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Cell Based Assays

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Inside The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials–Sophisticated Bioanalytical Approaches to Support Complex Modalities

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials.

Clinical Trials

Clinical Trials Trials Pharmacokinetics Small Molecule

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Inside The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials–Sophisticated Bioanalytical Approaches to Support Complex Modalities

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

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