trials investigate multiple drugs or drug combinations in one disease. randomized control arms) are met.

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The Pharma Data

DECEMBER 23, 2020

Marketing Authorization was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. Funding efforts were led by Robin Tombs, co-Founder of Yoti and previously of Gamesys, and other angel investors.

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.

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