Clinical Pharmacology, FDA and Protein Expression

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Clinical Pharmacology

FDA

Protein Expression

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured.

Therapies

Therapies FDA Production Disease

FDA’s Project Optimus: A new era in oncology drug dosing

Drug Target Review

JANUARY 20, 2025

Molecular factors Molecular markers, such as protein expression and signalling pathway activation, also guide therapy choices. For example, PD-L1 expression predicts the response to immune checkpoint inhibitors. Journal of Clinical Oncology, 33 (9), 975977. Adaptive Clinical Trial Design in Oncology: An Overview.

Clinical Trials

Clinical Trials Trials Drugs Drug Development

Drug Discovery Digest

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA’s Project Optimus: A new era in oncology drug dosing

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