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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

Dosage 115
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ACMT Toxicology Visual Pearl: Who Doesn’t Like a Nice Rosé?

ALiEM - Pharm Pearls

[1,2] Severe symptoms such as hypovolemia, shock, metabolic acidosis Persistent and severe GI symptoms Lethargy or toxic appearance Serum iron level greater than 500 mcg/dL What is the dosage of deferoxamine for iron toxicity? [1] Clinical pharmacology, therapeutic use and potential of COMT inhibitors in Parkinson’s disease.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

When information specific to the reference product is described in the biosimilar or interchangeable biosimilar product’s labeling (for example, data from clinical trials of the reference product in the ADVERSE REACTIONS and CLINICAL STUDIES sections), the reference product’s proper name should be used.

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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. Either FDA approval of a lower dosage size or an automatic substitution policy would likely be required to get IV ketorolac doses down to 10 mg routinely.

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Recommended Medical Reference

RX Note

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)