Omics and its potential impact on R&D and regulation of complex herbal products
Datos Bibliográficos
| ID | 14735665 |
|---|---|
| Autores | Olavi Pelkonen (University of Oulu, autor de correspondencia), Markku Pasanen (0000-0002-2557-9034, University of Eastern Finland), John C Lindon (0000-0002-0916-6360, Imperial College London), Kelvin Chan (0000-0002-5738-9630, The University of Sydney), Liping Zhao (0000-0002-7682-9339, Shanghai Jiao Tong University), Greer Deal (Centre for Innovation in Regulatory Science), Qihe Xu (0000-0002-8015-2674, King's College London), Tai-Ping Fan, Tai‐Ping Fan (0000-0003-1000-5369, University of Cambridge) |
| Año | 2012 |
| Volumen | 140 |
| Número | 3 |
| Páginas | 587-593 |
| Fecha de publicación | 2012-04-01 |
| Peer Reviewed | Sí |
| Open Access | Sí |
| Tipo | ARTICLE |
| Revista | Journal of Ethnopharmacology (JOURNAL) |
| Identificadores de la revista | ISSN: 0378-8741 • E-ISSN: 1872-7573 |
| Editorial | Elsevier BV (PUBLISHER) |
| DOI | 10.1016/j.jep.2012.01.035 |
| PMID | 22313626 |
| OpenAlex | W2011774830 |
| Idioma | EN |
| Citas recibidas | 4 |
| Referencias citadas | 59 |
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),(1) 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
Alternative medicine · Bioinformatics · Biology · Computational biology · Integrative medicine · Omics · Pathology · Regulatory agency · Regulatory science · Scrutiny · Systems biology · Computational Drug Discovery Methods · Medicine · Metabolomics and Mass Spectrometry Studies · Traditional Chinese Medicine Analysis · Pharmacology
| Obras citantes distintas | 4 |
|---|---|
| Citas por año | 0,29 |
| Intervalo de citas | 2012 - 2018 (7) |
| Velocidad de citación | historical |
| Altamente citado | No |
| Tipos de cita | Neutras: 4 |