QUALITY, NON-CLINICAL AND CLINICAL CONSIDERATIONS FOR BIOSIMILAR MONOCLONAL ANTIBODY DEVELOPMENT: EU, WHO, USA, CANADA, AND BRICS-TM REGULATORY GUIDELINES

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 to identify challenges.Materials and Methods: The current valid guidelines of EMA, WHO, USFDA, BGTD/HC, ICH, and BRICS-TM were

Free-living animals rely on cognitive functions, such as learning and memory, for numerous aspects of their survival.However, research involving these mechanisms is often limited to the laboratory where animals are far removed from natural influences.Here, we adapted the Morris Water Maze (MWM) for use in the field to test learning and memory of fr

This research aims to integrate the severity of energy poverty with a multidimensional indicator established using the GRA-SRA methodology.In this case study, N11 nations utilize data from 2001 to 2017 to create a multidimensional indicator of energy poverty by integrating 13 indicators for N11 nations (energy availability, energy cleanliness, and

We describe and delimit with integrative taxonomy the new springtail species Desoria calderonis sp.nov.(Collembola: Isotomidae).This cryophilic species is strictly linked to the supraglacial stony debris of the isolated Calderone glacier (Central Apennines, Italy), one of the southernmost glaciers of Europe.Desoria calderonis sp.nov.could belong to

Nephrocutaneous fistula (NCF) is a rare and severe complication of renal disease and surgical procedures.Treatments for NCF are based on the renal function, and can include nephrectomy, heminephrectomy, nephroureterectomy, endourological maneuvers or antibiotic therapy alone.Here we report a Decorative Trays case of a chronic NCF which occurred 5 y