Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities. Good manufacturing practice (GMP) ...
When it comes to dissolution testing, research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality. Studying how a drug ...
The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...
The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs. The British ...
What is dissolution testing and why is important in drug development, formulation and testing? For this Teach Me in 10 episode, we're joined by Lorraine Kay from Agilent Technologies who gives us a ...
Teva is voluntarily recalling a single lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure that was detected during a routine stability test. Teva is voluntarily recalling a single lot ...
The dissolution profile of inhaled drugs underpins therapeutic efficacy and is an area of increasing regulatory scrutiny, particularly for the demonstration of bioequivalence in a generic. The new ...
In the manufacture of solid dosage forms, the rate at which the active pharmaceutical ingredient (API) is dissolved into solvents simulating the digestive tract fluids is determined with dissolution ...
The Pharmaceutical Dissolution Testing Services Market is poised for significant growth, with a projected market value of US$1.53 billion by 2033. This surge represents a substantial increase from the ...
that would penetrate the first stage of the impactor), the ex-throat dose or the Fine Particle Dose (FPD); the fraction of the dose defined as respirable on the basis of size. The dose is collected on ...