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From Tradition to Evidence-base: Leveraging TCM Human Use Experience in Modern Drug Development

https://doi.org/10.2139/ssrn.4835230
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What this work says

Outgoing claims: the papers this work cites, builds on, or argues with.

inferredcites →https://doi.org/10.1007/s11655-019-3459-7openalex-extracted
Evidence-Based Clinical Chinese Medicine: Novel Exploration through Global Vision
inferredcites →https://doi.org/10.1007/s40264-018-0767-7openalex-extracted
Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance
inferredcites →https://doi.org/10.1007/s43441-023-00588-0openalex-extracted
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions
inferredcites →https://doi.org/10.1016/j.bcp.2017.06.123openalex-extracted
Major achievements of evidence-based traditional Chinese medicine in treating major diseases
inferredcites →https://doi.org/10.1016/j.biotechadv.2011.07.014openalex-extracted
Plant-made therapeutics: An emerging platform in South Africa
inferredcites →https://doi.org/10.1016/j.chmed.2023.09.002openalex-extracted
Clinical value-oriented research paradigm about inheritance and innovation development of TCM dominant diseases
inferredcites →https://doi.org/10.1016/j.det.2022.02.003openalex-extracted
How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin?
inferredcites →https://doi.org/10.1016/j.euf.2023.10.014openalex-extracted
Evaluating the Certainty of Evidence in Evidence-based Medicine
inferredcites →https://doi.org/10.1016/j.jep.2014.07.015openalex-extracted
The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004–2012
inferredcites →https://doi.org/10.1016/j.jep.2016.09.024openalex-extracted
Development of Ayurveda – Tradition to trend
inferredcites →https://doi.org/10.1016/j.jep.2017.06.047openalex-extracted
Herbal medicinal products – Evidence and tradition from a historical perspective
inferredcites →https://doi.org/10.1016/j.jep.2021.114587openalex-extracted
Efficacy and safety of standardized Ginkgo biloba L. leaves extract as an adjuvant therapy for sudden sensorineural hearing loss: A systematic review and meta-analysis
inferredcites →https://doi.org/10.1016/j.jhazmat.2024.134206openalex-extracted
Exposure to heavy metallic and trace essential elements and risk of diminished ovarian reserve in reproductive age women: A case-control study
inferredcites →https://doi.org/10.1016/j.jpain.2024.03.017openalex-extracted
The Mediating Role of Pain Cognitions and Pain Sensitivity in the Treatment Effect of Perioperative Pain Neuroscience Education in People Undergoing Surgery for Lumbar Radiculopathy
inferredcites →https://doi.org/10.1016/j.maturitas.2016.06.007openalex-extracted
The COMET (Core Outcome Measures in Effectiveness Trials) Initiative
inferredcites →https://doi.org/10.1016/j.phrs.2022.106314openalex-extracted
The path towards FDA approval: A challenging journey for Traditional Chinese Medicine
inferredcites →https://doi.org/10.1016/j.phrs.2022.106528openalex-extracted
Opportunities and hurdles to European market access for multi-herbal traditional Chinese medicine products: An analysis of EU regulations for combination herbal medicinal products
inferredcites →https://doi.org/10.1016/j.phymed.2018.03.048openalex-extracted
European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States
inferredcites →https://doi.org/10.1016/j.phymed.2024.155486openalex-extracted
TCMSSD: A comprehensive database focused on syndrome standardization
inferredcites →https://doi.org/10.1016/j.yrtph.2020.104647openalex-extracted
Regulatory landscape of dietary supplements and herbal medicines from a global perspective
inferredcites →https://doi.org/10.1016/s0140-6736(16)31592-6openalex-extracted
Progress in evidence-based medicine: a quarter century on
inferredcites →https://doi.org/10.1017/erm.2018.3openalex-extracted
What has traditional Chinese medicine delivered for modern medicine?
inferredcites →https://doi.org/10.1021/acs.jnatprod.9b00949openalex-extracted
Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective
inferredcites →https://doi.org/10.1038/s41598-019-56394-yopenalex-extracted
Reduction in the Incidence of Urological Cancers after the Ban on Chinese Herbal Products Containing Aristolochic Acid: An Interrupted Time-Series Analysis
inferredcites →https://doi.org/10.1053/j.ackd.2019.08.003openalex-extracted
Toxicity of Herbs, Vitamins, and Supplements
inferredcites →https://doi.org/10.1080/10408398.2018.1524364openalex-extracted
Current regulatory guidelines and resources to support research of dietary supplements in the United States
inferredcites →https://doi.org/10.1080/10408398.2022.2124230openalex-extracted
Label compliance for ingredient verification: regulations, approaches, and trends for testing botanical products marketed for “immune health” in the United States
inferredcites →https://doi.org/10.1080/14737175.2019.1596803openalex-extracted
Traditional Ayurvedic and herbal remedies for Alzheimer’s disease: from bench to bedside
inferredcites →https://doi.org/10.1080/19390211.2021.1990171openalex-extracted
Pharmacopeial Standards for the Quality Control of Botanical Dietary Supplements in the United States
inferredcites →https://doi.org/10.1097/00045391-200405000-00010openalex-extracted
Regulatory Toxicology Perspectives on the Development of Botanical Drug Products in the United States
inferredcites →https://doi.org/10.1111/1475-6773.13697openalex-extracted
Birds of a feather flock together: Comparing controlled pre–post designs
inferredcites →https://doi.org/10.1111/all.15887openalex-extracted
Next generation health guidelines: The role of real‐life data in evidence‐based medicine
inferredcites →https://doi.org/10.1111/cts.12987openalex-extracted
Evolving drug regulatory landscape in China: A clinical pharmacology perspective
inferredcites →https://doi.org/10.1111/jebm.12389openalex-extracted
Evidence‐based traditional Chinese medicine research: Beijing Declaration
inferredcites →https://doi.org/10.1111/jebm.12420openalex-extracted
Evidence‐based traditional Chinese medicine research: Two decades of development, its impact, and breakthrough
inferredcites →https://doi.org/10.1142/s0192415x21500622openalex-extracted
The Impact of Artificial Intelligence on Traditional Chinese Medicine
inferredcites →https://doi.org/10.1155/2015/425037openalex-extracted
Developing Traditional Chinese Medicine in the Era of Evidence-Based Medicine: Current Evidences and Challenges
inferredcites →https://doi.org/10.1177/15347354211020105openalex-extracted
Patient Reported Traditional Chinese Medicine Spleen Deficiency Syndrome (TCM-SDS) Scale for Colorectal Cancer: Development and Validation in China
inferredcites →https://doi.org/10.1177/20420986221125006openalex-extracted
Pharmacovigilance: reporting requirements throughout a product’s lifecycle
inferredcites →https://doi.org/10.1186/s12877-023-03840-2openalex-extracted
Effects of 12-week Tai Chi program on physical function, depression, and quality of life among cognitively impaired older adults: a feasibility study
inferredcites →https://doi.org/10.1186/s12961-023-01095-2openalex-extracted
Learning health systems and evidence ecosystems: a perspective on the future of evidence-based medicine and evidence-based guideline development
inferredcites →https://doi.org/10.1186/s13002-023-00605-4openalex-extracted
The medicinal plant used in the Guangxi Fangcheng Golden Camellias national nature reserve, a coastal region in southern China
inferredcites →https://doi.org/10.1515/reveh-2021-0009openalex-extracted
Understanding Holism in the light of principle underlying practice of Unani Medicine
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.2017.0073openalex-extracted
[Consideration about chemistry, manufacture and control (CMC) key problems in simplified registration of classical traditional Chinese medicine excellent prescriptions].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20170913.002openalex-extracted
[Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20190630.305openalex-extracted
[Opportunities and challenges in development of compound preparations of traditional Chinese medicine: problems and countermeasures in research of ancient classical prescriptions].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20201230.301openalex-extracted
[Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20210122.501openalex-extracted
[Data collection, quality and evidence formation for human use experience of traditional Chinese medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20210213.501openalex-extracted
[Theoretical thinking on guiding research and development of new drugs of traditional Chinese medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20210219.501openalex-extracted
[Expert consensus on key issues of quality control in clinical trials of new drugs of traditional Chinese medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20210517.501openalex-extracted
[Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20220105.501openalex-extracted
[Exploration and reflection on evaluation methodology of human use experience for new Chinese drug development].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20220124.601openalex-extracted
[Types of clinical data and statistical methodology of human use experience in traditional Chinese medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.202204012.601openalex-extracted
[Evaluation for druggability of traditional Chinese medicine preparations in medical institutions based on human use experience].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20220601.501openalex-extracted
[Expert consensus on human use experience research of traditional Chinese medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20221126.501openalex-extracted
[Technical points of human use experience of ethnic medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20230601.501openalex-extracted
[Quality requirements of human use experience research on traditional Chinese medicine].
inferredcites →https://doi.org/10.19540/j.cnki.cjcmm.20231113.302openalex-extracted
[Pharmaceutical changes and countermeasures for transformation of traditional Chinese medicine preparations in medical institutions into new drugs based on human use experience].
inferredcites →https://doi.org/10.2196/29290openalex-extracted
A Traditional Chinese Medicine Syndrome Classification Model Based on Cross-Feature Generation by Convolution Neural Network: Model Development and Validation
inferredcites →https://doi.org/10.3233/cbm-170805openalex-extracted
Comparative analysis of immune function, hemorheological alterations and prognosis in colorectal cancer patients with different traditional Chinese medicine syndromes
inferredcites →https://doi.org/10.3389/fchem.2022.964744openalex-extracted
Rapid quantification of bioactive compounds in Salvia miltiorrhiza Bunge derived decoction pieces, dripping pill, injection, and tablets by polarity-switching UPLC-MS/MS
inferredcites →https://doi.org/10.3389/fmed.2021.669509openalex-extracted
Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model
inferredcites →https://doi.org/10.3389/fphar.2017.00381openalex-extracted
Innovating Chinese Herbal Medicine: From Traditional Health Practice to Scientific Drug Discovery
inferredcites →https://doi.org/10.3389/fphar.2023.1195364openalex-extracted
Perspectives of international multi-center clinical trials on traditional Chinese herbal medicine
inferredcites →https://doi.org/10.3389/fphar.2024.1319551openalex-extracted
Effectiveness and safety of Danshen injections in treatment of cardiac failure: a network meta-analysis
inferredcites →https://doi.org/10.5582/ddt.2022.01115openalex-extracted
Recent advances in Chinese patent medicines entering the international market
inferredcites →https://doi.org/10.5740/jaoacint.18-0379openalex-extracted
Regulatory Aspects of Traditional Indian Medicines (TIM) in India and in International Purview

What points at this work

Incoming claims: where this work appears in other papers’ reference lists and arguments.

inferred← citeshttps://doi.org/10.1007/s11596-025-00103-6openalex-snapshot
Artificial Intelligence in Traditional Chinese Medicine: Multimodal Fusion and Machine Learning for Enhanced Diagnosis and Treatment Efficacy
inferred← citeshttps://doi.org/10.21203/rs.3.rs-9777907/v1openalex-snapshot
Plant-Based Bioactive Phytonutrients: From Chemical Diversity to Mechanistic Actions and Human Health: A Systematic Review
Editorial review for independent work. ICSAC — the Institute for Complexity Science and Advanced Computing — runs a structured editorial panel for researchers publishing outside journals, and publishes on CiteStamp rails. Submission is free and goes through ORCID: icsacinstitute.org/submit.