Light obscuration testing is the preferred method of sub-visible particle quantification but is not suitable for every preparation.
Light obscuration testing is the preferred method of sub-visible particle quantification but is not suitable for every preparation.
Light obscuration testing is the preferred method of sub-visible particle quantification but is not suitable for every preparation.
A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.