Author

My name is Kyungmin In, and I am the head of the Research Unit at GCCL (https://eng.gccl.co.kr/). I have worked as a bioanalytical team leader for many years at several companies, where I have led method development, validation, and regulated bioanalysis for both clinical trials and nonclinical studies. My academic background includes a Ph.D. in molecular biology, with additional studies in immunology. During my Ph.D. in Germany, I focused on researching rare genetic diseases.

I have direct experience in the development and analytical validation of biosimilar products, including comparability studies, ADA (anti-drug antibody) assays, and bioequivalence assessments, which are relevant to this book’s focus on equivalence testing.

I am particularly interested in automation and reproducible data generation and analysis for bioanalysis, which has led me to explore tools like R for statistical analysis and reporting. Additionally, I have experience using commercial systems like Watson LIMS (Thermo Fisher Scientific) for efficient data management and analysis in compliance with regulatory standards.