About Author: DEDAKIYA ARJUN S.*, BANDHIYA HEMANT M., VIPUL P. PATEL, TUSHAR R. DESAI2
1. Assistant professor, Department of pharmaceutics, R. K. College of Pharmacy, Kasturbadham,Rajkot.
2. Principal, Department of pharmacology, R. K. College of Pharmacy, Kasturbadham,Rajkot.
3. Research Scholar, R. K. College of Pharmacy, Kasturbadham, Rajkot
Reference ID: PHARMATUTOR-ART-1061
Abstract
This article provides a basic view of what defines biological medicinal Products, often called biologicals, and how they differ from chemical products. In entering into this thought process, let us remember that proteins range in size from small amino acid chains up to macromolecules of hundreds of kilodaltons in size. In addition, in order to appreciate the science behind the regulations, an understanding of organic chemistry is necessary, and preferably knowledge of molecular cell biology and how proteins are created in cells via the DNA expression mechanisms. Although the details are inevitably complex and specialist as a result, we will look at some basic concepts pertinent to biologicals so that a regulatory generalist can be effective in dealing with such products.