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ICH Q6B for Analytics

PharmTech

A detailed and thorough characterization is required to be presented to regulatory authorities as part of any submission for regulatory approval and marketing authorization. The disulfide bridges in a protein are required to be identified to confirm that first they are present and secondly that they are correctly formed.

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B. Mole calculations.

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FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

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Lorundrostat Shows Clinically Meaningful Outcomes in Patients With CKD and Hypertension

Pharmacy Times

Because these conditions are linked—sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening blood pressure control—the risk of cardiovascular disease and mortality rises significantly when CKD is present in patients with hypertension.

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FDA Posts Slate of Seven Warning Letters Following Company Inspections

PharmTech

. | Image Credit: © Tada Images - stock.adobe.com In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back to 2020 (1). American Behavioral Research Institute Boca Raton, Fla. –

FDA
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9 Sneaky Thyroid Toxins Hiding in Your Home

The Thyroid Pharmacist

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), These reactions are often due to the toxic backlog that is present in their body, which can cause them to react to everything in their environment as well. From indoor pollutants like formaldehyde (yes, really!),

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Tisento’s MELAS treatment receives fast track status from FDA

Pharmaceutical Technology

Subjects who conclude the trial will be qualified for an open-label extension trial. With no approved treatments available, present management strategies focus on symptomatic treatments and lifestyle modifications, which fall short of addressing the disease’s profound and persistent effects.

FDA