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Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolite Tales Blog

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. It is proposed that the decreased clearance of the drug observed in patients may be due to depletion of GSH in this population [10]. link] [10] Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T.

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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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Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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MicroED: From Powder to Structure in a Half-Hour

NIH Director's Blog: Drug Development

Now comes word of another absolutely incredible use of cryo-EM: determining with great ease and exquisite precision the structure of the smaller organic chemical compounds, or “small molecules,” that play such key roles in biological exploration and drug development. Also analyzed were eight less-familiar small molecules.

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Concurrent Validation for Breakthrough and Orphan Drugs: Meeting the Needs for Accelerated Manufacturing

The Premier Consulting Blog

In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients.

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Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Conversations in Drug Development Trends

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

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Molecular glues: new solutions for undruggable proteins | BMG LABTECH

BMG Labtech

In this blog, we take stock of progress, look at what’s in store for drug development, and give examples of ways microplate readers can help advance research into molecular glues. Conventional drug development has often focused on finding small molecules that fit the active site of a protein.