Pharmacometrics： a quantitative tool of pharmacological research  

作　　者：Qing-shan ZHENG Lu-jin LI 

机构地区：[1]Center for Drug Clinical Research,Shanghai University of Chinese Medicine,Shanghai 201203,China

出　　处：《Acta Pharmacologica Sinica》2012年第11期1337-1338,共2页中国药理学报（英文版）

摘　　要：Pharmacometrics is an interdisciplinary science with tre- mendous potential to influence decision making through the construction of mathematical and statistical models combined with graphical methods that define, challenge, and resolve queries surrounding the biological processes of a drug. In 2004, FDA published the white paper the Challenge and Oppor- tunity on the Critical Path to New Products, which advocates the model-based drug development （MBDD）. Since then, phar- macometric analysis has become an increasingly important component of New Drug Application （NDA） and Biological License Application （BLA） submitted to FDA for drug approval, labeling and trial design decisions. The academic clinical researchers are likewise confronted with the need to use data from various sources （experimental biology, preclinical models of disease, etc） in order to organize translational clinical studies in a therapeutic area. The administrators are faced with bringing together a variety of data （preclinical and clinical data, literatures, and other regulatory submissions of similar therapies） in order to make regulatory decisions. A great deal has been published in the literatures on quantitative research, especially in the field of clinical pharmacology. Therefore, wherever in industry, academia, or regulatory agencies, pharmacometrics is at the center of the translational medicine paradigm. It is difficult to imagine a more efficient, powerful, and informative drug development and evaluation process without comprehensive pharmacometric studies.Pharmacometrics is an interdisciplinary science with tre- mendous potential to influence decision making through the construction of mathematical and statistical models combined with graphical methods that define, challenge, and resolve queries surrounding the biological processes of a drug. In 2004, FDA published the white paper the Challenge and Oppor- tunity on the Critical Path to New Products, which advocates the model-based drug development （MBDD）. Since then, phar- macometric analysis has become an increasingly important component of New Drug Application （NDA） and Biological License Application （BLA） submitted to FDA for drug approval, labeling and trial design decisions. The academic clinical researchers are likewise confronted with the need to use data from various sources （experimental biology, preclinical models of disease, etc） in order to organize translational clinical studies in a therapeutic area. The administrators are faced with bringing together a variety of data （preclinical and clinical data, literatures, and other regulatory submissions of similar therapies） in order to make regulatory decisions. A great deal has been published in the literatures on quantitative research, especially in the field of clinical pharmacology. Therefore, wherever in industry, academia, or regulatory agencies, pharmacometrics is at the center of the translational medicine paradigm. It is difficult to imagine a more efficient, powerful, and informative drug development and evaluation process without comprehensive pharmacometric studies.

分 类 号：Q81[生物学—生物工程] TQ46[化学工程—制药化工]