|
KMID : 1142220060010020015
|
|
Regulatory Research on Food, Drug & Cosmetic
2006 Volume.1 No. 2 p.15 ~ p.23
|
|
|
Points to Consider in the Evaluation of Biopharmaceuticals: Review of Quality Control
|
|
Sohn Yeo-Won
|
|
|
Abstract
|
|
|
|
Progress in biotechnology is bringing about the development of various types of new medicines to cure diseases. Considering the huge potential of biotechnological products and their impact on the medical market, it is certain that the biotechnology-based medicine will lead the bioindustry in this century. In Korea, active governmental support and vigorous research efforts in this area have produced new categories of biotechnological medicines such as recombinant DNA products, monoclonal antibodies, cell and gene therapy products, and biochips. Nevertheless, to enhance the market value of biotechnological products, their quality, safety and efficacy should be guaranteed. This paper explains the procedure of development and approval of biotechnological products and the points to consider in the evaluation of biotechnological medicines. Also, it discusses the important aspects in evaluating biotechnologicals such as gene therapy products, cell therapy products, and biochips.
|
|
|
KEYWORD
|
|
|
biotechnological products, recombinant DNA products, gene & cell therapy products, biochip, quality
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|