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Episode 573: Ceiling dose of ketorolac for renal colic in the ED

Pharmacy Joe

In 1989, a study in the Journal of Clinical Pharmacology compared 10, 30, and 90 mg of IM ketorolac with placebo in 126 patients with cancer pain. While all doses were more effective than placebo, there was no difference in effectiveness between 10, 30, or 90 mg of IM ketorolac.

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NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

Putting Patients First Blog

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Clinical Pharmacology & Therapeutics , 97(3) , 263–273.

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

FDA Law Blog: Biosimilars

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. Stay tuned for the next iteration of the Cliffs Notes to the Cliffs Notes.