Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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.…