Perspectives on the Regulation of Biodrug Development
INTRODUCTION Biotechnologies such as recombinant DNA technology, gene transfer, cell manipulation, and cell culture have developed rapidly during the past 20 years. Using these modern techniques, a wide variety of new medically useful biotechnological/biological products (biodrugs) have been produced in adequate quantities for preclinical and clinical studies or product marketing. These products include therapeutic peptides and proteins derived from various cell substrates, gene therapy products, cell/tissue-based products, and therapeutic products derived from transgenic (Tg) animals and plants. Moreover, various nucleic acid-based drugs with a background in genomic medicine have been developed. The rapid and radical developments in the area of biodrugs are still in progress.