20 October 2026, Volume 40 Issue 10
    

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    Supervision & Administration
  • Reflections on the Evaluation Framework for Artificial Intelligence-Generated Clinical Evidence in Drug Regulation
    Li Min, Fan Yi, Pan Jianhong, Cao Shang, Wang Jingzhao, Yu Huan
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1161-1170. https://doi.org/10.16153/j.1002-7777.2026-05-0025
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    Objective：Grounded in China's drug regulatory practice, this study examined methods for scientifically evaluating the validity, reliability, and interpretability of artificial intelligence (AI)-generated evidence, with the aim of offering reviewers an actionable evaluation path and providing sponsors with scientific guidance for standardizing the generation of AI evidence. Methods：The study reviewed the policy documents and guidance issued by regulatory authorities to systematically analyze the core challenges in evaluating AI-generated clinical evidence, on the basis of which a methodological framework for such evaluation was proposed. Results：Although AI-generated evidence plays an increasingly prominent role in drug regulatory decision-making, considerable challenges remain. Three core difficulties—the heterogeneity of the objects under evaluation, the complexity of data, and change management arising from the dynamic updating of AI models—were identified. Accordingly, an analytical framework organized around four sequential pillars—context of use (COU) definition, risk categorization, model credibility assessment, and lifecycle management—was proposed, specifying a context-driven evaluation logic, risk-based differentiated evidence requirements, a stratified credibility validation strategy, and dynamic governance mechanisms. Conclusion：The framework offers practical value for establishing a human-AI collaborative review and approval system and for advancing the regulatory shift from post-hoc verification to pre-emptive prediction. It provides a theoretical reference for refining the methodology of AI clinical evidence evaluation and accelerating the intelligent transformation of drug regulation.
  • Comparative Analysis and Recommendations for China’s Policies on the Integrated Operation of Pharmaceutical Wholesale and Retail
    Wang Xiuyun, Chen Dandan, Liao Qian
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1171-1178. https://doi.org/10.16153/j.1002-7777.2025-05-0023
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    Objective：To conduct a comparative analysis of the policies on the integrated operation of pharmaceutical wholesale and retail that have been introduced across various provinces, and to discuss and analyze them in conjunction with practical work experience, so as to provide a reference for the subsequent refinement of policies related to the integrated operation of pharmaceutical wholesale and retail and the formulation of on-site inspection guidelines. Methods：By searching the websites of the National Medical Products Administration and provincial medical products administrations, the study collected and collated the policies on the integrated operation of pharmaceutical wholesale and retail from 23 provinces. The commonalities and differences among these policies were compared and analyzed, and recommendations were proposed. Results：The policies on the integrated operation of pharmaceutical wholesale and retail in the 23 provinces mainly focus on aspects including the quality management systems, organizational structure and responsibilities, personnel, computer systems, facilities and equipment, and quality management, with certain differences observed in specific provisions. Issues that require further clarification were identified in the relevant policies, such as unclear requirements for organizational setup and responsibilities, inconsistencies in staffing and qualification requirements, and insufficiently specific requirements for quality management system documentation. Conclusion：It is recommended that the pharmaceutical regulatory authorities establish on-site inspection guidelines for enterprises engaged in the integrated operation of pharmaceutical wholesale and retail and strengthen routine supervision and inspection. Enterprises engaged in the integrated operation of pharmaceutical wholesale and retail should assume their primary responsibilities and enhance their capabilities through multiple dimensions, thereby promoting the standardized development of the integrated operation of pharmaceutical wholesale and retail.
  • Inspection Methods and Graded Risk Control for Data Integrity of LIMS and MES in Pharmaceutical Production
    Li Zimu, Li Sumei
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1179-1186. https://doi.org/10.16153/j.1002-7777.2026-06-0029
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    Objective：To establish inspection methods for data integrity of the Laboratory Information Management System (LIMS) and Manufacturing Execution System (MES) in pharmaceutical production, implement graded risk control, standardize system data management, and prevent irregular data risks, thus ensuring pharmaceutical quality and safety. Methods：According to the Good Manufacturing Practice for Pharmaceutical Products and the Requirements for Drug Records and Data Management (Trial), this paper sorted out the core functions and data flow logic of LIMS and MES and summarized typical defects identified during on-site inspections. A full-process inspection and risk control system covering regulatory basis, inspection procedures, defect identification, and graded risk control was established. The feasibility of the proposed system was verified through practical on-site inspection cases. Results：Key inspection points and procedural steps for inspection of data integrity of LIMS and MES were clarified. Eight categories of typical defects, including system validation, authority management, and audit trail, were identified. A three-tier (high, medium, and low) risk classification standard together with corresponding control measures was formulated. Conclusion：The proposed inspection methods and graded risk control system possess strong practical operability. It can provide references for on-site inspections by drug regulatory authorities and compliance management of pharmaceutical manufacturers, help improve the data integrity in pharmaceutical production, and safeguard pharmaceutical quality and safety.
  • Quality Control Strategies for Continuous Manufacturing of Chemical Drugs under ICH Q13
    Yue Ruiqi, Li Huiyi
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1187-1192. https://doi.org/10.16153/j.1002-7777.2026-07-0042
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    Objective：To analyze the rationale and key technical elements of quality control strategies for continuous manufacturing of chemical drugs under ICH Q13, thus informing development, regulatory submission, and commercial operation. Methods：ICH Q13, related quality guidelines, and Chinese and international literature on continuous manufacturing were reviewed to examine regulatory requirements and synthesize the roles and interrelationships of process understanding, layered control, residence time distribution, material traceability, process analytical technology, real-time release testing, continued process verification, transient disturbance control, and the pharmaceutical quality system. Results：Quality control in continuous manufacturing requires coordinated material control, engineering control, quality monitoring, and quality decision-making to establish a chain of quality evidence across development, production, and lifecycle management. Relationships among critical material attributes, critical process parameters, intermediate quality attributes, and critical quality attributes provide the scientific basis. Residence time distribution and material traceability define batch boundaries and the extent of affected material, while process analytical technology and model-based control support process monitoring and adjustment. Predefined procedures for managing transient disturbances, real-time release testing, continued process verification, and the pharmaceutical quality system jointly support material disposition, release decisions, and maintenance of a state of control. Conclusion：Control strategies for continuous manufacturing of chemical drugs should be tailored to product characteristics, process features, and risk levels, with technical and management requirements integrated through a chain of quality evidence. Chinese manufacturers should plan material attribute studies, process analytical technology methods, residence time distribution studies, model lifecycle management, and computerized system validation early in development, and clarify the boundaries of control strategies and post-approval change paths through regulatory communication.
  • Design of an Intelligent Drug Testing Information System with Samples as the Main Line
    Zhang Weimin, Li Xiuji, Kang Shuai, Hu Xiaowen, Dong Zhongping, Zhong Xuanwei
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1193-1199. https://doi.org/10.16153/j.1002-7777.2026-03-0041
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    Objective：To address the challenges faced by drug testing institutions, including complex testing processes, dispersed system functions, and difficulty in full-process traceability of sample information, and to propose the design concept and path for an Intelligent Drug Testing Information System (IDTIS) that takes samples as the main line and integrates artificial intelligence technology. Methods：The full-process business requirements of samples from reception, testing to disposal were systematically analyzed. An IDTIS architecture was constructed with a sample information model as the core, process traceability as the link, and data integration as the support. Artificial intelligence technology was introduced by independently building data resources such as audit rule bases and regulatory standard knowledge bases, along with configuring corresponding computing power. Furthermore, the design of IDTIS and the development path of intelligent drug testing were explored from the dimensions of sample information model design, process collaboration mechanism, data traceability system, and key technology application. Results and Conclusion：The IDTIS, which takes samples as the main line and integrates artificial intelligence technology, achieves full-process information integration and business collaboration in drug testing, effectively addressing challenges such as complex processes, dispersed functions, and traceability difficulties. It provides a feasible path for the transition from digital to digital-intelligent drug testing, driving the digital-intelligent transformation of drug testing and providing a reference for the systematic upgrading of drug testing institutions.
  • Post-Marketing Change Management Policy Analysis of Autologous CAR-T Therapy Products in China, the United States, and the European Union
    Li Yingmeng, Shi Wenyu, Yao Dongning, Zhang Liying
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1200-1211. https://doi.org/10.16153/j.1002-7777.2025-12-0011
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    Objective：To evaluate the alignment between China’s current risk-based change classification and management system and the practical requirements of technical review based on a comparison of the regulatory frameworks for post-marketing changes to autologous chimeric antigen receptor T-cell (CAR-T) therapy products in China, the United States, and the European Union, thus informing improvements in the regulatory framework and the development of change submission strategies by companies. Methods：By reviewing the regulations, guidelines, publicly available statistical data, and industry reports released by regulatory authorities in China, the United States, and the European Union, this study adopted a literature analysis, a comparative study approach, and a case study method to summarize and compare the classification systems, submission pathways, technical requirements, and implementation status of post-marketing changes across these regions. Results：China has established a preliminary classification framework for post-marketing changes to autologous CAR-T products. The case studies indicated that the strength of evidence required for different types of changes was closely related to their potential impact on critical quality attributes and the residual uncertainty. In practice, however, limited batch numbers and interindividual variability constrain CMC comparability studies. The applicability of supplementary evidence requires case-by-case, risk-based assessment. Practical experience remains to be accumulated regarding the coordination of filing dossier review with inspection and testing under the current regulatory framework. Conclusion：On the basis of product risk and the adequacy of supporting evidence, the technical evaluation requirements for post-marketing changes to autologous CAR-T products should be further refined, and the coordination between post-marketing dossier review and inspection and testing should be standardized. Pre-submission communication and case sharing should also be strengthened to improve the scientific rigor, predictability, and efficiency of change management.
  • Discussion and Practical Prospects of Constructing a Digital Intelligence-Based Medical Device and Drug-Device Combination Products Classification Management System
    Wang Yue, Zheng Jia, Jiang Xiao, Cui Le, Zhang Chunqing, Zhu Jiong
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1212-1219. https://doi.org/10.16153/j.1002-7777.2025-10-0058
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    Objective：The challenges posed by the deep application of new generation information technologies to traditional medical device classification management are addressed, and new approaches for the scientific development of regulatory science are provided. Methods：The dilemmas of the current classification system were analyzed. The necessity and feasibility of constructing a new classification management system were explored using digital-intelligent technologies, with a particular focus on the structural contradictions arising from cross-boundary integrated products such as drug-device combination products. Results and Conclusion：The current system faces three dilemmas: the failure of “feature matching”, the disconnect between static rules and rapid technology iteration, and the lagging cognitive updates. This paper proposes a framework that features deep cognition via knowledge graphs, risk traceability via causal inference, and dynamic rule iteration via virtual rehearsal, and constructs three core architectures: intelligent pre-classification, dynamic early warning, and a classification database, thereby forming a digital-intelligent classification management system characterized by data-driven operation, human-machine collaboration, and dynamic optimization. For cross-boundary integrated products such as drug-device combination products, the rules, data, and risk signals of drugs and medical devices should be integrated into a unified knowledge graph and classification database to assist in attribute determination and classification pathway judgment. Implementation should be supported by data standardization, security compliance, and human-machine collaboration, and advanced through pilot projects in a stepwise manner. The system is necessary and feasible, and can help improve the efficiency of classification management; however, it still requires ongoing validation in terms of interpretability, data quality, and regulatory adaptability.
    • Regulatory Science for Innovative Drugs
  • Clinical Considerations on the Research and Development of New Traditional Chinese Medicine Compound Preparations for Premature Ventricular Contractions without Structural Heart Disease
    Zhao Zhihong, An Na
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1220-1223. https://doi.org/10.16153/j.1002-7777.2026-04-0050
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    Objective：To explore the key technical considerations in the research and development of new traditional Chinese medicine (TCM) compound preparations for premature ventricular contractions without structural heart disease. Methods：On the basis of a review of related literature at home and abroad, the characteristics of the disease and TCM treatment, and the research and development concept combining the theory of TCM, human experience, and clinical trials, this paper put forward suggestions on the technical considerations of key links in the research and development of new TCM compound preparations for premature ventricular contractions without structural heart disease. Results and Conclusion：Premature ventricular contractions without structural heart disease are a common type of premature ventricular contractions in clinical practice. The efficacy of available clinical drugs is limited, and there are unmet treatment needs. In clinical practice, TCM treatment based on syndrome differentiation from a holistic view has certain advantages and characteristics in alleviating clinical symptoms and improving quality of life. For the research and development of new TCM compound preparations for this disease, clinical position can be identified based on TCM theory and TCM clinical practice. In addition, clinical research design can be based on the concept of patient-centered drug research and development, with alleviating symptoms as the clinical position, and appropriate efficacy evaluation indicators such as symptom disappearance rate can be selected to evaluate its efficacy.
    • Assessment Techniques & Guidance: Special Column on Technical Assessment of Biologics
  • Significance and Challenges of Stability Studies for Biological Products
    Qiu Xiao, Yang Fei, Guo Shuyang, Wei Wei
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1224-1229. https://doi.org/10.16153/j.1002-7777.2026-08-0035
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    Objective：To clarify the significance of stability studies and elaborate on the special considerations and current challenges in the stability studies for biological products. Methods：According to the characteristics of biological products, the scientific basis for the low stability and easy degradability of such products was elucidated. By reviewing different regulatory guidelines relating to stability studies, we identified the significance of different stability studies for the life-cycle management of biological products. In addition, we summarized the contents of stability studies required at various stages throughout the life-cycle management, and put forward some special considerations for biological product stability studies. Finally, in response to the challenges currently encountered in the development of biological products, we proposed some suggestions. Results and Conclusion：Stability studies are of great significance to the life-cycle management of biological products. Scientifically and rationally designed stability studies can accelerate the product development process and improve the overall efficiency of life-cycle management.
  • Current Status and Key Considerations for Clinical Research and Development of Human Papillomavirus Vaccines
    Liu Yalin, Lu Shuang
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1230-1238. https://doi.org/10.16153/j.1002-7777.2026-09-0006
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    Human papillomavirus (HPV) infection imposes a substantial disease burden, with more than one million new cases of HPV-related cancer and hundreds of thousands of related deaths worldwide each year. HPV vaccines are the most economical and effective means of preventing and controlling diseases caused by HPV infection. Since the approval of the world’s first HPV vaccine in 2006, significant progress has been made in HPV vaccine research and development (R&D) both in China and abroad. This article reviews the current status of HPV vaccine marketing approval and R&D and, in conjunction with the technical guidelines for vaccine clinical trials issued in China and relevant regulatory requirements, systematically discusses key considerations in clinical research and development of HPV vaccines, including indications and primary clinical trial endpoints, target vaccination populations and study populations, HPV type coverage and iterative development strategies, and safety evaluation. The aim is to provide a reference for vaccine developers and relevant researchers in formulating clinical research and development strategies. Currently, HPV vaccine R&D in China is gradually shifting toward the development of higher-valency vaccines. The proposal of iterative strategies may significantly accelerate the clinical research and development of higher-valency HPV vaccines. However, vaccine developers should fully assess and recognize the challenges associated with the similarity of the material basis when adopting such strategies, as well as those related to clinical trial implementation and management.
  • Pharmaceutical Research and Evaluation of Human Stem Cell-Derived Extracellular Vesicle Therapeutics
    Wang Jingyu, Cui Jing, Wang Xue, Gong Xu, Dong Jing, Lu Jiaqi, Wei Wei
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1239-1246. https://doi.org/10.16153/j.1002-7777.2026-08-0015
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    Human Stem cell-derived extracellular vesicles (EVs), as derivatives of stem cells, possess multiple advantages, including low immunogenicity and high tissue compatibility, and have shown broad application prospects in tissue repair, immunomodulation, and neural regeneration. However, owing to their inherent heterogeneity, compositional complexity, and high sensitivity to manufacturing processes, the pharmaceutical research of EVs faces numerous challenges, and their clinical translation remains bottlenecked. Based on the biological characteristics of EVs and current research knowledge, this article summarizes the key issues that require attention in the pharmaceutical research of human stem cell-derived EV therapeutics, including production cells, cell culture and purification processes, formulation development, quality research, and stability studies, with the aim of providing a reference for the research and development of related products. Developers should, based on product characteristics and risks, continuously accumulate sufficient pharmaceutical research data and gradually establish and improve a scientific pharmaceutical research and evaluation system, thereby laying a foundation for the translation of EV therapeutics from the laboratory to the clinic.
  • Application of Artificial Intelligence in CMC Research and Evaluation of Biosimilars
    Sai Wenbo, Tian Baojun, Wei Wei
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1247-1253. https://doi.org/10.16153/j.1002-7777.2026-08-0053
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    Objective：To provide insights into the application prospects of artificial intelligence (AI)-assisted tools in the research and development (R&D), manufacturing, and regulatory process of biosimilars. Methods：The application progress of AI-assisted tools by major global pharmaceutical regulatory authorities and in the R&D and manufacturing of biosimilars was reviewed. The application prospects of AI-assisted tools in the Chemistry, Manufacturing, and Controls (CMC) research and evaluation of biosimilars were analyzed. Anticipated applications and potential practical examples were further proposed for analytic similarity assessment and exemption of comparative efficacy study, and the actual challenges faced by the implementation of such tools in practice were summarized and discussed. Results and Conclusion：Massive datasets generated throughout the R&D and manufacturing process of biosimilars fit well with the application scenarios of AI-assisted tools. These tools can integrate multi-dimensional quality analysis datasets, quantitatively resolve molecular modification characteristics, and construct standard quality characterization profiles, thereby advancing digital and precise control over similarity evaluation. Despite numerous challenges remaining for AI-assisted regulatory review, including training dataset screening, software-hardware confidentiality management and control, and result bias correction, such tools possess broad application potential. They can lay a foundation for building up China’s strength in pharmaceutical manufacturing and producing greater benefits for patients.
  • Pharmaceutical Research Progress and Review Considerations of Human Fibrinogen
    Jia Yanhua, Wu Zhouyi, Yu Pengli, Jia Dongchen
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1254-1259. https://doi.org/10.16153/j.1002-7777.2026-08-0050
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    Objective：To guide the blood product manufacturers in the research and development of human fibrinogen products, thus providing a reference for process optimization and quality improvement of human fibrinogen in China from a technical perspective. Methods：On the basis of previous technical review cases in China, pharmaceutical literature on human fibrinogen, and technical guidelines for blood products, this article summarizes the research requirements and reporting materials for human fibrinogen from a pharmaceutical evaluation perspective. Results and Conclusion：This article systematically summarizes product features of human fibrinogen, the overview of marketed products, viral safety control strategies, key quality control considerations, and the current status of manufacturing processes. In light of common issues encountered in the technical evaluation of human fibrinogen, it further highlights key aspects warranting attention in the regulatory review. These findings are expected to clarify the current research status and key issues in pharmaceutical studies of human fibrinogen in China.
  • Research Progress and Nonclinical Evaluation Considerations on Drugs for Duchenne Muscular Dystrophy
    Rong Yi, Fu Shujun, Wang Shiqi, Rao Zijian, Sun Tao
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1260-1271. https://doi.org/10.16153/j.1002-7777.2026-08-0002
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    Objective：To review the research and development progress of drugs for Duchenne muscular dystrophy (DMD), analyze the key issues in the nonclinical evaluation of various drugs from a pharmacological and toxicological perspective, and provide references for the nonclinical research and evaluation of DMD drugs in China. Methods：Publicly available review documents and references for approved DMD drugs worldwide were systematically reviewed. The nonclinical study designs, major findings, and regulatory considerations of drugs developed through different technical approaches were summarized. Results and Conclusion：The development of DMD drugs has gradually shifted from hormone-based supportive therapy to targeted interventions at the genetic level. Various novel therapies face unique challenges in nonclinical studies. In the context of rare diseases, regulatory agencies allow appropriate simplification of studies; however, this should be based on adequate risk control. During drug development, attention should be paid to the selection of animal models and species, comprehensive characterization of target organ toxicity, design of juvenile animal studies, and validation of the correlation between animal endpoints and clinical benefits.
    • Technical Research
  • Methodological Comparison and Consistency Study of High-Throughput and Classic FAMA Slide Assays for Detecting Varicella-Zoster Virus Antibodies
    Quan Yaru, Yang Xian, Chen Zhen, Nie Jiaojiao, Qiu Ping, Han Jinle, Song Miaomiao, Geng Xingchao
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1272-1283. https://doi.org/10.16153/j.1002-7777.2026-08-0051
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    Objective：To establish a high-throughput fluorescent antibody to membrane antigen (FAMA) assay (high-throughput FAMA) and conduct a systematic methodological comparison and consistency study with the classic FAMA slide assay, thereby evaluating its feasibility for varicella-zoster virus (VZV) antibody detection and as an alternative method in vaccine clinical trials. Methods：High-throughput FAMA and classic FAMA slide assays were performed in parallel to test 1278 serum samples from four independent varicella/herpes zoster vaccine clinical trials. Optimal cut-off values for the high-throughput FAMA were established through receiver operating characteristic (ROC) curves. The two methods were systematically compared and evaluated across data distribution characteristics, qualitative agreement, semi-quantitative agreement (quadratically weighted Kappa coefficient), quantitative correlation, quantitative agreement, and the post-immunization four-fold antibody rise rate. Results：The optimal cut-off values for the high-throughput FAMA assay at 1∶8, 1∶16, and 1∶32 dilutions were 342, 41, and 13, respectively (all AUCs>0.94). This method showed improved automation and intelligence, and thus enhanced testing efficiency compared with the classic method, with superior data normality. Qualitative consistency analysis showed an overall agreement rate of 89.4% (ROC AUC=0.933). The semi-quantitative quadratically weighted Kappa coefficient on the ordered titer gradient was 0.8179 (95% CI: 0.7994-0.8363). Quantitative analysis indicated no significant proportional or systematic bias. In clinical determination, the overall agreement rate of the two methods for identifying a post-immunization four-fold antibody rise reached 91.0%. Conclusion：The high-throughput FAMA assay exhibits good qualitative, semi-quantitative, and quantitative consistency with the classic FAMA slide assay. With advantages in automation, high throughput, and objective traceability, this method may serve as a promising high-throughput alternative for large-scale VZV serum antibody screening and vaccine immunogenicity evaluation in clinical practice.
    • Research Progress
  • Impact Analysis and Related Considerations of Blood Sampling Design on Pharmacokinetic Endpoint Bioequivalence Studies
    Wang Yan, Yan Fang, Han Hongcan, Gao Lili, Zhong Lanping, Wei Chunmin, He Ruirui, Li Min
    Chinese Pharmaceutical Affairs. 2026, 40(10): 1284-1290. https://doi.org/10.16153/j.1002-7777.2026-04-0020
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    Objective：To focus on the design of blood sampling in pharmacokinetic endpoint bioequivalence (PK-BE) studies and analyze the impact of related design deficiencies on the conclusions of equivalence studies based on actual research cases and within the framework of guideline requirements, and discuss relevant considerations and recommendations to provide references for generic drug development. Methods：Common inappropriate design issues identified in actual PK-BE study cases were categorized and illustrated, including insufficient total sampling duration, inappropriate setting of the first post-dose sampling time point, and mismatch between the density of sampling points and drug release behavior. The potential impact of deficiencies in blood sampling design on the conclusions of equivalence studies was explored, and corresponding scientific considerations and recommendations were discussed. In addition, blood sampling strategies for complex generic drugs were preliminarily explored using long-acting special formulations and enteric-coated extended-release formulations as examples. The importance of scientific clinical trial design in determining bioequivalence conclusions was emphasized. Results and Conclusion：The appropriateness of blood sampling design directly affects the reliability of conclusions from generic drug equivalence studies. Global advanced regulatory authorities have identified deficiencies in blood sampling design as important technical risk factors leading to failures of bioequivalence studies. The National Medical Products Administration (NMPA) has also recently issued relevant guidelines emphasizing the concept of “quality by design” in clinical research. With the increasing complexity of molecular types and dosage forms of generic drugs and the growing challenges in generic development, this study uses deficiencies in blood sampling design as an example to discuss relevant scientific considerations in conjunction with guideline requirements. Scientific clinical trial design is a fundamental cornerstone for ensuring reliable bioequivalence study conclusions and an important safeguard for accurate regulatory evaluation. Furthermore, bioequivalence study design requires comprehensive and systematic considerations. Research protocols should be developed based on a thorough understanding of the characteristics of the reference drug and the integration of multiple research aspects to ensure the robustness of study results and facilitate successful regulatory submission.
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