REGULATORY CONSIDERATIONS FOR BIOSIMILARS

Regulatory considerations for biosimilars

Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry.While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, si

read more


Practice, Constraint, and Mathematical Concepts

In this piece I articulate and defend a conception of mathematical practice and mathematical subject-matter, which is responsive both to a sensible pluralism concerning the connection between inferential practices and guiding interests, on the one hand, and to the objective content-determining structure of mathematical concepts on the other.I begin

read more

High-Resolution Splenic Imaging: [68Ga]Ga-Oxine Red Blood Cell PET/CT for Differentiation of Splenosis Mimicking Malignant Lymphoma

The differentiation of splenic read more tissue from malignant lesions via imaging may be challenging, particularly considering aberrant or accessory lesions and diseases that are rarely encountered.Functioning splenic tissue can be identified using technetium-99m red blood cell (99mTc-RBC) scintigraphy, but its sensitivity is limited and may not b

read more