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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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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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How long does Zofran take to work?

The Checkup by Singlecare

When over-the-counter (OTC) remedies don’t cut it, your healthcare provider may prescribe Zofran ( ondansetron ), a medication used to treat upset stomach and prevent vomiting—especially when caused by chemotherapy, radiation therapy, and surgery. The dosage form impacts how long Zofran takes to kick in.

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Cymbalta generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. Cymbalta may have several off-label uses in addition to its FDA-approved uses. It is also approved for fibromyalgia and chronic muscle pain. Approved by the U.S.

Dosage 52
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Mirtazapine for dogs: Dosage and safety

The Checkup by Singlecare

Veterinarians may use it in a cat to prevent nausea and vomiting due to chemotherapy. Mirtazapine manufactured for humans has fixed dosage strengths of 7.5 Veterinarians typically rely on other appetite stimulants because they know more about effective dosages. Its use as an antiemetic in dogs hasn’t been studied.

Dosage 52
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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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FDA grants orphan drug designation for Syros’ pancreatic cancer treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for Syros Pharmaceuticals’ SY-5609 for the treatment of pancreatic cancer. . An oral inhibitor of cyclin-dependent kinase 7 (CDK7), SY-5609 is presently being analysed alongside chemotherapy as a treatment for relapsed metastatic pancreatic cancer patients.

FDA 52
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Can you take fluconazole for yeast infections?

The Checkup by Singlecare

Fluconazole is approved by the Food and Drug Administration (FDA) to treat vulvovaginal candidiasis (vaginal yeast infections), oral and esophageal candidiasis, systemic candidiasis, urinary tract infections, and peritonitis. If you are wondering if you can use fluconazole for a yeast infection, the answer is yes.

Dosage 85