TY - JOUR
T1 - Omics and its potential impact on R&D and regulation of complex herbal products
AU - Pelkonen, Olavi
AU - Pasanen, Markku
AU - Lindon, John C.
AU - Chan, Kelvin
AU - Zhao, Liping
AU - Deal, Greer
AU - Xu, Qihe
AU - Fan, Tai Ping
N1 - Funding Information: Olavi Pelkonen (OP) is currently a co-opted expert in toxicology of EMA/HMPC (however, all the views and perspectives expressed in this article are completely of his own). OP's original research on diets and herbals has been supported by the Academy of Finland .
PY - 2012/4/10
Y1 - 2012/4/10
N2 - In traditional Chinese medicine (TCM), multicomponent and principally plant-derived drugs are used for disease prevention, symptom amelioration and treatment in a personalized manner. Because of their complex composition and consequent multiple targets and treatment objectives, the application of omics techniques and other integrative approaches seems inherently appropriate and even necessary for the demonstration of their potential preclinical and clinical safety and efficacy. This perspectives article provides proposals for the application of omics methods to the investigation of complex herbal products (CHP), including Chinese herbal medicines (CHM), both in vitro and in vivo, for preclinical and clinical toxicity, pharmacokinetics, pharmacodynamics and efficacy tests. Ultimately, such approaches could aid regulatory scrutiny and potential acceptance, although currently there is no regulatory requirement of omics-based data in any submitted dossier to any regulatory agency, including for conventional drugs and CHP. However, it has been acknowledged that such studies are being increasingly performed, and almost surely will eventually be included into regulatory submission dossiers, possibly initially as supplementary materials. Specifically for CHM and CHP, omics can play a role both in determining product composition and its variability and in monitoring biological effects in carefully selected platforms. Predicting the future is difficult, but it seems possible that regulatory acceptance of omics techniques and a systems biology approach for the study of TCM, CHM and CHP will not be long delayed. It is expected that current studies and plans employing omics techniques and other integrative approaches will prove to be positive and informative.
AB - In traditional Chinese medicine (TCM), multicomponent and principally plant-derived drugs are used for disease prevention, symptom amelioration and treatment in a personalized manner. Because of their complex composition and consequent multiple targets and treatment objectives, the application of omics techniques and other integrative approaches seems inherently appropriate and even necessary for the demonstration of their potential preclinical and clinical safety and efficacy. This perspectives article provides proposals for the application of omics methods to the investigation of complex herbal products (CHP), including Chinese herbal medicines (CHM), both in vitro and in vivo, for preclinical and clinical toxicity, pharmacokinetics, pharmacodynamics and efficacy tests. Ultimately, such approaches could aid regulatory scrutiny and potential acceptance, although currently there is no regulatory requirement of omics-based data in any submitted dossier to any regulatory agency, including for conventional drugs and CHP. However, it has been acknowledged that such studies are being increasingly performed, and almost surely will eventually be included into regulatory submission dossiers, possibly initially as supplementary materials. Specifically for CHM and CHP, omics can play a role both in determining product composition and its variability and in monitoring biological effects in carefully selected platforms. Predicting the future is difficult, but it seems possible that regulatory acceptance of omics techniques and a systems biology approach for the study of TCM, CHM and CHP will not be long delayed. It is expected that current studies and plans employing omics techniques and other integrative approaches will prove to be positive and informative.
KW - Chinese herbal medicine
KW - Future perspectives
KW - Omics in drug development
KW - Regulation of pharmaceuticals
KW - Systems biology
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U2 - 10.1016/j.jep.2012.01.035
DO - 10.1016/j.jep.2012.01.035
M3 - Article
C2 - 22313626
SN - 0378-8741
VL - 140
SP - 587
EP - 593
JO - Journal of Ethnopharmacology
JF - Journal of Ethnopharmacology
IS - 3
ER -