The Premier Consulting Blog

APRIL 3, 2024

The ICH Q14 guideline describes principles to support change management of analytical procedures based on risk management, comprehensive understanding of the analytical procedure, and adherence to predefined criteria for performance characteristics. Pharmaceutical Development Q8(R2). ICH Harmonised Guideline. ICH Harmonised Guideline.

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Pharmaceuticals Cell Based Assays Production International 52

Drug Target Review

OCTOBER 24, 2024

Data-driven discovery As with many early-stage biotech companies, Five Alarm Bio is highly data-driven, producing vast amounts of experimental data through cell-based assays and phenotypic screening.

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Cell Based Assays Science Disease Doctors 52

The Pharma Data

OCTOBER 15, 2020

ASLAN003 is a highly selective and potent inhibitor of human DHODH (IC 50 = 35 nM) and has been shown to be more than 30 times more potent at inhibiting the DHODH enzyme in cell free and cell-based assays than the first generation inhibitor teriflunomide. SINGAPORE, Oct. M edia and IR contacts.

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Pharmaceuticals Cell Based Assays Clinical Development Treatment 40

Drug Target Review

JULY 6, 2023

allowing researchers to use “certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the FDA to investigate the safety and effectiveness of a drug.” A new research paper, co-authored by PETA Science Consortium International e.V., Annals of Internal Medicine.

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Agency IQ

APRIL 12, 2024

Cell-based assays , while more complex to develop and use, offer another option for characterizing product activity at a slightly higher level, allowing sponsors to measure the further downstream effects of products (e.g., morphological cell changes or alterations in protein production or expression).

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