In alignment with ICH Q3C guidelines and with reference to the  implementation requirements of major international pharmacopoeias,  a risk assessment was performed based on the evaluation of raw materials, excipients, and production processes to investigate potential residual solvents in pharmaceutical products. This study explores a harmonization strategy for harmonizing the control of residual solvents in chemical drugs under the Chinese Pharmacopoeia (Volume Ⅱ) with ICH Q3C guidelines. The proposed approach aims to serve as a reference for the systematic harmonization of ICH Q3C within the monographs of ChP Volume Ⅱ and to provide technical guidance for regulatory authorities in advising manufacturers on conducting risk assessments for residual solvents.

Both ICH Q2 guidelines and the general chapter 〈9101〉 of the 2025 Chinese Pharmacopoeia are of significant value for analytical procedure development and validation. By comparing and interpreting these regulatory guidelines, and through practical validation examples, this paper explores Analytical Quality by Design (AQbD)-based analytical procedure validation strategies. This study aims to provide reference and insights for pharmaceutical analysis and drug quality control practices.

Source data management constitutes the cornerstone of clinical trial quality. By integrating electronic source data technology with Electronic Data Capture (EDC) systems, this study pioneers the incorporation of artificial intelligence (AI) into clinical trial data management and has developed a novel clinical trial management system aimed at enhancing trial efficiency and quality. The system incorporates intelligent data entry, automated quality control, remote monitoring capabilities, and automated subject screening and recruitment functions. A pilot application within a nasopharyngeal carcinoma study demonstrated significant improvements: markedly reduced data processing time, high data accuracy, decreased frequency of on-site monitoring visits, and accelerated patient matching. These findings underscore the key contribution of AI technology to clinical trial quality control and highlight its substantial potential for further refinement and practical implementation.

Objective： To provide suggestions for optimizing the marketing registration pathway for over-the-counter traditional Chinese medicines (OTC TCMs) in China. Methods： A comparative analysis was conducted on the simplified registration system for traditional herbal medicines in the European Union, OTC Kampo preparations in Japan, and TCM marketing in China. The comparison focused on review agencies, regulatory frameworks, classification and simplified registration pathways, and documentation requirements. Based on international experience, suggestions for improving China's simplified registration management for OTC TCMs were proposed. Results： Regulatory authorities in Japan and the EU have established production standards for traditional medicines based on traditional use experience and specific literature as substantial evidence of safety and efficacy.  For products meeting these standards, non-clinical or clinical trial requirements may be exempted to avoid unnecessary duplication of testing. Conclusions： China should further clarify the categories of TCMs eligible for direct OTC registeration, establish OTC TCM production standards, and appropriately simplify the listing and declaration requirements for TCMs expedite market entry and promote innovation in OTC TCMs.

Reference standards serve as a critical material foundation for drug quality control, and the lawful distribution of the national drug reference standards is one of the core functions of National Institutes for Food and Drug Control (NIFDC). As a driving force for new-quality productivity, big data has improved the precision and intelligence of reference standard distribution management. To improve the efficiency of reference standard management, this study analyzes user demand data, examines distribution workflows, and summarizes pratical applications of big data technologies. This findings indicate that big data technology has a wide range of applications in building a continuous cycle system, optimizing distribution models for  specific  varieties, sorting out the characteristics of distribution methods, integrating packaging and transportation processes, etc. Based on these insights, recommendations are proposed, including establishing an intelligent user feedback system, linking and sharing data between reference substances and drug standards, and optimizing workload allocation. These suggestions provide a reference for further enhancing the efficiency of reference substance management.

Objective: To explore the impact of artificial intelligence (AI) technology on innovation efficiency in the pharmaceutical manufacturing industry. Methods: Based on panel data from 26 provinces in China between 2012 and 2021, this study empirically examined the influence of AI technology on innovation efficiency in pharmaceutical manufacturing using  data enveloping analysis, benchmark regression modeling and threshold effect modeling. Results: The benchmark regression results showed that the regression coefficients of AI technology on R&D efficiency and achievement conversion efficiency were 0.169 and 0.095, respectively. The threshold test results showed a double threshold effect for R&D efficiency and a single threshold effect for outcome transformation efficiency. Conclusion: AI technology significantly promoting effect on the innovation efficiency in the pharmaceutical manufacturing industry, with regional heterogeneity observed. In the era of the digital economy, a significant threshold effect exists between AI technology and pharmaceutical innovation efficiency.

The implementation of China's  drug patent linkage system has established a  crucial platform for the early resolution of patent disputes between originator and generic drugcompanies. This article systematically reviews the patent declaration information of generic drugs registered on the China Listed Drug Patent Information Registration Platform, the drug-related cases published by the China National Intellectual Property Administration, and the judgments published on the China Judgements Online. Focusing on typical cases since the implementation of the drug patent linkage system, the article analyzes the patent declaration strategies employed by generic drug companies, as well as the common defense strategies used in drug patent linkage cases from the perspective of generic drug companies. The study aims to provide practical insights to assist generic drug companies in making more informed and strategic decisions regarding patent declarations within the complex landscape of pharmaceutical patents.

Drug transporters are critical membrane proteins that facilitate the transmembrane transport of drugs, endogenous molecules, and toxins via ATP hydrolysis or ion/concentration gradients. These transporters significantly impact drug absorption, distribution, metabolism, and excretion, and are essential to drug safety and efficacy. They are classified two major families: ATP-binding cassette (ABC) transporters and solute carrier (SLC) transporters. Single nucleotide polymorphisms in transporter genes have a significant influence on drug metabolism and individual variability. In recent years, advances in genomics have led to increasing reports linking transporter gene polymorphisms to differences in drug disposition and clinical efficacy. This paper reviews some key polymorphisms in drug transporters that are associated with anti-cancer drug disposition, with the aim of supporting rational clinical drug use and facilitating personalized anti-cancer therapy.

Eucommia ulmoides Oliv., as a traditional tonic medicinal material in China, has a long history of medicinal use and holds broad prospects for developing medicinal and food homologous products. The plant is rich in iridoids, which have garnered extensive attention and research in recent years due to their structural diversity and pharmacological versatility. To date, 59 iridoid components have been isolated and identified from Eucommia ulmoides Oliv., including 40 glycosides and 19 non-glycosides. Modern pharmacological studies have revealed that these iridoids, as one of the major active constituents,  exhibit a wide range of biological effecte-such as neuroprotective, bone protective, renal- and hepatoprotective, anti-oxidant, anti-inflammatory, anti-tumor, analgesic, anti-atherosclerotic, and anti-hypertensive activities. However, the pharmacological roles of most iridoids from Eucommia ulmoides remain to be further investigated and systematically elucidated. This review summarizes the chemical structures, varieties and pharmacological effects of iridoids of Eucommia ulmoides Oliv., aiming to provide a scientific basis for future studies on their pharmacological mechanisms and structure-activity relationships, as well as to establish a theoretical foundation for guiding the development of new drugs and drug-food homologous products.

Alopecia areata is a prevalent chronic tissue-specific autoimmune disorder characterized by the destruction of hair follicles and unpredictable hair loss on the scalp and other body areas. Studies have shown that Janus kinase (JAK) acts as a key factor in immune activation in the pathogenesis of alopecia areata. Deuruxolitinib (LEQSELVI), a novel deuterated JAK1/2 inhibitor, was approved by the US FDA on July 25, 2024, for the treatment of severe alopecia areata in adults. Several clinical trials have demonstrated hair regrowth in patients with severe alopecia areata following deuruxolitinib treatment, with an overall favorable safety and tolerability profile. This article introduces its pharmacological effects, pharmacokinetics, clinical research, safety and drug use in special populations.

Objective: To evaluate the bioequivalence of clarithromycin tablets in healthy Chinese subjects. Methods: Two separate studies were conducted—a fasting study and a fed study—each involving 52 healthy subjects. Both studies employed a two-period, complete repetition, and self-crossover design. Subjects received a single oral dose (0.25 g) of either the test or reference clarithromycin tablet.  The plasma concentrations of clarithromycin were determined using Liquid chromatography-mass spectrometry (LC-MS). Pharmacokinetic parameters and relative bioavailability were calculated with WinNonlin8.1 software to assess bioequivalence between the two preparations. Results: Under fasting conditions, the main pharmacokinetics parameters (mean±SD) for the test and reference preparations were as follows:  
C_max (1 219.26±446.14) vs (1 179.41±473.28) ng·mL^－1; AUC_0-t (6 285.38±2 021.53) vs (6 311.37±2 212.95) h·ng·mL^－1; AUC_0-∞ (6 453.49±2 041.59) vs (6 619.14±2 335.67) h·ng·mL^－1. Under fed conditions, the corresponding values were: C_max (1 587.32±628.76) vs (1 492.28±573.62) ng·mL^－1; AUC_0-t (7 053.24±2 436.54) vs (6 714.95±2 193.32) h·ng·mL^－1; AUC_0-∞ (7 253.08±2 510.36) vs (6 959.44±2 206.17) h·ng·mL^－1. The 90% confidence intervals for the geometric mean ratios of C_max, AUC_0-t, and AUC_0-∞ for both fasting and fed studies fell entirely within the accepted bioequivalence range of 80.00%～125.00%. Conclusion: The test and reference clarithromycin tablets are bioequivalent in healthy Chinese subjects under fasting and fed conditions.

Objective: To evaluate the lipid-lowering efficacy and safety of inclisiran in patients with atherosclerotic cardiovascular disease (ASCVD) across different risk strata. Methods: This single-center retrospective study enrolled 54 patients treated with inclisiran in the Department of Cardiology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, between October 2023 and August 2024. The reduction in low density lipoprotein cholesterol (LDL-C) levels, safety profile, and goal attainment rates stratified by ASCVD risk were assessed at 3 and 9 months. Efficacy was also compared between subgroups: coronary heart disease (CHD) vs non CHD, and primary vs secondary prevention. Results: In the overall population, LDL-C reductions after 3 and 9 months of inclisiran treatment were 53.21% and 58.79%, respectively (both P<0.001). Consistent reductions were observed across all subgroups. Goal-attainment rates according to risk stratification were as follows: 90.9% in the very high-risk group, 55.0% in the high-risk group, 66.7% in the moderate-to-high-risk group, and 78.6% in the low-risk group. Liver and kidney function indices remained stable overall, with no significant adverse reactions observed. Conclusion: Inclisiran-based combination lipid-lowering therapy demonstrates significant and safe reduction in LDL-C levels in ASCVD patients across different risk categories, with efficacy increasing over the treatment duration.

Objective: To establish a method for detecting target gene profiles of herbal-derived microRNAs (miRNAs) in mice lung tissue and to apply this method to analyze the target gene profile and biological functions of miR-320 contained in Qingfei Paidu Decoction (QFPD), thereby providing miR-level mechanistic insights into its therapeutic effects against viral pneumonia. Methods: Second-generation high-throughput sequencing was used to quantify the expression of the target miRNA (miR-320) in QFPD. The “Capturing and Sequencing of miRNA-target Complex Technology (CSCT)” was employed to preliminarily identify its target gene profile in mice lung tissue, followed by validation using AlphaFold3. The overlapping results were identified as the definitive target gene profile of miR-320. Functional enrichment analysis was performed to elucidate the regulatory role of QFPD mediated by miR-320 in mice lung tissue. The detection results were compared with TargetScan predictions to evaluate the advantages of the proposed sequential detecntion method (CSCT+AlphaFold3). Results: High-throughput sequencing revealed abundant miR-320 in QFPD, with its expression level ranked among the top 50 miRNAs. In mice lung tissues, miR-320 targeted 26 gene classes, including 19 annotated genes (18 mRNAs and 1 transcriptional enhancer). Through canonical miRNA-mRNA recognition, miR-320 exhibits strong base complementarity with all 26 targets, with minimum free energy values ranging from -35.8 to -21.8 kcal·mol^－1. AlphaFold3 predictions yielded a minimum combined ipTM+pTM score of 1.1 (within the high-confidence range), providing complete validation (100%) of the CSCT (Computational Small RNA Target Identification) results. This confirms these 26 gene classes as the functional spectrum of miR-320. Compared with TargetScan, the “CSCT+AlphaFold3 Sequential Detection Method” developed in this study demonstrated superior accuracy. Functional analysis revealed that the target genes are mainly enriched in interleukin mediated immune signaling pathways, involved in antigen processing and presentation, immune factor/cell mediated apoptosis, and lymphocyte proliferation/activation. Conclusion: miR-320 from QFPD predominantly regulates immune-related pathways in mice lung tissue, which may represent one of the miRNA mediated mechanisms underlying QFPD's efficacy against viral pneumonia. The developed “CSCT+AlphaFold3” method exhibits high reliability and accuracy for detecting miRNA-target interaction profiles and can serve as a robust technique for studying miRNA mediated regulation in traditional Chinese medicine decoctions.

Objective: To develop a quantitative structure-activity relationship (QSAR) liver toxicity prediction and evaluation method for medicinal and food homologous (MFH) substances, and apply it to the liver toxicity evaluation of Ginkgo biloba and Polygonum multiflorum. Methods: A total of 1 110 compounds with hepatotoxic adverse reactions were collected from the SIDER database (SIDER 4.1, released on October, 2015) and LiverTox (updated on March, 2025) as positive datasets, and 312 compounds that do not cause liver damage from DILIrank (updated on September, 2023) as negative datasets. Stone MIND Collector software was used to convert the collected compound molecule images into SMILES format, and then a hepatotoxicity model was constructed using Inno QSAR on the DrugFlow platform. The accuracy and robustness of the QSAR hepatotoxicity model were verified using 5-fold cross validation. Then, 72 compounds contained in Ginkgo biloba and 25 compounds contained in Polygonum multiflorum were collected and integrated from the TCMSP (Version 2.3, updated on May, 2014) database and Yaozhiwang database (updated on quarter 3rd) for screening. The QSAR hepatotoxicity model was used to predict and evaluate the hepatotoxicity of the two medicinal substances. Results: The fitting evaluation of the constructed QSAR hepatotoxicity model showed an ACC of 0.809, ROC-AUC of 0.757, close to 1. The F1 score value was 0.888, indicating that the model has high accuracy and precision, good model performance, and high predictability. The prediction results showed that both Ginkgo biloba and Polygonum multiflorum are substances that may cause liver toxicity. The hepatotoxicity caused by Ginkgo biloba is most likely related to the compounds cardanol (C₂₁H₃₄O), amentoflavone (C₃₀H₁₈O₁₀), ginkgolide B (C₂₀H₂₄O₁₀), and ginkgolide J (C₂₀H₂₄O₁₀). The hepatotoxicity caused by Polygonum multiflorum is most likely related to the compounds pyrogallol (C₆H₆O₃), 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside (C₂₀H₂₂O₉), and citreorosein (C₁₅H₁₀O₆). Conclusion: The QSAR liver toxicity prediction and evaluation method for MFH substances established in this study aims to explore and evaluate the liver toxicity of food and drug substances more deeply and finely, providing data reference for early identification and warning.

Objective: To establish an HPLC fingerprint of Codonopsis pilosula Oral Liquid and simultaneously determine the contents of Syringin, Codonopsis alkynin, Codonopsis alkynyl glycoside, Codonopsis pilosula alkynyl alcohol, Atractylodes lactone Ⅲ for quality evaluation. Methods: Chromatographic separation was performed on a DiKMAC₁₈ column (250 mm×4.6 mm，5 μm) using a gradient elution of acetonitrile and 0.1% acetic acid solution as the mobile phase. The flow rate was 1.0 mL·min^－1, the column temperature was maintained at 25 ℃, detection wavelengths were set at 220, 215, and 267 nm, and the injection volume was 20 μL. Results: The established fingerprint showed 10 common peaks, with similarity values among different batches exceeding 0.981. The contents of Syringin, Codonopsis alkynin, Codonopsis alkynyl glycoside, Codonopsis pilosula alkynyl alcohol and Atractylodes lactone Ⅲ were 0.032~0.054, 0.030~0.041, 0.066~0.112, 0.006~0.013, 0.005~0.010 mg·mL^－1, respectively. The five compounds exhibited good linearity (r≥0.9991) within their respective concentration ranges. The relative standard deviations (RSDs) for precision, repeatability, and 24-h stability were all below 3.000%. The average recoveries ranged from 97.701% to 101.636%, with RSDs between 1.347% and 2.551%. Conclusion: This method is stable, scientifically sound and reproducible, providing a scientific basis for improving the quality evaluation method of Codonopsis pilosula Oral Liquid.

Objective: To establish methods for determining the contents of mercury and arsenic, and for analyzing valence mercury and arsenic in Niuhuang Qingxin Pills (Bureau), and to assess the potential health risks to humans. Methods: Mercury content was determined by titration, arsenic content by atomic fluorescence spectroscopy (AFS), and mercury/arsenic speciation by high-performance liquid chromatography-inductively coupled plasma mass spectrometry (HPLC-ICP-MS). Results: Among the 29 batches tested, the content of mercury ranged 12.11~23.22 mg·g^－1, with 6 batches exceeding the specified limit. The content of arsenic ranged 3.76~5.02 mg·g^－1, all within the acceptable limit. Speciated mercury and arsenic were not detected in any sample. Conclusion: Titration, AFS and HPLC-ICP-MS are highly sensitive, rapid and accurate methods suitable for content determination of mercury and arsenic in Chinese patent medicine. The findings provide a scientific basis for the safety evaluation of other traditional medicines containing cinnabar or realgar.