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

The aim of this paper is to present a theoretical model for efficiency evaluation of a simple cycloid drive train with one degree of freedom (DOF) or constrained cycloid drive.In order to evaluate the efficiency, it is necessary to find SectionalComponent the losses generated in the simple cycloid drive, where only losses depending on the load were

Hereditary motor and sensory neuropathy Bike Parts - Lubes (HMSN), also known as Charcot-Marie-Tooth disease (CMT), is a member of the inherited neuropathy family with specific clinical and genetical manifestations.More than twenty genes have been linked to HMSN, and the number might increase.Regarding diagnosis, a healthcare provider should be sus

Traditional spinning and weaving have been formed following the climatic, material, and spiritual needs of different relatives.Generally, the natural resources of each region are selected as the first option for the production of hand-woven textiles.This research introduces a valuable plant resource called "Malleh cotton", which has been revived an

Biomedical applications of titanium and its alloys are possible due to their suitable characteristics for bone replacement, including good mechanical properties, excellent corrosion resistance and high biocompatibility.However, one of their main limitations is the fibrous tissue capsule that IRON CHELATE 25 MG is formed around the material, which c