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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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FDA Approves Generic Drug to Treat Allergic Dermatitis in Cats

Drug Topics

Sponsored by Provetica, Modulis for Cats contains the same active ingredient, concentration and dosage form as the Atopica for Cats brand product.

Dosage 247
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Gabapentin dose for cats: Standard and maximum dosages

The Checkup by Singlecare

Food and Drug Administration (FDA) as an anticonvulsant medication for humans and is also commonly used in pets. As Dr. Spragley mentioned, the standard gabapentin dosage for cats is 50 mg. However, the dosage can vary with each cat. Gabapentin is approved by the U.S. Cats may experience anxiety from stressful events.

Dosage 97
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FDA Approves Aprocitentan for Treatment of Hypertension in Combination With Other Drugs

Pharmacy Times

The FDA has only approved aprocitentan (Tryvio; Idorsia) in the 12.5 mg dosage as the effects were similar between the 25 mg and 12.5 mg dosages.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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Edible sensor delivers real-time antiretroviral dosage data

European Pharmaceutical Review

An innovative ingestible sensor technology tested in an interventional clinical trial provided HIV patients with real-time antiretroviral dosage data , enabling them to better control their infection. The study is one of earliest that uses an FDA-approved ingestible sensor system for ARV therapy in HIV-infected adults.

Dosage 112
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Protega scores FDA nod for new dosage of abuse-deterrent opioid Roxybond

Fierce Pharma

The FDA has approved the first abuse-deterrent, immediate-release, 10 mg opioid tablet for pain management. The drug, Roxybond, has been approved in other dosages.

Dosage 73