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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)



Advancements and knowledge gaps in ICH Q2(R2)

15 May 2024 | By , , , , , ,

In this article, Amanda Guiraldelli Mahr, Joachim Ermer, Jaime Marach, Phil Borman and other members of USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors also identify areas that would benefit from additional guidance and compare…


How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery

26 June 2020 | By ,

Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…