Concepedia

Pragmatic rules for comparability of biological medicinal products

R. Martijn van der Plas, Marcel H. N. Hoefnagel, Hans L. Hillege, Kit C. B. Roes

Biologicals · 2019 · 14 citations · 4 references

DOIFull text

Open access

Concepts

References

4

Characterizing biological products and assessing comparability following manufacturing changes

Arthur J. Chirino, Anthony R. Mire‐Sluis · Nature Biotechnology · 2004 · 364 citations

, , +14

Development of statistical methods for analytical similarity assessment

Yi Tsong, Xiaoyu Dong, Meiyu Shen · Journal of Biopharmaceutical Statistics · 2016 · 61 citations

, , +17

On Assessment of Analytical Similarity in Biosimilar Studies

Drug Designing Open Access · 2014 · 29 citations

, , +17

Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

Richard K. Burdick, Neal Thomas, Aili Cheng · Statistics in Biopharmaceutical Research · 2017 · 15 citations · Full text

, , +13