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Yang S, Kampp J

Some capsular fibrosis and periportal fibrosis may be present

Detecting and avoiding likely false-positive findings a practical guide

With the development of SC injection devices, the paradigm of drug product development has continued to shift towards patient centricity by enabling self-administration and ease of use for patients, improving compliance and adherence and reducing the burden on healthcare systems.1 The number of approved monoclonal antibody (mAb) products has been increasing over the last few decades, with a proportional increase in the number of SC products (Figure 1), based on the information compiled by ten23 health on US FDA-approved products

This method accounts for approximately 38.6% of the market in 2025 and is preferred by generic manufacturers for its lower capital requirements, shorter lead times, and well-defined impurity profiles that facilitate regulatory comparability studies