Browsing Research publications by Author "Cetintas, Hacer Coskun"
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Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
Rahalkar, Hasumati; Cetintas, Hacer Coskun; Salek, Mir-Saeed Shayegan (2018-09-28)Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations ...