Remove Dosage Remove Packaging Remove Presentation
article thumbnail

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. mins and 5.0

article thumbnail

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com Performing calculations for the formulation of pharmaceutical dosage forms and related preparations is a key activity in compounding. Active moiety calculations determine the drug amount needed to prepare the dosage form quantity. Policy-exception salts.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

More than 30,000 patients have been treated with CAR T cell therapies, with studies including an analysis of BMS presented recently showing that most serious adverse events occur within the first two weeks of infusion. Sign up for our daily news round-up! Give your business an edge with our leading industry insights.

article thumbnail

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
article thumbnail

PODD 2025 Unveils Agenda Highlighting Innovation in Drug Delivery Technologies

PharmTech

Mateja Kramer, PhD , global head of innovation at Novartis, and Nicholas Schill, PhD , senior director of landscaping & platform definition at AbbVie, will present as part of the conference’s Pharma Company Spotlights.

article thumbnail

LEO Pharma Takes Over Global Development of Spevigo for Rare Skin Disease GPP

PharmTech

Study Protocol of the Global Effisayil 1 Phase II, Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Spesolimab in Patients with Generalized Pustular Psoriasis Presenting with an Acute Flare. 2021 11:e043666. Bachelez, H.; Marrakchi, S.; Trial of Spesolimab for Generalized Pustular Psoriasis. N Engl J Med. 2021 385:2431–2440.

article thumbnail

Pack Expo Las Vegas Marks 30th Anniversary with New Experiences for 2025

PharmTech

Image Credit: © wacomka - stock.adobe.com PMMI, The Association for Packaging and Processing Technologies, has announced some of the unique features being made available to attendees at Pack Expo Las Vegas, to be held from Sept. Pharmaceutical manufacture background with glass bottles with clear liquid on automatic conveyor line.