Related Experiment Video
Updated: Nov 6, 2025
06:31
Precision Implementation of Minimal Erythema Dose MED Testing to Assess Individual Variation in Human Inflammatory Response
Published on: October 3, 2019
8.9K
Towards a Clinical Efficacy Evaluation System Adapted for Personalized Medicine
1HK Modern Chinese Medicine R&D Center, Hong Kong.
Pharmacogenomics and Personalized Medicine
|May 6, 2021
Summary
Precision medicine (PM) and traditional Chinese medicine (TCM) share personalized approaches. The US FDA's clinical trial system can scientifically evaluate TCM efficacy, integrating it into modern medicine.
Area of Science:
- Integrative medicine
- Personalized medicine
- Traditional Chinese Medicine (TCM)
Background:
- Precision medicine (PM) is shifting healthcare towards personalized approaches based on biomarkers.
- Traditional Chinese Medicine (TCM) offers a holistic, personalized system operating at the organism level.
- Current clinical trial and efficacy evaluation (CTEE) systems often fail to recognize TCM's effectiveness.
Purpose of the Study:
- To analyze and compare personalized systems in PM and TCM.
- To demonstrate the applicability of PM's CTEE methods to TCM.
- To establish a framework for scientifically validating TCM within modern medicine.
Main Methods:
- Comparative analysis of biomarker-based personalization in PM and syndrome-based personalization in TCM.
- Logical reasoning to assess the compatibility of CTEE systems.
- Examination of the structural relationships between biomarkers/diseases in PM and syndromes/diseases in TCM.
Main Results:
- A clear structural consistency was found between PM's biomarker-disease relationships and TCM's syndrome-disease relationships.
- The US FDA's CTEE system for PM is demonstrably applicable to TCM.
- The proposed framework provides a scientific basis for evaluating TCM treatments.
Conclusions:
- The CTEE system developed for PM can be adapted to rigorously evaluate TCM efficacy.
- This adaptation can facilitate the integration of TCM into the modern medical system under scientific norms.
- Scientific validation of TCM through this system is expected to enhance its acceptance and application.
Related Concept Videos
02:50Combination Therapies and Personalized Medicine
5.4K
Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
5.4K
01:20Measurement of Bioavailability: Pharmacodynamic Methods
46
Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
46
01:24Dosage Regimen: Individualization
44
Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
44
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
47
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
47
01:13Bioequivalence studies: Biowaivers
52
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
52
01:12Analysis of Population Pharmacokinetic Data
509
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
509