Technical guidelines for non-clinical pharmacological research of traditional Chinese medicine (TCM) formulae.

Non-clinical pharmacology of traditional Chinese medicine (TCM) formulae plays a crucial role in elucidating their therapeutic mechanisms. With the integration of cutting-edge disciplines such as systems biology, big data, and artificial intelligence, the research depth and breadth in this field continue to expand. However, technical standards for non-clinical pharmacology research on TCM formulae have not yet been established. To address this, technical guidelines for non-clinical pharmacology research of TCM formulae were formed, aiming to scientifically standardize research content, elevate research quality, and facilitate the mutual translation between clinical and basic research. Guided by integrative pharmacology of TCM and driven by clinical value, these guidelines employ multi-dimensional qualitative pharmacokinetics (PK) and pharmacodynamics (PD) studies alongside quantitative "PK-PD" studies of key components. This approach enables the transition from panoramic description to precise mechanistic research, establishing a complete evidence chain system for the effectiveness of TCM formulae and demonstrating their holistic action characteristics of "multi-component, multi-pathway, multi-target". Meanwhile, the guidelines emphasize that animal models for TCM research should ensure stability and reproducibility. Additionally, pharmacodynamic evaluation is characterized by its measurability and quantifiability. The mechanisms of action at the molecular level should be in-depth and interpretable. These aspects collectively provide guidance for basic non-clinical pharmacology research on TCM formulae and the development of new TCM drugs. The formulation of these guidelines leveraged the research strengths of the drafting units' teams, incorporated literature review findings, and achieved consensus through extensive discussions among multidisciplinary experts. Broad expert opinions from universities, research institutes, and enterprises engaged in new drug development were solicited, ensuring the guidelines' practicality, standardization, scientific rigor, and feasibility.