Expert Q&A – media

【EXPERT Q&A】What are the advantages and disadvantages of the implementation of drug test data protection management measures?

Drugdu.com expert’s response: The implementation of the Measures for the Protection and Management of Drug Trial Data has significant dual advantages and disadvantages, requiring comprehensive assessment from multiple dimensions including institutional innovation, market competition, and patient needs. The following analysis is based on specific cases and policy logic: I. Core Benefits: Driving Innovation and Regulating the Market Innovation Incentives and Long-term Investment Guarantee Market Exclusivity Period Forms a Return Loop: Innovative drug companies need to invest decades of time and hundreds of millions of dollars in clinical trials. Data protection ensures they can recover costs and obtain reasonable profits through a market exclusivity period of 6-12 years (e.g., Keppra was approved for marketing in over 90 countries through protection), enabling continuous investment in the next generation of drug development. First Generic Drug Incentives Fill Gaps: Providing a 3-year data protection period for the first generic drug (e.g., the first generic ...
- Source: drugdu
- 32
- April 4, 2025
【EXPERT Q&A】What is the difference between siRNA and shRNA in RNA interference technology?

Drugdu.com expert’s response: I. Molecular Structure and Synthesis siRNA: A chemically synthesized or in vitrotranscribed double-stranded RNA molecule, comprising 21–23 base pairs with 2–3 nucleotide overhangs at both ends. Directly delivered to the cytoplasm, where it binds to the RNA-induced silencing complex (RISC) to guide targeted mRNA cleavage. Rapid onset of action (within hours) but has a shorter half-life (typically hours to two days), requiring repeated dosing. Recent advancements in chemical modifications (e.g., 2′-O-methylation, phosphorothioate bonds) have extended stability to ~1 week. Systemic delivery still relies on lipid nanoparticles or GalNAc conjugation for tissue targeting. shRNA: A single-stranded RNA delivered via plasmid or viral vectors. Its hairpin structure is transcribed by RNA polymerase III (Pol III) in the nucleus and processed by Dicer enzyme into functional siRNA. Delayed onset (24–72 hours) but offers sustained gene silencing for weeks to months. Ideal for stable gene knockdown models (e.g., neurodegenerative disease studies using ...
- Source: drugdu
- 40
- April 2, 2025
【EXPERT Q&A】What is Antibody-polypeptide Conjugate (APC)?

Drugdu.com expert’s response: Antibody-Peptide Conjugate (APC) is a specialized biopharmaceutical that links an antibody with a peptide through specific chemical bonds. This conjugate combines the targeting properties of the antibody with the biological activity of the peptide, enabling precise treatment of specific cells or tissues. Below is a detailed explanation of Antibody-Peptide Conjugate (APC): I. Definition and Structure Antibody-Peptide Conjugate (APC) is a complex formed by chemically linking an antibody and a peptide. The antibody is responsible for recognizing and binding to specific antigens on target cells or tissues, while the peptide carries therapeutically active molecules or groups. This structure allows APC to precisely target diseased sites while releasing therapeutic peptides, achieving localized high-concentration drug treatment. II. Preparation and Application Preparation Method: Antibody Reduction: Firstly, the interchain disulfide bonds of the antibody are reduced to produce thiol groups, providing active sites for subsequent conjugation reactions. Peptide Conjugation: Then, the chemically modified ...
- Source: drugdu
- 45
- March 31, 2025
【EXPERT Q&A】What is the difference between fsma certification and brc certification?

Drugdu.com expert’s response: FSMA certification and BRC certification both occupy an important position in the food industry, but they differ significantly in multiple aspects. Here are the main differences between the two: I. Establishing Institution and Background FSMA certification: Implemented by the U.S. Food and Drug Administration (FDA), it stands for Food Safety Modernization Act certification. This certification was developed in response to the rapid changes in the global food system and the challenge of foodborne illnesses, aiming to ensure the safety of the food supply chain through preventive measures. BRC certification: Established by the British Retail Consortium (BRC), it was initially formulated for food producers supplying food to the UK. Subsequently, it has evolved into a global food safety standard widely used in food production and supply chain management worldwide. II. Scope of Application and Focus FSMA certification: Primarily targets food produced in the United States and imported into ...
- Source: drugdu
- 41
- March 28, 2025
【EXPERT Q&A】What are the implementation standards for DCS systems of pharmaceutical companies?

Drugdu.com expert’s response: DCS (Distributed Control System) is the core automation system in pharmaceutical manufacturing, requiring adherence to three critical objectives: compliance, data integrity, and system reliability. Below is a detailed breakdown based on international regulations, industry practices, and technical requirements: I. International Regulations & Industry Standards GMP Compliance FDA 21 CFR Part 11: Mandates electronic records and signatures, ensuring DCS data storage, modification, and audit trails meet regulatory standards. EU GMP Annex 11: Focuses on computerized system validation, including access control, data backup, and cybersecurity. ICH Q9/Q10: Risk-based quality systems requiring DCS to identify Critical Process Parameters (CPPs) and mitigate quality risks. GAMP 5 Guidelines: Classifies DCS as Category 4 (Configurable Software), requiring full lifecycle validation (URS, FAT, SAT, IQ/OQ/PQ). ISO Standards ISO 9001: Ensures quality management for DCS suppliers. ISO 27001: Protects DCS from cyber threats via information security protocols. II. Technical & Functional Requirements Data Integrity (ALCOA+ Principles) Traceability: Full operational ...
- Source: drugdu
- 59
- March 26, 2025
【EXPERT Q&A】How to do registration test and clinical evaluation for IVD reagents with different sampling methods?

Drugdu.com expert’s response: For IVD reagents with different sampling methods, their registration inspection and clinical evaluation need to follow certain procedures and standards to ensure product safety and effectiveness. Below is a detailed breakdown of this process: I. Registration Inspection 1.Selection of Representative Specifications for Inspection: According to the Measures for the Registration of In Vitro Diagnostic Reagents, if a registration application includes different packaging specifications (such as different sampling methods), one representative specification can be selected for inspection. The selected specification should cover the key performance parameters of all sampling methods, such as the limit of detection (LoD) and precision. 2. Performance Verification Items: Key Parameter Verification: This includes accuracy, precision (repeatability/reproducibility), LoD, limit of quantitation (LoQ), linear range, matrix effect, cross-reactivity, etc. Sampling Method Specificity Verification: Testing should be conducted separately for different sampling methods (e.g., manual/automatic, different sampling volumes) to ensure consistency in results. Communication with Inspection Agencies: ...
- Source: drugdu
- 51
- March 24, 2025
【EXPERT Q&A】What is the evaluation basis of the second type of medical device clinical trial verification?

Drugdu.com expert’s response: The evaluation basis for the clinical trial inspection of Class II medical devices mainly includes the following aspects: I. Regulatory Level Regulations on the Supervision and Administration of Medical Devices: As the basic regulation for the supervision of medical devices, this regulation stipulates the principles and requirements for the management of medical device clinical trials, serving as a crucial basis for clinical trial inspections. Measures for the Registration and Filing of Medical Devices: It clarifies the procedures, requirements, and conditions for the registration and filing of medical devices, providing a basis for the registration-related matters involved in clinical trial inspections. Measures for the Registration and Filing of In Vitro Diagnostic Reagents: This regulation standardizes the registration and filing of in vitro diagnostic reagents and serves as an important basis for the clinical trial inspection of Class II medical devices that are in vitro diagnostic reagents. Quality Management ...
- Source: drugdu
- 44
- March 21, 2025
【EXPERT Q&A】Why Class II and Class III medical devices should be registered?

Drugdu.com expert’s response: The registration of Class II and Class III medical devices is primarily based on the following reasons: I. Legal and Regulatory Requirements The “Regulations on the Supervision and Administration of Medical Devices” clearly stipulate that Class II and Class III medical devices must undergo registration management, and medical devices that have not undergone registration are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, and enterprises must comply with it to ensure legal operations. II. Risk Level Management Medical devices are classified into three categories based on their risk levels, with Class II and Class III belonging to medium and high-risk levels, respectively. Class II medical devices, such as thermometers, sphygmomanometers, and electrocardiographs, may lead to misdiagnosis, mistreatment, or cause certain harm to patients if there are issues with their quality or safety. ...
- Source: drugdu
- 47
- March 19, 2025
【EXPERT Q&A】What are the special environmental and facility requirements for the self-testing laboratory of IVD products?

Drugdu.com expert’s response: The self-testing laboratories for IVD (In Vitro Diagnostic) products have a series of specific requirements in terms of environment and facilities, which aim to ensure the safety, accuracy, and compliance of the laboratories. Below is a detailed summary of these requirements: I. Environmental Requirements Cleanliness: The cleanliness of the laboratory must meet the ISO 14644-1 standard, typically ISO 7 or ISO 8 class, to reduce particulate and microbial contamination. This helps ensure the accuracy and reliability of experimental results. Temperature and Humidity Control: The temperature is generally controlled between 20-25°C, and humidity between 30%-60%. Stable temperature and humidity conditions contribute to the normal operation of experimental equipment and the stability of experimental results. Biosafety: Depending on the type of experiments, the laboratory must comply with BSL-1 or BSL-2 (Biosafety Level Laboratory) standards. This includes setting up biosafety cabinets, installing HEPA filters, and other measures to prevent contamination ...
- Source: drugdu
- 59
- March 17, 2025
【EXPERT Q&A】How does Ibrutinib work?

Drugdu.com expert’s response: Ibrutinib demonstrates remarkable therapeutic efficacy, particularly in the treatment of various hematological malignancies. Below is a detailed analysis of its therapeutic effects: I. Primary Effects and Functions Inhibition of Malignant B-Cell Proliferation and Survival: Ibrutinib, as an inhibitor of Bruton’s tyrosine kinase (BTK), effectively inhibits BTK enzymatic activity by forming a covalent bond with the cysteine residue at the BTK active site, thereby blocking growth and survival signals in tumor cells. Reduction in B-Cell Migration and Adhesion In Vitro: By inhibiting BTK-mediated signaling pathways, ibrutinib further weakens the ability of malignant B-cells to spread and invade within the body, aiding in controlling disease progression. Improvement in Patient Prognosis and Quality of Life: For patients who have failed one or more lines of prior therapy, ibrutinib offers a new treatment option and extends patient survival. Additionally, it significantly improves patient symptoms, such as lymphadenopathy and fatigue, thereby enhancing ...
- Source: drugdu
- 58
- March 14, 2025

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