News
Elemental Impurities in Purified Water
In line with the Ph. Eur. implementation strategy for the ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) has been deleted and a new section is included: “If purified water (...) Read more
Bioequivalence of Topical Generic Products
On September 2018, FDA revised the status of Topical Generic Products and their future perspectives in a two-day Conference on Complex Generic Drug Product Development Workshop. One year before, on October 2017, FDA held (...) Read more
Heparin Anti-factor Activity Testing
Heparin is a sulfated glycosaminoglycan present as a mixture of heterogeneous molecules varying in molecular weighs used in medicine as anticoagulant. It is present in mammalian tissues and is usually obtained from the intestinal mucosa or other (...) Read more
New FDA Guidance on Bioanalytical Method Validation
The FDA has issued a Guidance for Industry entitled “Bioanalytical Method Validation”. This guidance replaces the draft guidance that was issued in September 2013, and reflects advances in science and technology validating bioanalytical methods. Bioanalytical (...) Read more
