Regulatory evaluation of biosimilars throughout their product life-cycle

por Kang, Hye-Na, Knezevic, Ivana
Publicado 2018

Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements

por Hamel, Hugo, Kang, Hye-Na
Publicado 2019

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019

por Kang, Hye-Na, Thorpe, Robin, Knezevic, Ivana
Publicado 2020

Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study

por Thorpe, Robin, Grampp, Gustavo, Kang, Hye-Na, Knezevic, Ivana
Publicado 2019

WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019

por Sheets, Rebecca, Kang, Hye-Na, Meyer, Heidi, Knezevic, Ivana
Publicado 2020

Development of mRNA Vaccines: Scientific and Regulatory Issues

por Knezevic, Ivana, Liu, Margaret A., Peden, Keith, Zhou, Tiequn, Kang, Hye-Na
Publicado 2021

Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products()

por Lei, Dianliang, Schmidt, Herbert, Knezevic, Ivana, Zhou, Tiequn, Kang, Hye-na, Kopp, Sabine
Publicado 2020

Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience

por Kurki, Pekka, Kang, Hye-Na, Ekman, Niklas, Knezevic, Ivana, Weise, Martina, Wolff-Holz, Elena
Publicado 2022

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021

por Wadhwa, Meenu, Kang, Hye-Na, Thorpe, Robin, Knezevic, Ivana, Aprea, P., Bielsky, M.-C., Ekman, N., Heim, H.-K., Joung, J., Kurki, P., Lacana, E., Njue, C., Nkansah, E., Savkina, M., Thorpe, R., Yamaguchi, T., Wadhwa, M., Wang, J., Weise, M., Wolff-Holz, E.
Publicado 2022

Regulatory challenges with biosimilars: an update from 20 countries

por Kang, Hye‐Na, Thorpe, Robin, Knezevic, Ivana, Casas Levano, Mary, Chilufya, Mumbi Bernice, Chirachanakul, Parichard, Chua, Hui Ming, Dalili, Dina, Foo, Freddie, Gao, Kai, Habahbeh, Suna, Hamel, Hugo, Kim, Gi Hyun, Perez Rodriguez, Violeta, Putri, Desi Eka, Rodgers, Jacqueline, Savkina, Maria, Semeniuk, Oleh, Srivastava, Shraddha, Tavares Neto, João, Wadhwa, Meenu, Yamaguchi, Teruhide
Publicado 2020