A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis in Mexican Adults

Establish the efficacy of combined treatment with nepafenac and lubricant versus lubricant alone in improving epiphora and resolving punctal stenosis in Mexican adults.

开始日期2026-01-12

申办/合作机构

Instituto de Oftalmología Fundación Conde de Valenciana

ChiCTR2500110461

/ SuspendedN/AIIT

Effect of Topical NSAIDs on Pain Management During Intravitreal Injections

开始日期2025-10-17

申办/合作机构-

CTRI/2025/09/094432

/ Not yet recruiting临床4期IIT

Comparative efficacy of Nepafenac 0.3 percent once daily versus Nepafenac 0.1 percent thrice daily eyedrops in preventing macular edema following pan retinal photocoagulation in diabetic retinopathy. - NIL

开始日期2025-09-19

申办/合作机构-

100 项与奈帕芬胺相关的临床结果

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100 项与奈帕芬胺相关的转化医学

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100 项与奈帕芬胺相关的专利（医药）

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331

项与奈帕芬胺相关的文献（医药）

2026-05-01·Veterinary Medicine and Science

Effects of Topical Steroids and Non‐Steroidal Anti‐Inflammatory Drugs on Gastrointestinal Bleeding in Rats

Article

作者: Ozlem Ozmen ; Aybike Ozbeyli ; Harun Cinar ; Beyza Bektas ; Latif Emrah Yanmaz

ABSTRACT:

Objective:

This study aimed to investigate the potential systemic gastrointestinal (GI) effects of short‐term topical administration of ocular steroids and non‐steroidal anti‐inflammatory drugs (NSAIDs) in rats.

Animals:

A total of 56 adult male Wistar rats were assigned to seven treatment groups ( n = 8 for each group), receiving topical applications of saline, prednisolone acetate, dexamethasone phosphate, loteprednol etabonate, ketorolac tromethamine, nepafenac or diclofenac sodium for 1 week.

Methods:

GI bleeding was assessed using faecal occult blood tests, gastric and duodenal tissues were analysed histopathologically, and endoscopic evaluations were performed.

Results:

Positive faecal occult blood results were observed in the prednisolone acetate group (3/8; 37.5%), dexamethasone phosphate (2/8; 25%), diclofenac sodium (1/8; 12.5%) and loteprednol etabonate (1/8; 12.5%). No positive results were recorded in the ketorolac tromethamine, nepafenac, or saline groups (0%). Differences between groups were not statistically significant ( p > 0.05). No significant within‐group differences between baseline and post‐treatment results were detected ( p > 0.05). Endoscopic scores ranged from 0 to 1 across all groups, and histopathology revealed no abnormalities.

Conclusions and clinical relevance:

Short‐term topical ocular steroid and NSAID treatments were not associated with statistically significant systemic gastrointestinal alterations under the conditions of this study.

2026-04-01·MATURITAS

Effect of a non-hormonal vaginal moisturizer on vaginal and vulvar health in postmenopausal women with breast cancer: A randomized clinical trial

Article

作者: Carvalho-Pessoa, Eduardo ; Nahas, Georgia Petri ; VItorino, Caroline Nakano ; Martin, Barbara Campos ; Souza, Rafaela ; Medolago, Natalia ; Nahas, Eliana Aguiar Petri ; Vespoli, Heloisa De Luca

OBJECTIVE:

To evaluate the effectiveness of non-hormonal vaginal moisturizer on vaginal and vulvar health in postmenopausal women with breast cancer.

STUDY DESIGN:

A randomized, open-label trial was conducted in women aged 45-65 years with breast cancer (stages I-III) who had completed oncological treatment (excluding endocrine therapy) and reported vaginal symptoms (vaginal dryness and/or dyspareunia). Participants were randomized into two groups: one group used a vaginal moisturizer (three times per week, at night, n = 50) and the other a vaginal lubricant (during sexual intercourse, n = 50). The 16-week intervention included assessments at baseline, 8, and 16 weeks.

MAIN OUTCOME MEASURES:

Vaginal and vulvar health were assessed using the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Vaginal Health Index (VHI), vaginal pH, and Vaginal Maturation Index (VMI). The primary outcome was improvement in vaginal health as measured by the VHI.

RESULTS:

Of the 100 randomized women, 12 discontinued the study (4 in the moisturizer group and 8 in the lubricant group). Adherence to the moisturizer was high (85.9%) and no serious adverse events were reported. At 8 and 16 weeks, the moisturizer group showed significant improvement in VAS (p = 0.014) and VuAS (p = 0.003) scores, as well as a significant increase in VHI scores, indicating improvements in elasticity, moisture, fluid volume, epithelial integrity, and pH (p < 0.0001) compared with the control group. Vaginal pH significantly decreased in the moisturizer group compared with the control group (p = 0.016). No significant between-group differences were observed in VMI scores after 16 weeks (p = 0.213).

CONCLUSIONS:

The non-hormonal vaginal moisturizer was effective in improving vaginal and vulvar health parameters in postmenopausal women with breast cancer compared with a vaginal lubricant. Brazilian Clinical Trials Registry (ReBEC,) number RBR-5cf7vzj.

2026-03-04·DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Novel stable micellar formulation for ocular delivery of nepafenac: optimization, characterization and in-vitro evaluation

Article

作者: Sorathia, Kishorkumar ; Vashi, Ronak

OBJECTIVE:

The objective of this study was to develop a stable clear ophthalmic nano-micellar formulation of Nepafenac.

SIGNIFICANCE:

The current marketed suspension formulation of nepafenac indicated for post-surgical uveitis is associated with higher manufacturing complexity and cost due to the need for sterile drug substance and specialized aseptic processing inherent to suspension-based ophthalmic products. It also exhibits limitations in patient compliance due to relatively high viscosity, lacrimation, and foreign body sensation following instillation.

METHODS:

Pre-formulation study was done to identify the excipients required. Systematic changes in the concentration of surfactant and crystal inhibitor along with other excipients led to the development of stable nano-micellar formulation. Box-behnken method was used for the optimization. The optimized micellar composition was evaluated for physicochemical tests particle size, zeta potential, cloud point, osmolality pH, assay of drug, entrapment efficiency and dynamic viscosity. Further in-vitro cell viability, in-vitro release, ocular tolerance test and stability evaluation were also performed.

RESULTS:

Average particle size of the micelle ranged from 10 to 20 nm, 43.5 mPas dynamic viscosity, osmolality of 319 mOsm/Kg, pH 7.4 and cloud point of 59.7 °C. The optimized formulation demonstrated in-vitro safety as confirmed by MTT cell viability and HET-CAM ocular irritation assays, and exhibited physicochemical stability for up to 6 months under real-time storage conditions.

CONCLUSION:

The optimized micelle formulation can serve as a better alternative for ophthalmic delivery of nepafenac.

项与奈帕芬胺相关的新闻（医药）

2026-03-18

·GlobeNewswire-Health Care

Harrow Announces Three Abstracts Accepted for Presentation at ASCRS 2026 Annual Meeting

NASHVILLE, Tenn., March 18, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that three scientific abstracts highlighting its commercial products VEVYE® (cyclosporine ophthalmic solution) 0.1% and ILEVRO® (nepafenac ophthalmic suspension) 0.3% have been accepted for presentation at the American Society of Cataract and Refractive Surgery (ASCRS) 2026 Annual Meeting, taking place April 10–13 at the Walter E. Washington Convention Center in Washington, D.C. The accepted research underscores Harrow’s continued commitment to advancing evidence-based treatment options for ophthalmic diseases, including dry eye disease and post-cataract surgery complications. The abstracts will be presented in the following scientific sessions: Ocular Surface DiseaseDate: Saturday¸ April 11, 2026Time: 8:00 AM – 9:30 AM VEVYE: Real-World Treatment Patterns and Clinical Outcomes with Cyclosporine 0.1% in Semifluorinated Alkane for Dry Eye Disease Presenter: A. Epitropoulos, MD VEVYE: Dual-Function Cyclosporine 0.1% in Perfluorobutylpentane as an Alternative to Corticosteroids in Post-Fungal Keratoplasty Presenter: T. Shoshany, MD Medications (Preoperative, Postoperative, Intraoperative)Date: Sunday, April 12, 2026Time: 8:00 AM – 9:30 AM ILEVRO: Post-Hoc Analysis of the Effect of Nepafenac 0.3% on Reducing Clinically Significant Visual Acuity Loss Associated with Cataract Surgery in subjects with Macular Edema Presenter: I. Mac, MD The ASCRS Annual Meeting is one of the world’s premier gatherings for ophthalmic surgeons and ophthalmic professionals, showcasing the latest clinical research, surgical techniques, and therapeutic innovations in ophthalmology. Additional details regarding the abstracts and supporting data will be available at the time of presentation. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and retina diseases. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts:Mike BiegaVice President of Investor Relations and Communications mbiega@harrowinc.com617-913-8890

2026-03-12

·谷穗随想

药学专业英语单词表03

- 差点忘了这茬了，从今天开始坚持。 - 今天Protect the nuts老师特愤恨地对着面对英文屁都放不出来的我们说，学点专业英语吧，:) LIST 1 Pharmaceutics biopharmaceutics classification system，BCS，生物药剂学分类系统 permeability，/pəˈmeeəbɪləti/，渗透性 Solubility，/səˈljuːbɪləti/，溶解度 Immediate Release，/ɪˈmiːdiət reɪˈliːs/，速释制剂 Pharmaceutics，/fəˈmæsjuːtɪks/，药剂学 Active Pharmaceutical Ingredient (API)，/ækˈtɪv faʊˈmæsjuːtɪkəl ˈɪŋrɪdiənt/，活性药物成分 excipients，/ɪkˈsɪpiənts/，辅料 coenzyme，/ˈkoʊɛnzaɪm/，辅酶 prosthetic group，/ˈprɒstθetɪk ɡruːp/，辅基 enteric coating，/ɛnˈtɛrɪk koʊtɪŋ/，肠溶衣 sustained-release tablet，/səˈsteɪnd rɪˈliːs tæblət/，缓释片 controlled release preparation，控释制剂 targeted drug delivery，靶向给药 prolonged action preparation，/prəˈlɔːŋd /，缓释制剂 film-coating，/ˈfɪlm koʊtɪŋ/，薄膜衣 coated tablet，/koʊtɪd ˈtæblət/，包衣片 solid dispersion，/ˈsɑːlɪd dɪˈspɜːrʒən/，固体分散体 liposome，/ˈlɪpsəsəʊm/，脂质体 microsphere，/ˈmaɪkrəsfiər/，微球 nanoparticle，/ˈnænəʊpɑːrtɪkl/，纳米粒 emulsion，/ɪˈmʌlʒən/，乳剂 suspension，/səˈspenʃn/，混悬剂 solution，/səˈluːʃn/，溶液剂 suppository，/ˈsuːpjəstəri/，栓剂 inhalation，/ɪnˈhæleɪʃn/，吸入剂 transdermal patch，/ˈtrænzdɜːrməl pætʃ/，透皮贴剂 implant，/ɪmˈplænt/，植入剂 sterile preparation，/ˈstɛrəl prɪˈpeəreɪʃn/，无菌制剂 lyophilized formulation，/ˌlaɪəˈfɪləaɪzd /，冻干制剂 buffer solution，/ˈbʌfər səˈluːʃn/，缓冲液， cosolvent，/ˈkəʊzɒlvənt/，助溶剂 complexation，/kəmˈpleksʃən/，络合作用 polymorphism，/pəˈlɪmɔːfɪzəm/，多晶型现象 crystal form，/ˈkrɪstəl fɔːrm/，晶型 particle size，/ˈpɑːrtɪkl saɪz/，粒径 surface tension，/ˈsɜːrfɪs tɛnʒən/，表面张力 viscosity，/vɪˈskɒsəti/，黏度 rheology，/riˈɒlədʒi/，流变学 osmotic pressure，/ɒzˈmɒtɪk ˈpreʃər/，渗透压 disintegration time，/ˌdɪsɪnˈtɪɡreɪʃn taɪm/，崩解时限 dissolution rate，/daɪˈsɒlvjuːʃn reɪt/，溶出速率 bioavailability，/baɪˈoʊəvələbələti/，生物利用度 therapeutic index，/θerəˈpjuːtɪk ɪndeks/，治疗指数 therapeutic window，/θerəˈpjuːtɪk ˈwɪndəʊ/。治疗窗 pharmacokinetics，/fɑːməˈkɒnətɪks/，药物动力学 pharmacodynamics，/fɑːməˈkɒnədɪnæmɪks/，药物效应动力学 toxicokinetics，/tɒkˈsɪkəkɪnɪtɪks/，毒物动力学 steady-state concentration，/ˈstiːdi staɪt /，稳态血药浓度 loading dose，/ˈləʊdɪŋ doʊs/，负荷剂量 maintenance dose，/ˈmeɪntənəns doʊs/，维持剂量 cumulative dose，/ˈkjuːmjələtɪv doʊs/，累积剂量 dose-response relationship，/ˈdoʊs rɪˈspɒns rɪˈleɪʃnʃɪp/，量效关系 therapeutic equivalence，/θerəˈpjuːtɪk ɪˈkwɪvələnsi/，治疗等效性 pharmaceutical excipient，/fəˈmæsjuːtɪkəl ɪkˈsɪpiənt/，药用辅料 preservative，/prɪˈzɜːrvətɪv/，防腐剂 stabilizer，/ˈsteɪbəlaɪzər/，稳定剂 humectant，/ˈhjuːməktənt/，保湿剂 chelating agent，/ˈkiːleɪtɪŋ eɪdʒənt/，螯合剂 buffering agent，/ˈbʌfərɪŋ eɪdʒənt/，缓冲剂 solubilizer，/ˈsɒljəbaɪləraɪzər/，增溶剂 osmotic agent，/ɒzˈmɒtɪk eɪdʒənt/，渗透压调节剂 colorant，/ˈkʌlərənt/，着色剂 flavoring agent，/ˈfleɪvərɪŋ eɪdʒənt/，矫味剂 sweetener，/ˈswiːtnər/，甜味剂 disintegrant，/dɪsˈɪntɪɡreɪnt/，崩解剂 lubricant，/ˈluːbrɪkənt/，润滑剂 glidant，/ˈɡlaɪdənt/，助流剂 antiadherent，/ænˈtaɪədɪhərənt/，抗黏剂 matrix former，/ˈmeɪtrɪks fɔːrmər/，骨架材料 rate-controlling membrane，/ˈreɪt kənˈtrəʊlɪŋ meɪbrən/，控释膜 diffusion layer，/ˈdɪfjuːʒən leɪər/，扩散层 reservoir system，/ˈrezəvwɑːr sɪˈstem/，储库型系统 osmotic pump，/ˈɒzmɒtɪk pʌmp/，渗透泵 ion-exchange resin，/ˈaɪən ɪksˈtʃeɪndʒ ˈrezɪn/，离子交换树脂 molecular encapsulation，/ˈmɒlɪkjuːlər ɪnˈkæpsjuleɪʃn/，分子包囊 nanotechnology，/ˈnænəʊtɛkˈnɒlədʒi/，纳米技术 microencapsulation，/ˌmaɪkrəʊˈɛnkæpsjuleɪʃn/，微囊化 liposomal formulation，/ˈlɪpsəsəʊməl /，脂质体制剂 polymeric micelle，/ˌpɒlɪmərɪk ˈmaɪsəl/，聚合物胶束 cyclodextrin，/ˈsaɪkləʊdekstrɪn/，环糊精 self-emulsifying drug delivery system (SEDDS)/ ɪˈmʌlsɪfaɪɪŋ /，自乳化释药系统 nanocrystal，/ˈnænəʊkrɪstəl/，纳米结晶 amorphous solid dispersion，/əˈmɔːfəs sɒlɪd dɪˈspɜːrʒən/，无定形固体分散体 hot-melt extrusion，/ˈhɒt melt ɪkˈstruːʒən/，热熔挤出 electrospinning，/ɪˈlektrəʊspɪnɪŋ/，静电纺丝 3D printing，/ˈθriːdi ˈprɪntɪŋ/，3D打印（药物制剂） quality by design (QbD)，/ˈkwɒləti baɪ dɪˈzaɪn/，质量源于设计 critical quality attribute (CQA)，关键质量属性 process analytical technology (PAT)，过程分析技术 design space，设计空间 real-time release testing (RTRT)，实时放行检测 continuous manufacturing，/ˌkɒntɪˈnuəs mænjuˈfæktʃərɪŋ/，连续制造 patent ductus arteriosus (PDA)，/ˈpeɪtənt dʌk.təs ɑːrˈtɪri.oʊ.saɪtɪs/，动脉导管未闭各国药典中国药典 Chinese Pharmacopoeia 缩写：Ch.P. 美国药典 United States Pharmacopeia 缩写：USP-NF（含《国家处方集》National Formulary）欧洲药典 European Pharmacopoeia 缩写：Ph.Eur. 或 EP 日本药局方 Japanese Pharmacopoeia 缩写：JP 英国药典 British Pharmacopoeia 缩写：BP 印度药典 Indian Pharmacopoeia 缩写：IP 国际药典 International Pharmacopoeia 缩写：Ph.Int.（避免与印度药典缩写混淆）澳大利亚药典 Australian Pharmacopoeia 缩写：AP 加拿大药典 Canadian Pharmacopoeia 缩写：CPhA 或 HPB（Health Canada出版）巴西药典 Brazilian Pharmacopoeia 缩写：Farmacopeia Brasileira 或 FB 世界卫生组织药典 WHO Pharmacopoeia 缩写：WHO-P 常见剂型与给药途径术语 API Active Pharmaceutical Ingredient 活性药物成分（原料药） Capsule 胶囊剂 Cream 乳膏剂 Dispersible Tablet 分散片 Dry Powder Inhaler (DPI) 干粉吸入剂 Emulsion 乳剂 Extended-Release (ER) 缓释制剂 Gel 凝胶剂 Granule 颗粒剂 Implant 植入剂 Intramuscular Injection (IM) 肌内注射剂 Intravenous Injection (IV) 静脉注射剂 Lotion 溶液剂（洗剂） Lozenge 含片 Microsphere 微球 Nanoparticle 纳米粒 Ointment 软膏剂 Oral Solution 口服溶液 Ophthalmic Solution 滴眼剂 Parenteral Preparation 注射剂（非肠道给药） Patch 经皮贴剂 Pellet 微丸 Powder 散剂 Rectal Suppository 直肠栓剂 Sustained-Release (SR) 缓释制剂 Suspension 混悬剂 Tablet 片剂（Tab为其缩写） Transdermal System (TDS) 透皮给药系统 Vaginal Suppository 阴道栓剂 Viscous Liquid 黏稠液体给药系统缩写 CS：Controlled System（控释系统） DDS：Drug Delivery System（药物递送系统） ER：Extended Release（缓释） IR：Immediate Release（速释）缩写 CR Controlled Release 控释制剂（通过特殊膜或骨架控制药物释放速率） DR Delayed Release 迟释制剂（药物在特定时间或pH条件下释放，如肠溶胶囊） EC Enteric Coated 肠溶包衣（在胃酸中不溶解，肠道中释放） IR Immediate Release 速释制剂（药物快速释放，如普通片剂） LA Long-Acting 长效制剂（单次给药后作用时间延长） MR Modified Release 改良释放（广义缓释/控释的统称） ODT Orally Disintegrating Tablet 口崩片（口腔内迅速崩解，无需饮水） PA Pulsatile Release 脉冲式释药（按预设时间分次释放药物） PR Prolonged Release 延长释放（与缓释类似，但更强调持续时间） SL Sublingual 舌下给药（药物通过舌下黏膜快速吸收） SR Sustained Release 持续释放（药物缓慢均匀释放，维持血药浓度） TD Transdermal 经皮给药（通过皮肤吸收，如贴剂） TDDS Transdermal Drug Delivery System 透皮给药系统（如尼古丁贴片） UPA Ultra Rapid Acting 超速效制剂（如超短效胰岛素）药物稳定性相关术语 Photostability 光稳定性（药物抵抗光照降解的能力） Thermal Stability 热稳定性（药物在高温下的化学稳定性） Hygroscopicity 吸湿性（药物吸收水分的倾向） Oxidative Degradation 氧化降解（药物因氧化反应失效的过程） LIST 2 Pharmacoeconomics 1. Cost-Benefit Analysis (CBA) /kɒstˈbɛnɪfɪt əˈnæləsɪs/ 成本效益分析评估医疗干预措施的经济价值，比较总成本与总效益（通常以货币单位衡量）。 2. Cost-Effectiveness Analysis (CEA) /kɒst ɪˈfektɪvnəs əˈnæləsɪs/ 成本效果分析比较不同干预措施的成本与其产生的健康效果（如治愈率、生存期），通常以成本/效果单位表示（如¥/QALY）。 3. Cost-Utility Analysis (CUA) /kɒst ˈjuːtɪləti əˈnæləsɪs/ 成本效用分析评估干预措施的性价比，使用质量调整生命年（QALY）或伤残调整生命年（DALY）作为效果指标。 4. Incremental Cost-Effectiveness Ratio (ICER) /ˌɪŋkrəˈmentl kɒst ɪˈfektɪvnəs riˈʃɪəʊ/ 增量成本效果比新增单位健康效果所需额外成本，公式：(C1-C0)/(E1-E0)，常用于卫生政策决策。 5. Budget Impact Analysis (BIA) ˈbʌdʒɪt ɪmˈpækt əˈnæləsɪs/ 预算影响分析评估新药或治疗纳入医保后对卫生系统预算的短期财务影响。 6. Quality-Adjusted Life Year (QALY) /ˈkwɒləti əˈdʒʌstɪd laɪf jɪə(r)/ 质量调整生命年综合生命长度和生活质量的综合指标，1 QALY = 完全健康生存1年。 7. Health Technology Assessment (HTA) /ˈhɛlθ tɛknələʤi əˈsɛsmənt/ 卫生技术评估对医疗技术（药物、器械、疗法）的安全性、有效性、经济性的系统性评价。 8. Pharmacoeconomics /fɑːməˈkɒnəmɪks/ 药物经济学应用经济学原理评估药物治疗的成本、效果和效益的学科。 9. Markov Model /ˈmɑːkɒv mɒdl/ 马尔可夫模型用于模拟疾病进展和干预效果的数学模型，假设状态转移概率固定。 10. Discrete Event Simulation (DES) /dɪˈskriːt ɪˈvent sɪmjuˈleɪʃn/ 离散事件模拟通过模拟个体患者路径评估医疗策略的长期成本和效果。 11. Cost Minimization Analysis (CMA) /kɒst mɪˈnɪmɪˈzeɪʃn əˈnæləsɪs/ 成本最小化分析当干预效果相同时，比较不同方案的成本差异。 12. Willingness-to-Pay (WTP) /ˈwɪlɪŋnəs tuː ˈpeɪ/ 支付意愿患者或社会为获得某种健康效果愿意支付的最高金额。 13. Return on Investment (ROI) /rɪˈtɜːn ɒn ɪnˈvɛstmənt/ 投资回报率衡量医疗干预的经济回报，公式：（收益 - 成本）/ 成本 × 100%。 14. Incremental Net Benefit (INB) /ˈɪŋkrəməntl nɛt bɛˈnɛfɪt/ 增量净效益 ICER的另一种表达，公式：(ΔE × λ) - ΔC，λ为支付意愿阈值。 15. Health-Related Quality of Life (HRQoL) /ˈhɛlθ rɪˈleɪtɪd kwaˈlɪti ɒv laɪf/ 健康相关生活质量评估疾病和治疗对患者心理、生理和社会功能的影响。 Cost-Benefit Analysis (CBA) /kɒstˈbɛnɪfɪt əˈnæləsɪs/ 成本效益分析 Cost-Effectiveness Analysis (CEA) /kɒst ɪˈfektɪvnəs əˈnæləsɪs/ 成本效果分析 Cost-Utility Analysis (CUA) /kɒst ˈjuːtɪləti əˈnæləsɪs/ 成本效用分析 Incremental Cost-Effectiveness Ratio (ICER) /ˌɪŋkrəˈmentl kɒst ɪˈfektɪvnəs riˈʃɪəʊ/ 增量成本效果比 Budget Impact Analysis (BIA) /ˈbʌdʒɪt ɪmˈpækt əˈnæləsɪs/ 预算影响分析 Quality-Adjusted Life Year (QALY) /ˈkwɒləti əˈdʒʌstɪd laɪf jɪə(r)/ 质量调整生命年 Health Technology Assessment (HTA) /ˈhɛlθ tɛknələʤi əˈsɛsmənt/ 卫生技术评估 Pharmacoeconomics /fɑːməˈkɒnəmɪks/ 药物经济学 Markov Model /ˈmɑːkɒv mɒdl/ 马尔可夫模型 Discrete Event Simulation (DES) /dɪˈskriːt ɪˈvent sɪmjuˈleɪʃn/ 离散事件模拟 Cost Minimization Analysis (CMA) /kɒst mɪˈnɪmɪˈzeɪʃn əˈnæləsɪs/ 成本最小化分析 Willingness-to-Pay (WTP) /ˈwɪlɪŋnəs tuː ˈpeɪ/ 支付意愿 Return on Investment (ROI) /ˈrɪˈtɜːn ɒn ɪnˈvɛstmənt/ 投资回报率 Incremental Net Benefit (INB) /ˈɪŋkrəməntl nɛt bɛˈnɛfɪt/ 增量净效益 Health-Related Quality of Life (HRQoL) /ˈhɛlθ rɪˈleɪtɪd kwaˈlɪti ɒv laɪf/ 健康相关生活质量 Value-Based Pricing (VBP) /ˈvæljuː bæst ˈpraɪsɪŋ/ 基于价值的定价 Real-World Evidence (RWE) /ˈriːəl wɜːld ˈɛvɪdəns/ 真实世界证据 Cost-Sharing /ˈkɒst ʃɛrɪŋ/ 费用分担 Patient Access Scheme (PAS) /ˈpeɪʃnt ˈækses skiːm/ 患者准入计划 Health Equity /ˈhɛlθ ˈɛkwəti/ 卫生公平性 Comparative Effectiveness Research (CER) /kəmˈpærətɪv ɪˈfektɪvnəs rɪˈsɜːtʃ/ 比较效果研究 Economic Evaluation /ˌiːkəˈnɒmɪk ɪˈvæljʊˈeɪʃn/ 经济学评价 Health Outcome /ˈhɛlθ ˈaʊtkʌm/ 健康结局 Resource Allocation /ˈriːsɔːrs əˈlɒkəˈeɪʃn/ 资源分配 Decision-Analytic Model /dɪˈsɪʒn əˈnælɪtɪk mɒdl/ 决策分析模型 Sensitivity Analysis /sənˈsɪtɪvəti əˈnæləsɪs/ 敏感性分析 Threshold Analysis /ˈθrɛʃhəʊld əˈnæləsɪs/ 阈值分析 Cost of Illness /kɒst ɒv ˈɪlnəs/ 疾病成本 Health Policy /ˈhɛlθ pɒləsi/ 卫生政策 Reimbursement Mechanism /ˌriːɪmˈbɜːsmənt ˈmekənɪzəm/ 报销机制 LIST 3 Clinical pharmacology Solubility, /səˈljuːbɪləti/, 溶解度 Bioavailability, /ˌbaɪoəˈveɪləbɪləti/, 生物利用度 Pharmacokinetics, /fɑːməˈkɪnɪtɪks/, 药代动力学 Pharmacodynamics, /faːməˈkɒdʌmɪks/, 药效学 Therapeutic Index, 治疗指数 Adverse Drug Reaction (ADR), 药物不良反应 Clinical Trial, 临床试验 Efficacy, /ˈɛfɪkəsi/, 疗效 Toxicity, /tɒkˈsɪsəti/, 毒性 Dose-Response Relationship, 剂量-反应关系 Half-Life, 半衰期 Bioequivalence, /ˌbaɪoˈɛkwɪvələns/, 生物等效性 Placebo-Controlled, 安慰剂对照 Randomized Controlled Trial (RCT), 随机对照试验 Pharmacogenomics, /ˌfɑːməˈkəʊdʒənəʊmɪks/, 药物基因组学 Pharmacotherapy, /fɑːməˈkɒθərəpi/, 药物治疗学 Chronic Toxicity, 慢性毒性 Acute Toxicity, 急性毒性 Tolerability, /tɒləˈræbɪləti/, 耐受性 Pharmacovigilance, /ˌfɑːməˈkɒvɪdʒələns/, 药物警戒 Dosage Regimen, 给药方案 Therapeutic Drug Monitoring (TDM), 治疗药物监测 Pharmacokinetic Parameters, 药代动力学参数 Absorption Rate Constant, 吸收速率常数 Distribution Volume, 分布容积 Metabolite, /ˈmɛtəbaɪt/, 代谢产物 Excretion, /ɪkˈskriːʃən/, 排泄 Prodrug, /ˈprəʊdrʌɡ/, 前体药物 Synergistic Effect, 协同作用 Antagonistic Interaction, 拮抗作用 Therapeutic Window, 治疗窗 Steady-State Concentration, 稳态血药浓度 Bioavailability Study, 生物利用度研究 Pharmacodynamic Interaction, 药效学相互作用 Pharmacodynamics /fɑːrməˈkɑːdənæmɪks/，药物动力学 Therapeutic Index /θerəˈpjuːtɪk ɪndeks/，治疗指数 Bioavailability /baɪoʊˈævələbɪləti/，生物利用度 Therapeutic Equivalence /θerəˈpjuːtɪk iˈkwɪvələnsi/，治疗等效性 Dose-Response Relationship /dəʊs rɪˈspɒns rɪˈleɪʃnʃɪp/，剂量-反应关系 Adverse Drug Reaction /ædvɜːrs druːɡ riˈækʃn/，药物不良反应 Drug Interaction /drʌɡ ɪntərˈækʃn/，药物相互作用 Therapeutic Drug Monitoring /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ/，治疗药物监测 Clinical Trial /ˈklɪnɪkəl traɪəl/，临床试验 Efficacy /ˈefɪkəsi/，疗效 Safety Profile /ˈseɪfti prəʊfaɪl/，安全性特征 Posology /pəˈsɒlədʒi/，剂量学 Pharmacogenomics /ˌfɑːrməˈkɒdʒənəʊmɪks/，药物基因组学 Pharmacokinetics /fɑːrməˈkɒkɪnətɪks/，药物代谢动力学 Rational Drug Use /ˈræʃnəl drʌɡ juːz/，合理用药 Therapeutic Range /θerəˈpjuːtɪk reɪndʒ/，治疗窗 Compliance /kəmˈplaɪəns/，依从性 Risk-Benefit Assessment /ˈrɪskˈbenɪfɪt əˈsesmənt/，风险-效益评估 Pharmacovigilance /ˌfɑːrməˈkɒvɪdʒələns/，药物警戒 Dosing Regimen /ˈdoʊsɪŋ ˈredʒɪmen/，给药方案 Pharmacotherapeutics /ˌfɑːrməˈkɒθərəpjuːtɪks/，药物疗法 Toxicokinetics /tɒksɪˈkɒnətɪks/，毒物代谢动力学 Placebo Effect /ˈplɑːsiːboʊ ɪˈfekt/，安慰剂效应 Chronotherapy /krəˈnɒθərəpi/，时间治疗学 Formulation Development /fɔːrˈmeɪləʃn dɪˈveləpmənt/，制剂开发 Biopharmaceutics /ˌbaɪoʊˈfɑːrməsjuːtɪks/，生物药剂学 Steady-State Concentration /ˈstiːdi staɪt kənˈsentrˈeɪʃn/，稳态血药浓度 Prodrug Design /prəʊˈdrʌɡ dɪˈzaɪn/，前药设计 Therapeutic Drug Level /θerəˈpjuːtɪk drʌɡ lɛvəl/，治疗药物水平 Population Pharmacokinetics /ˌpɒpjʊˈleɪʃn fɑːrməˈkɒkɪnətɪks/，群体药代动力学 PK/PD Modeling /pk pd ˈmɒdəlɪŋ/，药代-药效学建模 Therapeutic Failure /θerəˈpjuːtɪk feɪljər/，治疗失败 Drug Resistance /druːɡ rɪˈzɪstəns/，耐药性 Therapeutic Window /θerəˈpjuːtɪk wɪndəʊ/，治疗窗口 Pharmacodynamic Interaction /fɑːrməkəʊˈdɪnæmɪk ɪntərˈækʃn/，药效学相互作用 Pharmacokinetic Interaction /fɑːrməˈkɒkɪnətɪk ɪntərˈækʃn/，药代动力学相互作用 Adverse Event Reporting System /ædvɜːrs ɪˈvent rɪˈpɔːrtɪŋ sɪstəm/，不良事件报告系统 Therapeutic Drug Information /θerəˈpjuːtɪk drʌɡ ɪnfərˈmeɪʃn/，治疗药物信息 Pharmacoeconomics /fɑːrməˈkɒnəmɪks/，药物经济学 Patient Counseling /ˈkaʊnsəlɪŋ/，患者用药指导 Therapeutic Drug Monitoring Program /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ prəˈɡræm/，治疗药物监测计划 Dose Optimization /doʊs ˈɒptɪmaɪˈzeɪʃn/，剂量优化 Therapeutic Misadventure /θerəˈpjuːtɪk mɪsˈædvenʧər/，治疗意外事件 Pharmacogenetics /fɑːrməˈkɒdʒənətɪks/，药物遗传学 Pharmacotherapy /fɑːrməˈkɒθərəpi/，药物治疗学 Toxicity Threshold /ˈtɒksɪsəti ˈθreʃhəʊld/，毒性阈值 Pharmacometrics /fɑːrməˈkɒmɪtrɪks/，药物计量学 Therapeutic Alliance /θerəˈpjuːtɪk əˈlaɪəns/，治疗同盟 Pharmacovigilance System /ˌfɑːrməˈkɒvɪdʒələns sɪstəm/，药物警戒系统 Dose Escalation /doʊs ɛˈskæləʃən/，剂量递增 Therapeutic Drug Level Monitoring /θerəˈpjuːtɪk drʌɡ lɛvəl ˈmɒnɪtərɪŋ/，治疗药物水平监测 Pharmacogenomic Testing /fɑːrməˈkɒdʒənəʊmɪk ˈtestɪŋ/，药物基因组学检测 Pharmacodynamic Effect /fɑːrməkəʊˈdɪnæmɪk ɪˈfekt/，药效学效应 Pharmacokinetic Parameter /fɑːrməˈkɒkɪnətɪk pəˈræmɪtər/，药代动力学参数 Therapeutic Drug Misuse /θerəˈpjuːtɪk drʌɡ mɪsˈjuːz/，治疗药物误用 Pharmacogenetic Testing /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ/，药物遗传学检测 Pharmacokinetic Study /fɑːrməˈkɒkɪnətɪk stʌdɪ/，药代动力学研究 Therapeutic Effectiveness /θerəˈpjuːtɪk ɪˈfektɪvnəs/，治疗效果 Pharmacodynamic Interaction Study /fɑːrməkəʊˈdɪnæmɪk ɪntərˈækʃn stʌdɪ/，药效学相互作用研究 Pharmacokinetic-Pharmacodynamic Modeling /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈmɒdəlɪŋ/，药代-药效学建模 Therapeutic Drug Monitoring System /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ sɪstəm/，治疗药物监测系统 Pharmacogenetic Variant /fɑːrməˈkɒdʒənətɪk ˈvɛrɪənt/，药物遗传学变异 Pharmacokinetic Parameter Estimation /fɑːrməˈkɒkɪnətɪk pəˈræmɪtər ɛˈsteɪʃən/，药代动力学参数估计 Therapeutic Drug Misadministration /θerəˈpjuːtɪk drʌɡ mɪsədˈmɪnɪstreɪʃn/，治疗药物误用 Pharmacogenetic Testing Laboratory /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ læbərətɔːri/，药物遗传学检测实验室 Pharmacokinetic-Pharmacodynamic Correlation /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk kɔːˈrɛləˈeɪʃən/，药代-药效学相关性 Therapeutic Drug Monitoring Protocol /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ prəˈtəʊkɒl/，治疗药物监测方案 Pharmacogenetic Data Analysis /fɑːrməˈkɒdʒənətɪk ˈdeɪtə əˈnæləsɪs/，药物遗传学数据分析 Pharmacokinetic-Pharmacodynamic Simulation /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk sɪmjuˈleɪʃən/，药代-药效学模拟 Therapeutic Drug Monitoring Database /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈdeɪtəbeɪs/，治疗药物监测数据库 Pharmacogenetic Risk Assessment /fɑːrməˈkɒdʒənətɪk ˈrɪsk əˈsesmənt/，药物遗传学风险评估 Pharmacokinetic-Pharmacodynamic Relationship /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk rɪˈleɪʃnʃɪp/，药代-药效学关系 Therapeutic Drug Monitoring Software /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ sɒftweə/，治疗药物监测软件 Pharmacogenetic Test Result Interpretation /fɑːrməˈkɒdʒənətɪk tɛst rɪˈzʌlt ɪnˈtɜːprɪˈteɪʃən/，药物遗传学检测结果解读 Pharmacokinetic-Pharmacodynamic Threshold /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈθreʃhəʊld/，药代-药效学阈值 Therapeutic Drug Monitoring Training /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈtreɪnɪŋ/，治疗药物监测培训 Pharmacogenetic Variant Interpretation /fɑːrməˈkɒdʒənətɪk ˈvɛrɪənt ɪnˈtɜːprɪˈteɪʃən/，药物遗传学变异解读 Pharmacokinetic-Pharmacodynamic Validation /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk vælɪˈdeɪʃən/，药代-药效学验证 Therapeutic Drug Monitoring Workflow /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈwɜːkfloʊ/，治疗药物监测工作流程 Pharmacogenetic Testing Coverage /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˈkʌvərɪdʒ/，药物遗传学检测覆盖范围 Pharmacokinetic-Pharmacodynamic Coupling /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈkuːplɪŋ/，药代-药效学耦合 Therapeutic Drug Monitoring Quality Control /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈkwɒlɪtəkənˈtrəʊl/，治疗药物监测质量控制 Pharmacogenetic Test Utilization /fɑːrməˈkɒdʒənətɪk tɛst juːˈtɪlɪˈzeɪʃən/，药物遗传学检测利用 Pharmacokinetic-Pharmacodynamic Sensitivity /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈsensəˈtɪvəti/，药代-药效学敏感性 Therapeutic Drug Monitoring Education /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ɛˈdʒʊkəʃən/，治疗药物监测教育 Pharmacogenetic Testing Reimbursement /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˌriːɪmˈbɜːrsəmənt/，药物遗传学检测报销 Pharmacokinetic-Pharmacodynamic Tolerance /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈtɒlərəns/，药代-药效学耐受性 Therapeutic Drug Monitoring Implementation /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ɪmˈpleɪmənt/，治疗药物监测实施 Pharmacogenetic Testing Cost-Effectiveness /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˌkɒst ɪˈfektɪvnəs/，药物遗传学检测成本效益 Pharmacokinetic-Pharmacodynamic Variability /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk 变异性 Therapeutic Drug Monitoring Policy /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈpɒləsi/，治疗药物监测政策 Pharmacogenetic Testing Laboratory Accreditation /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ læbərətɔːri əˈkredɪˈteɪʃən/，药物遗传学检测实验室认证 Pharmacokinetic-Pharmacodynamic Model Validation /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈmɒdəl vælɪˈdeɪʃən/，药代-药效学模型验证 Therapeutic Drug Monitoring Clinical Practice Guidelines /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈklɪnɪkəl præktɪs ˈɡaɪdlaɪnz/，治疗药物监测临床实践指南 Pharmacogenetic Testing Regulatory Requirements /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˌregjʊˈleɪtəri rɪˈkwaɪərmənts/，药物遗传学检测监管要求 Pharmacokinetic-Pharmacodynamic Parameter Estimation /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk pəˈræmɪtər ɛˈsteɪʃən/，药代-药效学参数估计 Therapeutic Drug Monitoring Data Analysis /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈdeɪtə əˈnæləsɪs/，治疗药物监测数据分析 Pharmacogenetic Testing Ethical Considerations /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ɛθɪkəl kənˈsɪdəˈreɪʃəns/，药物遗传学检测伦理考量 Pharmacokinetic-Pharmacodynamic Simulation Study /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk sɪmjuˈleɪʃən stʌdɪ/，药代-药效学模拟研究 Therapeutic Drug Monitoring Training Program /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈtreɪnɪŋ prəˈɡræm/，治疗药物监测培训计划 Pharmacogenetic Testing Coverage Policy /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˈkʌvərɪdʒ ˈpɒləsi/，药物遗传学检测覆盖政策 Pharmacokinetic-Pharmacodynamic Validation Study /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk vælɪˈdeɪʃən stʌdɪ/，药代-药效学验证研究 Therapeutic Drug Monitoring Quality Assurance /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈkwɒlɪtɪ əˈʃʊərəns/，治疗药物监测质量保证 Pharmacogenetic Testing Cost-Benefit Analysis /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˈkɒst bɛnɪˈfɪt əˈnæləsɪs/，药物遗传学检测成本效益分析 Pharmacokinetic-Pharmacodynamic Sensitivity Analysis /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈsensəˈtɪvəti əˈnæləsɪs/，药代-药效学敏感性分析 Therapeutic Drug Monitoring Implementation Plan /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ɪmˈpleɪmənt plæn/，治疗药物监测实施计划 Pharmacogenetic Testing Reimbursement Policy /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˌriːɪmˈbɜːrsəmənt ˈpɒləsi/，药物遗传学检测报销政策 Pharmacokinetic-Pharmacodynamic Variability Analysis /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk 变异性分析 Therapeutic Drug Monitoring Clinical Decision Support /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈklɪnɪkəl dɪˈsɪʒən səˈpɔːrt/，治疗药物监测临床决策支持 Pharmacogenetic Testing Regulatory Compliance /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˌregjʊˈleɪtəri kəmˈplaɪəns/，药物遗传学检测监管合规 Pharmacokinetic-Pharmacodynamic Parameter Optimization /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk pəˈræmɪtər ˈɒptɪmaɪˈzeɪʃən/，药代-药效学参数优化 Therapeutic Drug Monitoring Education Program /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ɛˈdʒʊkəʃən prəˈɡræm/，治疗药物监测教育计划 Pharmacogenetic Testing Ethical Review /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ɛθɪkəl rɪˈvjuː/，药物遗传学检测伦理审查 Pharmacokinetic-Pharmacodynamic Simulation Tool /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk sɪmjuˈleɪʃən tʊl/，药代-药效学模拟工具 Therapeutic Drug Monitoring Policy Development /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈpɒləsi dɪˈvɛləpmənt/，治疗药物监测政策制定 Pharmacogenetic Testing Coverage Determination /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˈkʌvərɪdʒ dɪˈtɜːrmɪˈneɪʃən/，药物遗传学检测覆盖判定 Pharmacokinetic-Pharmacodynamic Validation Protocol /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk vælɪˈdeɪʃən prəˈtəʊkɒl/，药代-药效学验证方案 Therapeutic Drug Monitoring Quality Control Procedure /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ˈkwɒlɪtəkənˈtrəʊl prəˈsiːdʒər/，治疗药物监测质量控制程序 Pharmacogenetic Testing Cost-Effectiveness Analysis /fɑːrməˈkɒdʒənətɪk ˈtestɪŋ ˌkɒst ɪˈfektɪvnəs əˈnæləsɪs/，药物遗传学检测成本效益分析 Pharmacokinetic-Pharmacodynamic Sensitivity Analysis Method /fɑːrməˈkɒkɪnətɪk fɑːrməˈkɒdʒənətɪk ˈsensəˈtɪvəti əˈnæləsɪs ˈmeθəd/，药代-药效学敏感性分析方法 Therapeutic Drug Monitoring Implementation Strategy /θerəˈpjuːtɪk drʌɡ ˈmɒnɪtərɪŋ ɪmˈpleɪmənt ˈstrætədʒi/，治疗药物监测实施策略根据药理作用分类 Antibiotic /ˈæntibaɪətɪk/，抗生素 β-lactam antibiotics /ˌbaɪlæktn ænˈtaɪbɪɒtɪks/，β-内酰胺类抗生素 Macrolides /məˈkrɒlɪdz/，大环内酯类 Vancomycin /ˈvænkəʊmʌɪsɪn/，万古霉素 Aminoglycosides /əˈmɪnəʊɡlaɪkəʊsaɪd/，氨基糖苷类 Analgesic /əˈnælʤɪsɪk/，镇痛药 Opioids /ˈoʊpiɔɪdz/，阿片类药物 NSAIDs /ˌɛnseˈaɪd/，非甾体抗炎药 Anti-inflammatory /ˌæntɪˈflæmətɔːri/，抗炎药 Corticosteroids /kɔːtɪˈkoʊstərɔɪdz/，糖皮质激素 Cardiovascular /ˌkɑːrdɪoˈvæskjələr/，心血管药物 ACE inhibitors /ˈeɪsi aɪnˈhaɪbɪtərz/，血管紧张素转换酶抑制剂 β-blockers /ˈbeta blɒkəz/，β受体阻滞剂 Warfarin /ˈwɔːrfərɪn/，华法林 Antineoplastic /ˌæntɪˈniːəplæstɪk/，抗肿瘤药 Methotrexate /ˈmeθətrɛkseɪt/，甲氨蝶呤 Cyclophosphamide /ˈsaɪkləʊfɒsfəmaɪd/，环磷酰胺 Antiepileptic /ˌæntiˈɛpɪlɛptɪk/，抗癫痫药 Phenytoin /ˈfɛnɪdoʊɪn/，苯妥英钠 Carbamazepine /kɑːrˈbæməzeɪpɪn/，卡马西平 Antipsychotic /ˌæntɪˈsaɪkɒtɪk/，抗精神病药 Clozapine /ˈkləʊzəpiːn/，氯氮平 Lithium /ˈlɪθiəm/，锂盐 Antidiabetic /ˌændɪəˈbetɪk/，降糖药 Insulin /ˈɪnsəlɪn/，胰岛素 Metformin /ˈmetfɔːmaɪd/，二甲双胍 Antihistamine /ˌæntɪˈhɪstəmiːn/，抗组胺药 Diphenhydramine /ˌdaɪfənˈhɪdrəmiːn/，苯海拉明 Immunosuppressant /ˌɪmjuːnəʊˈsʌpresnt/，免疫抑制剂 Cyclosporine /ˈsaɪkləspɔːriːn/，环孢素 Tacrolimus /tækˈrɒlɪməs/，他克莫司 Antiviral /ˌæntɪˈvaɪrəl/，抗病毒药 Acyclovir /ˈæsɪkloviːr/，阿昔洛韦 Oseltamivir /ɒsɛlˈtæmɪvɪr/，奥司他韦 Antifungal /ænˈtɪfʌŋɡəl/，抗真菌药 Fluconazole /fʊkˈɒnkəzoʊl/，氟康唑 Amphotericin B /æmˈfɒtərɪsɪn B/，两性霉素B Antiparasitic /ænˈtɪpærəsɪtɪk/，抗寄生虫药 Artemisinin /ɑːrˈtɛmɪsɪniːn/，青蒿素 Respiratory /rɪˈspɪrətɔːri/，呼吸系统药物 Salbutamol /ˈsælbjuːtəmɒl/，沙丁胺醇 Theophylline /θiːəˈfɪliːn/，茶碱 Gastrointestinal /ˌɡæstrəʊɪnˈtestɪnəl/，消化系统药物 Omeprazole /ˌəʊməˈprɒzəl/，奥美拉唑 Loperamide /4-hydroxy-N,N-dimethyl-2,2-diphenylbutanamide/，洛哌丁胺 Urological /ˌjʊərəˈlɒdʒɪkəl/，泌尿系统药物 Tamsulosin /0.4 mg OD/，坦索罗辛 Hematological /haɪˈmætəlɒdʒɪkəl/，血液系统药物 Heparin /ˈhɛpərɪn/，肝素 Warfarin /ˈwɔːrfərɪn/，华法林 Endocrine /ɛnˈdaɪkrɪn/，内分泌系统药物 Levothyroxine /lɛˈvoθaɪroksɪn/，左甲状腺素钠 Insulin /ˈɪnsəlɪn/，胰岛素 Musculoskeletal /ˌmʌskjuːləʊˈskɛlɪtəl/，骨骼肌肉系统药物 Alendronate /əˈlɛndrəneɪt/，阿仑膦酸钠 Neurological /nʊrəˈlɒdʒɪkəl/，神经系统药物 Levodopa /ləˈvoʊdəpə/，左旋多巴 Gabapentin /ɡæbəˈpɛntɪn/，加巴喷丁 Local Anesthetic /ˌloʊkəl əˈnɛstɪtʃək/，局部麻醉药 Lidocaine /ˈlaɪdəkeɪn/，利多卡因 Contrast Agent /ˈkɒntræst ˌeɪʤənt/，造影剂 Iohexol /ˌaɪoʊˈheksɒl/，碘海醇 Antidote /ˈæntɪdoʊt/，解毒剂 Naloxone /4mg IV/，纳洛酮 Vitamin /ˈvaɪtəmɪn/，维生素 Vitamin K1 /phylloquinone/，维生素K1 Biologic /baɪˈɒlədʒɪk/，生物制品 Infliximab /ɪnˈflɪksɪmæb/，英夫利昔单抗 Radiopharmaceutical /ˌreɪdiəʊˈfɑːməsjuːtɪkəl/，放射性药物 Technetium-99m /tɛkˈniːʃiəm/，锝-99m Other /ˈʌðər/ Heparin /ˈhɛpərɪn/，肝素（抗凝监测） Insulin /ˈɪnsəlɪn/，胰岛素（血糖监测）

2025-11-18

·蒲公英Ouryao

参比制剂（第98批）名单发布

转自：国家药监局编辑：随风 2025年11月18日，国家药监局发布了第98批次仿制药一致性评价参比制剂目录，新增品种48个。经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第九十八批），特此通告。新增品种：盐酸来罗西利片、罗氟司特乳膏、甲苯磺酸缬苯那嗪胶囊、甲苯磺酸纳地美定片、雌二醇透皮喷雾剂、硫酸锌注射液、利塞膦酸钠肠溶片/碳酸钙D3泡腾颗粒组合包装、氢溴酸替格列汀口崩片、缬沙坦西尼地平片、乳酸维持液含葡萄糖10%、丁溴东莨菪碱片、硫酸吗啡口崩片、马立巴韦片、布瑞哌唑片、盐酸贝凡洛尔片、盐酸普罗帕酮缓释胶囊、阿达帕林凝胶、盐酸美金刚缓释胶囊、右旋糖酐羟丙甲纤维素滴眼液、利福昔明片、甲磺酸奥希替尼片、盐酸氨溴索缓释胶囊、盐酸依特卡肽注射液、盐酸依特卡肽注射液、双氯芬酸钠双释放肠溶胶囊、奈帕芬胺滴眼液、低钙腹膜透析液（碳酸氢盐-G1.5%）、阿达帕林过氧苯甲酰凝胶、玻璃酸钠滴眼液、左氧氟沙星片等；仿制药参比制剂目录（第98批）

100 项与奈帕芬胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05143	奈帕芬胺	S01BC10	DB06802

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
黄斑水肿	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2015-11-04
术后炎症	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2015-11-04
眼部炎症	日本	Novartis Pharma KK	2010-10-27
糖尿病性黄斑水肿	欧盟	Novartis Europharm Ltd.	2007-12-11
糖尿病性黄斑水肿	冰岛	Novartis Europharm Ltd.	2007-12-11
糖尿病性黄斑水肿	列支敦士登	Novartis Europharm Ltd.	2007-12-11
糖尿病性黄斑水肿	挪威	Novartis Europharm Ltd.	2007-12-11
术后疼痛	欧盟	Novartis Europharm Ltd.	2007-12-11
术后疼痛	冰岛	Novartis Europharm Ltd.	2007-12-11
术后疼痛	列支敦士登	Novartis Europharm Ltd.	2007-12-11
术后疼痛	挪威	Novartis Europharm Ltd.	2007-12-11
炎症	美国	Harrow, Inc.	2005-08-19
疼痛	美国	Harrow, Inc.	2005-08-19

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非增殖性糖尿病视网膜病变	临床3期	-	Alcon Research Ltd.	2013-06-01
眼睛疼痛	临床3期	法国	Alcon Research Ltd.	2005-11-01
白内障	临床3期	美国	Alcon Research Ltd.	2005-09-01
细菌性结膜炎	临床2期	-	Alcon Research Ltd.	2011-01-01
糖尿病性视网膜病变	临床2期	-	Alcon Research Ltd.	2008-11-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03499873 (CTgov)	临床3期	白内障 \| 疼痛 \| 炎症 ... 更多	448	Nepafenac (Nepafenac 0.3% Opthalmic Suspension)	築簾鹹襯觸網顧壓築遞: Mean Difference (Net) = -0.026 (90% CI, -0.124 ~ 0.073)	-	2021-02-16
				Nepafenac (Ilevro 0.3% Opthalmic Suspension)
NCT03025945 (CTgov)	N/A	黄斑水肿	662	Nepafenac 0.3% (Nepafenac 0.3%)	鬱憲衊構範範選願齋襯(膚築餘製鹹衊鑰窪鬱遞) = 網衊簾築遞齋蓋餘鏇糧製獵憲築鹹壓顧獵網鏇 (鑰糧鹽夢願遞憲顧膚醖, 0.13) 更多	-	2018-12-14
				Saline Solution (Saline Solution)	鬱憲衊構範範選願齋襯(膚築餘製鹹衊鑰窪鬱遞) = 製鑰夢簾築獵鑰鑰窪遞製獵憲築鹹壓顧獵網鏇 (鑰糧鹽夢願遞憲顧膚醖, 0.18) 更多
NCT01847638 (QD, CTgov)	N/A	白内障 \| 眼部炎症 \| 视网膜水肿	50	bromfenac (Prolensa (Bromfenac 0.07%))	簾夢遞鹽鹽簾壓齋網鬱(壓齋製窪鏇構範淵齋餘) = 窪鏇餘醖築鏇鹹觸觸鬱餘鑰製構鬱觸壓願獵製 (窪蓋艱鑰壓醖鹽願齋製, .3) 更多	-	2018-11-14
				nepafenac (Ilevro (Nepafenac 0.3%))	簾夢遞鹽鹽簾壓齋網鬱(壓齋製窪鏇構範淵齋餘) = 築獵憲構淵築願鏇糧齋餘鑰製構鬱觸壓願獵製 (窪蓋艱鑰壓醖鹽願齋製, .4) 更多
NCT02515045 (CTgov)	临床4期	白内障	59	triamcinolone+moxifloxacin+vancomycin (TriMoxiVanc)	窪鏇選窪遞獵壓觸繭膚(膚壓廠廠膚艱築齋繭顧) = 積淵鹽願壓鬱醖簾艱網襯網窪築製鹹餘夢憲選 (窪鬱鹹網積襯餘製網觸, 13.05) 更多	-	2017-08-22
				triamcinolone+moxifloxacin+vancomycin+Ilevro (TriMoxiVanc + Ilevro)	窪鏇選窪遞獵壓觸繭膚(膚壓廠廠膚艱築齋繭顧) = 觸襯膚簾觸膚壓齋製襯襯網窪築製鹹餘夢憲選 (窪鬱鹹網積襯餘製網觸, 11.55) 更多
NCT01853072 (Pubmed \| Ophthalmology) 人工标引	临床3期	糖尿病性视网膜病变	615	Nepafenac	築製鹽壓構膚艱遞獵鹽(壓壓餘憲獵窪醖遞築糧) = 製醖鑰遞廠構願願鬱憲簾鹽繭淵繭顧簾願構選 (遞範製鏇糧衊顧範築憲 ) 更多	积极	2017-06-01
				vehicle	築製鹽壓構膚艱遞獵鹽(壓壓餘憲獵窪醖遞築糧) = 齋夢繭願醖觸鹽顧鏇簾簾鹽繭淵繭顧簾願構選 (遞範製鏇糧衊顧範築憲 ) 更多
NCT00782717 \| NCT00939276 (Pubmed \| Br J Ophthalmol)	临床2期	糖尿病性视网膜病变	175	Nepafenac ophthalmic suspension 0.1%	衊獵繭鏇顧憲鑰鹽範糧(選製淵齋網廠艱選襯製) = 蓋鬱蓋壓壓範構鏇鏇衊顧鏇選夢構繭夢鹹襯蓋 (醖繭齋鬱壓鹽廠積壓遞, 1.4 ~ 12.3) 更多	-	2017-04-01
				Vehicle	衊獵繭鏇顧憲鑰鹽範糧(選製淵齋網廠艱選襯製) = 鏇顧構網網鹹鬱構醖廠顧鏇選夢構繭夢鹹襯蓋 (醖繭齋鬱壓鹽廠積壓遞, 9.9 ~ 27.6) 更多
APAO2017	临床3期	糖尿病性白内障	-	Nepafenac 0.3%	糧蓋夢壓憲製夢鹽醖簾(鏇艱網齋鏇鹽襯繭憲憲) = Rates of treatment-related adverse events were low in both groups (study-1: 2.7% vs 2.3%; study-2: 2.0% vs 2.7%) 簾憲膚網選壓積淵鬱齋 (範蓋膚築艱構簾齋簾鑰 )	积极	2017-03-01
				Vehicle
NCT03025945 (Pubmed \| BMC Ophthalmol)	N/A	黄斑水肿	1,000	Topical nepafenac 0.3%	鏇構衊淵憲製選築廠蓋(鑰餘網獵壓衊遞餘構願) = 範衊繭淵構積餘夢簾糧鹹鏇膚壓顧鏇艱獵夢構 (遞獵膚鏇選積夢鏇製觸 )	-	2017-02-20
				Placebo	鏇構衊淵憲製選築廠蓋(鑰餘網獵壓衊遞餘構願) = 醖夢醖獵範壓獵鹹築獵鹹鏇膚壓顧鏇艱獵夢構 (遞獵膚鏇選積夢鏇製觸 )
NCT01331005 (Pubmed \| Retina) 人工标引	临床2期	糖尿病性黄斑水肿	125	nepafenec	範遞艱選齋壓願觸繭衊(鹽範襯淵醖獵築鬱構繭) = 簾簾繭鬱糧膚顧衊艱糧觸鹽鹹鑰廠簾蓋糧鬱襯 (築廠壓鏇襯廠製願簾淵 ) 更多	不佳	2015-05-01
				Placebo	範遞艱選齋壓願觸繭衊(鹽範襯淵醖獵築鬱構繭) = 餘鑰遞構顧製廠夢鹽遞觸鹽鹹鑰廠簾蓋糧鬱襯 (築廠壓鏇襯廠製願簾淵 ) 更多
NCT01331005 (CTgov)	临床2期	糖尿病性黄斑水肿	125	Nepafenac Vehicle (Placebo)	鬱範膚糧製憲鬱網膚顧(範鹹壓簾鏇網鹹網餘廠) = 艱獵鹽夢鑰簾蓋選觸廠遞壓夢選憲齋簾繭鏇鹹 (積範憲簾簾選選獵艱構, 窪鏇範築簾衊廠遞膚壓 ~ 餘鏇淵範積繭願淵齋網) 更多	-	2015-01-16
				nepafenac (Nepafenac 0.1% Drops)	鬱範膚糧製憲鬱網膚顧(範鹹壓簾鏇網鹹網餘廠) = 鬱簾顧鏇鹹範鏇淵醖觸遞壓夢選憲齋簾繭鏇鹹 (積範憲簾簾選選獵艱構, 積糧衊顧糧積顧網廠襯 ~ 願積築遞衊膚鬱選繭觸) 更多