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Clinical research and regulatory affairs.

SCI

中文名称：临床研究和监管事务。

ISSN：1060-1333
出版周期：Four no. a year

发文量：87

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1.Laboratory information and management system: A tool to increase laboratory productivity

机译：实验室信息和管理系统：一种提高实验室生产率的工具
- 作者：Sunil K. Dubey;Amit An;Hemanth Jangala
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- LIMS;
- database;
- reporting;
- decision;
- quality control;
- management tool;
- validation;
- GAMP V model;
2.Determination of pharmacokinetics of itraconazole in healthy Indian subjects under fed condition and incurred sample analysis using a validated liquid chromatography tandem mass spectrometric method

机译：进食条件下伊曲康唑在印度健康受试者中的药代动力学测定以及采用验证的液相色谱串联质谱法进行样品分析
- 作者：Anil K. Patni;Tausif Monif;Arshad H. Khuroo;Sunil S. Iyer;Rakesh Jain;Sudershan Kumar
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- Pharmacokinetics;
- Indian population;
- incurred sample re-analysis;
3.Prescription to over-the-counter movement and its regulations

机译：场外交易处方及其规定
- 作者：S. K. Dubey;R. D. Ukawala;D. Jha
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- Rx to OTC movement;
- Rx to OTC switch;
- prescription druq movement;
- OTC;
- over-the-counter;
4.The opportunities and challenges in conducting clinical trials globally

机译：全球开展临床试验的机遇与挑战
- 作者：Navneeta Bansal
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- Clinical trial;
- challenges;
- globally;
5.Understanding the reality: Is India losing standing for clinical research?

机译：了解现实：印度是否会失去临床研究的地位？
- 作者：Sameer Parekh Sunil Shewale
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- India;
- clinical research;
- losing interest;
- research concern;
- clinical trial issues;
6.Selective, sensitive, and rapid liquid chromatography -tandem mass spectrometry method for determination of Glimepiride in human plasma

机译：选择性，灵敏，快速液相色谱-串联质谱法测定人血浆中的格列美脲
- 作者：Lalit Dutta;Syed Imran Ahmad;Sanjeev Mishra;Arshad Khuroo;Tausif Monif
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- Glimepiride;
- LC-MS-MS;
- quantitation;
7.Steady-state pharmacokinetics and bioequivalence study of quetiapine fumarate film-coated tablets 300 mg in adult schizophrenic patients

机译：成人富马酸喹硫平薄膜衣片300mg的稳态药代动力学和生物等效性研究
- 作者：Madhava Rao Betha;Sudhakar Koundinya Tippabhotla;Seep Yergude;Sohel Md. Khan
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- Quetiapine;
- bioequivalence;
- WinNonlin;
- LC-MS/MS;
- schizophrenia;
- intrapatient variability;
8.Blinded independent central reviews: The FDA weighs in

机译：盲目独立的中央审查：FDA权衡
- 作者：Richard C. Walovitch
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Blinded review;
- FDA Guidance document;
- imaging;
- imaging contract research organization;
9.Reducing the average number of patients needed in a phase II trial through novel design

机译：通过新颖的设计减少II期试验所需的平均患者数
- 作者：James M. S. Wason
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Adaptive design;
- biomarkers;
- group-sequential design;
- multi-arm trials;
- phase II clinical trials;
10.Single dose pharmacokinetics and bioequivalence of conjugated estrogens (0.625 mg x 2) tablets in healthy post-menopausal female subjects in fasting and fed studies

机译：在禁食和进食研究中，健康绝经后女性受试者的共轭雌激素（0.625 mg x 2）片剂单剂量药代动力学和生物等效性
- 作者：Sudhakar Koundinya Tippabhotla;Mukesh Nakkawar;Chaitanya Gadiko;Madhava Rao Betha;Sohel Md. Khan;Seep Yergude;Satyanarayana Thota;Raju Cheerla;Ramakrishna Battula;Venkateswarlu Vobalaboina
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Baseline correction;
- bioequivalence;
- conjugated estrogens;
- endogenous substances;
- pharmacokinetics;
11.The pharmacodynamic equivalence of Orlistat 60 mg capsule. An open label, balanced, randomized, multiple-dose, cross-over pharmacodynamic end-point bioequivalence study in healthy, adult, human Asian Indian subjects under fed conditions

机译：奥利司他60 mg胶囊的药效学等效性。在健康，成人，人类亚洲印度裔受试者进食条件下进行的开放标签，均衡，随机，多剂量，交叉药代动力学终点生物等效性研究
- 作者：Sudershan Kumar;Tausif Monif;Rachna Arora;Arshad Khuroo;Rakesh Jain;Simrit Reyar;Priya Ranjan Prasad Verma;Shireen Rao
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Bioequivalence;
- cross-over study;
- orlistat capsule;
- pharmacodynamics;
12.Pharmacokinetics of two formulations of alendronate sodium/ cholecalciferol (vitamin D_3) tablets 70mg/5600IU: An open-label, randomized, single-dose, two-treatment, two-period, two-sequence, cross-over, bioequivalence study

机译：两种阿仑膦酸钠/胆钙化固醇（维生素D_3）片剂70mg / 5600IU的药代动力学：开放标签，随机，单剂量，两次治疗，两个时期，两个序列，交叉，生物等效性研究
- 作者：Sudhakar Koundinya Tippabhotla;Satyanarayana Thota;Sohel Md. Khan;Chaitanya Gadiko;Seep Yergude;Raju Cheerla;Mukesh Nakkawar;Madhava Rao Betha;Ramakrishna Battula;Venkateswarlu Vobalaboina
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Alendronate;
- baseline correction;
- bioequivalence;
- cholecalciferol;
- endogenous substances;
13.Advance Oracle Clinical Software tool used in clinical research from patient data collection to data base lock

机译：从患者数据收集到数据库锁定的临床研究中使用的高级Oracle临床软件工具
- 作者：Vasanth Kumar Kunithala;Ahamed Kabeer;Sateesh Kumar Vemula
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Data entry;
- data lock;
- data validation;
- discrepancy management;
- E-data amp;
- SAE reconciliation;
- oracle clinical classic software tool;
- patient enrollment;
14.Steady state bioequivalence study of dipyridamole ER and acetyl salicylic acid 200 mg + 25 mg capsules in adult healthy male and female volunteers under fasting condition

机译：禁食条件下成年健康男女志愿者双嘧达莫ER和乙酰水杨酸200 mg + 25 mg胶囊的稳态生物等效性研究
- 作者：Sudhakar Koundinya Tippabhotla;Seep Yergude;Chaitanya Gadiko;Satyanarayana Thota;Sohel Md. Khan;Ramakrishna Battula;Venkateswarlu Vobalaboina
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
- Aspirin;
- dipyridamole;
- steady state pharmacokinetics;
- stroke;
15.Clinical Research and Regulatory Affairs invites you to submit your research

机译：临床研究与法规事务邀请您提交研究报告
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
16.Statement of Retraction

机译：收回声明
- 期刊名称：《Clinical research and regulatory affairs.》 | 2013年第4期
17.Comparison of EMA and FDA guidelines for drug interactions: An overview

机译：EMA和FDA药物相互作用指南的比较：概述
- 作者：Slobodan M. Jankovic
- 期刊名称：《Clinical research and regulatory affairs.》 | 2014年第4期
- Comparison of requirements;
- drug interactions;
- guidelines;
18.Assessment of internet gaming disorder in clinical research: Past and present perspectives

机译：在临床研究中评估网络游戏障碍：过去和现在的观点
- 作者：Halley M. Pontes Mark D. Griffiths
- 期刊名称：《Clinical research and regulatory affairs.》 | 2014年第4期
- Assessment;
- DSM-5;
- internet addiction;
- internet gaming disorder;
- gaming addiction;
19.Development and validation of a LC-ESf-MS/IVtS method for simultaneous quantification of olmesartan and hydrochlothiazide in human K3 EDTA plasma and its application to pharmacokinetic bsostudy

机译：同时定量人K3 EDTA血浆中奥美沙坦和氢氯噻嗪的LC-ESf-MS / IVtS方法的开发和验证及其在药代动力学研究中的应用
- 作者：Ajay Kumar;Priya Ranjan Prasad Verma;Tausif Monif;Arshad H;Khuroo;Sunil S. Iyer
- 期刊名称：《Clinical research and regulatory affairs.》 | 2014年第4期
- Bioanalytical method development;
- LC-MS/MS;
- olmesartan;
- hydrochlorothiazide;
- solid phase extraction;
20.A newer dimension to regulation of ethics committees in India

机译：印度道德委员会监管的新维度
- 作者：lla Narang;Ishita Kumari Bharota;Sheikh Raisuddin;Gaurav Kumar Jain;Nidhi Bharal Agarwal
- 期刊名称：《Clinical research and regulatory affairs.》 | 2014年第4期
- Ethics committee;
- registration;
- rule 122DD;
- schedule Y;
21.Current regulatory systems for clinical trials in Japan: Still room for improvement

机译：日本现行的临床试验管理体系：仍有改进的空间
- 作者：Hiroaki Yanagawa
- 期刊名称：《Clinical research and regulatory affairs.》 | 2014年第4期
- Clinical trials;
- Japanese infrastructure;
- regulation;
- registration trials;
- research ethics;
22.Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel

机译：经颅直流电刺激（tDCS）的临床和研究用途的监管注意事项：专家小组的审查和建议
- 作者：F;Fregni;M. A. Nitsche;C. K. Loo;A. R. Brunoni;P. Marangolo;J. leite;S. Carvalho;N. Bolognini;W. Caumo;N. j. Paik;M. Simis
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- tDCS;
- regulatory;
- safety;
23.Challenges of risk-based monitoring of clinical trials

机译：基于风险的临床试验监测的挑战
- 作者：Marko Simovic Natasa Nikolic
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Clinical trial monitoring;
- inspeciion findings;
- risk-based monitoring;
24.Inter-ethnic differences in drug response: Implications for drug development and complying with drug regulation

机译：族裔间药物反应差异：对药物开发和遵守药物法规的影响
- 作者：Rashmi R. Shah
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Bridging studies;
- drug development;
- pharmacodynamic polymorphisms;
- polymorphic drug metabolism;
- regulatory requirements;
25.EU regulatory guidelines for the clinical evaluation of adjuvants

机译：欧盟法规对佐剂的临床评估
- 作者：Bettina Klug;Patrick Celis;Robin Ruepp;James S. Robertson
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Adjuvant;
- data requirements;
- European legislation;
- product development.;
- vaccine;
26.Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process-Findings from a qualitative study

机译：关于适应性设计的思考，加速了有希望的治疗试验（ADAPT-IT）过程-定性研究的发现
- 作者：Timothy C. Guetterman;Michael D. Fetters;Laurie J. Legocki;Samkeliso Mawocha;William G. Barsan;Roger J. Lewis;Donald A. Berry;William J. Meurer
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Adaptive clinical trials;
- emergency medicine;
- neurological emergencies;
- qualitative research;
27.Industry-funded clinical trials: Beneficial or harmful?

机译：由行业资助的临床试验：有益还是有害？
- 作者：Jing Zhang;Yiping Yuan
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Clinical trials;
- industry-funded;
- sponsorship bias;
28.The regulation of fecal microbiota for transplantation: An international perspective for policy and public health

机译：粪便微生物群移植的监管：政策和公共卫生的国际视角
- 作者：Carolyn A. kdelstein;Zain Kassani;Jamie Daw;Mark B. Smith
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
29.Linezolid in South Africa: The regulatory authority's role in supporting access to improved treatment regimens for drug-resistant tuberculosis

机译：南非的利奈唑胺：监管机构在支持获得改善的抗药性肺结核治疗方案中的作用
- 作者：Julia E. Hill
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Access to medicines;
- affordability;
- intellectual property law reform;
- regulatory reform;
- import waiver;
30.Opportunities to improve clinical trial design in urothelial bladder cancer

机译：改善尿路上皮膀胱癌临床试验设计的机会
- 作者：Joanne W. Chiu Srikala S. Sridhar
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Advanced urothelial carcinoma;
- biological therapies;
- bladder cancer;
- trial design;
31.Issues in regulating E-cigarette clinical research

机译：规范电子烟临床研究的问题
- 作者：Christopher Bullen Oliver Knight-West
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Clinical trials;
- electronic cigarettes;
- regulator;
32.Considerations for clinical trial design with obesity-related devices

机译：使用肥胖相关设备进行临床试验设计的注意事项
- 作者：Herbert Lerner Martha W. Betz
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Obesity;
- sham;
- weight loss;
33.Bioequivalence studies in Europe before and after 2010

机译：欧洲在2010年之前和之后的生物等效性研究
- 作者：Chrysa Daousani;Vangelis Karalis
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- European Medicines Agency;
- guidelines pharmacokinetics;
34.Adaptive designs for comparative effectiveness research trials

机译：用于比较有效性研究试验的自适应设计
- 作者：John A. Kairalla;Christopher S. Coffey;Mitchell A. Thomann;Ronald I. Shorr Keith E. Muller
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Power analysis;
- pragmatic trials;
- sample size re-estimation;
35.Evaluating the impacts of the FDA's guidance for patient-reported outcomes (PROs) measures on clinical trial-based approved drug product labeling claims, 2006-2014

机译：评估FDA的患者报告结果（PRO）措施指南对基于临床试验的已批准药品标签声明的影响，2006-2014年
- 作者：Andrew C. Palsgrove
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- End-point;
- FDA;
- prescribing information;
- patient-reported outcomes;
36.Special population considerations and regulatory affairs for clinical research

机译：临床研究的特殊人群注意事项和法规事务
- 作者：Kristin N. Grimsrud;Catherine M. T. Sherwin;Jonathan E. Constance;Casey Tak;Athena I . Zuppa;Michael G. Spigarelli;Nicole L. Mihalopoulos
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Geriatrics;
- human subject research;
- pediatrics;
- pregnancy;
- regulations;
37.Clinical trial design methodologies for advanced sarcoma therapy

机译：晚期肉瘤治疗的临床试验设计方法
- 作者：Bradley J. Petek;Seth M. Pollack;Anastasia Constantinidou Robin L. Jones
- 期刊名称：《Clinical research and regulatory affairs.》 | 2015年第4期
- Cancer treatment;
- clinical trial design;
- histological sub-type;
- sarcoma;
- systemic therapy;
38.Certification in good clinical practice and clinical trial quality: A retrospective analysis of protocol adherence in four multicenter trials in the USA

机译：良好临床实践和临床试验质量的认证：对美国四项多中心试验中方案依从性的回顾性分析
- 作者：Jean Marc C. Haeusler
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第2期
39.Bioequivalence model for evaluation of Losartan in human plasma with special reference to drug-metabolite ratio

机译：用于评估人血浆中氯沙坦的生物等效性模型，并特别考虑药物代谢物比率
- 作者：Dipanjan Goswami;Sanjay Gurule;Arshad H. Khuroo
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第4期
40.Comparison of effect of fasting and of five different diets on the bioavailability of single oral dose of clarithromycin 500 mg extended release tablet

机译：空腹和五种不同饮食对单次口服克拉霉素500毫克缓释片生物利用度的影响比较
- 作者：Sanjay J. Gurule;Tausif Monif;Priya Ranjan Prasad Verma
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第4期
41.Population pharmacokinetics of doxorubicin in Indian cancer patients using NONMEM

机译：使用NONMEM在印度癌症患者中阿霉素的群体药代动力学
- 作者：Vijay S. Kumar;Harish K. Kaushik;Satish B. Kumar
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第4期
42.Physicians knowledge and attitudes toward scheduling

机译：医师对调度的知识和态度
- 作者：Jonathon M. Parker;E. Paul Larrat
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第2期
43.Development and characterization of a carvedilol-loaded self-microemulsifying delivery system

机译：卡维地洛负载的自微乳化输送系统的开发与表征
- 作者：Sandeep Kumar Singh Priya Ranjan Prasad Verma and Balkishen Razdan
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第3期
44.Does linezolid-induced tongue discoloration need further investigation?

机译：利奈唑胺引起的舌头变色需要进一步研究吗？
- 作者：Tony J. Eid Patrick DiTullio and Sachin A. Shah
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第3期
45.Dissolution of poorly water-soluble drugs in biphasic media using USP 4 and fiber optic system

机译：使用USP 4和光纤系统在双相介质中溶解水溶性差的药物
- 作者：Saroj Vangani;Xiaoling Li;Peter Zhou;Mary Anne Del Barrio;Rick Chiu;Nina Cauchon;Ping Gao;Cesar Medina;Bhaskara Jasti
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第2期
46.Approaches and issues towards development of efficient mucosal vaccines against pneumonia

机译：开发有效的抗肺炎粘膜疫苗的途径和问题
- 作者：Dilip Devineni Simon Paulos Ruhi Ubale Bindhu Rayaprolu and Ravi Palaniappan
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第3期
47.Population pharmacokinetics of cisplatin in Asian Indian cancer patients

机译：亚洲印度裔癌症患者中顺铂的群体药代动力学
- 作者：Harish K. Kaushik;Vijay S. Kumar;Satish B. Kumar
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第4期
48.Liquid chromatographic tandem mass spectrometric validated method for pharmacokinetic estimation of flecainide in human plasma

机译：液相色谱串联质谱法验证人血浆中氟卡尼的药代动力学
- 作者：Dipanjan Goswami;Ajay Kumar;Arshad H. Khuroo;Tausif Monif;Sanjay Gurule;Nageshwar R. Thudi;Vikesh K Shrivastav;Sunil K Dubey
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第2期
49.Disposition kinetics of a dipeptide ester prodrug of acyclovir and its metabolites following intravenous and oral administrations in rat

机译：大鼠静脉内和口服给药后，阿昔洛韦及其代谢产物的二肽酯前药的处置动力学
- 作者：Ravi S. Talluri Ripal Gaudana Sudharshan Hariharan Ritesh Jain and Ashim K. Mitra
- 期刊名称：《Clinical research and regulatory affairs.》 | 2009年第3期
50.Addressing issues affecting clinical trials in Brazil

机译：解决影响巴西临床试验的问题
- 作者：Karen Politis Virk
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Clinical trials;
- Brazil;
- language;
- culture;
51.Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol

机译：临床试验中的盲法评估：统计方法的综述和盲法评估方案的建议
- 作者：Heejung Bang;Stephen P. Flaherty;Jafar Kolahi;Jongbae Park
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Blinding assessment;
- blinding index;
- blinding protocol;
- blinding questionnaire;
- masking;
52.Selective, sensitive, and rapid liquid chromatography-tandem mass spectrometry method for determination of Guaifenesin in human plasma

机译：选择性，灵敏和快速液相色谱-串联质谱法测定人血浆中的愈创甘油醚
- 作者：Pawan Deep Singh;Lalit Dutta;Onkar Singh;Sanjeev Mishra;Arshad Khuroo;Tausif Monif;Ayaz Ahmed;Nirmala Yadav
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Guaifenesin;
- LC-MS-MS;
- quantitation;
53.Floating drug delivery system of verapamil hydrochloride using karaya gum and HPMC

机译：使用卡拉叶胶和HPMC的盐酸维拉帕米漂浮药物输送系统
- 作者：H. V. Gangadharappa;M. Rahamath Ulla;T. M. Pramod Kumar;F. Shakeel
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Verapamil hydrochloride;
- karaya gum;
- HPMC;
- floating tablet;
- release kinetics;
54.Fluticasone propionate/salmeterol combination in children with asthma: Key cardiac and overall safety results

机译：哮喘患儿丙酸氟替卡松/沙美特罗组合：关键的心脏和总体安全性结果
- 作者：Jennifer S. Li;Paul Y. Qaqundah;Steven F. Weinstein;Craig E LaForce;Anna V. Ellsworth;Hector G. Ortega;Thomas J. Ferro
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- ECG;
- inhaled corticosteroid;
- long-acting beta-agonist;
- pediatric;
- QRS;
- QTc;
55.A simple and sensitive liquid chromatography-mass spectrometry routine method for determination of clarithromycin in human plasma: Application to a clinical pharmacokinetic study

机译：一种简单而灵敏的液相色谱-质谱联用法测定人血浆中克拉霉素的常规方法：在临床药代动力学研究中的应用
- 作者：Shiva N. V. Prasad Bathula;Seshagiri Rao JVLN
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Clarithromycin;
- LC-MS;
- human plasma;
- pharmacokinetics;
56.Stability and self-nanoemulsification efficiency of ramipril nanoemulsion containing labrasol and plurol oleique

机译：含有拉布拉索尔和油性酚的雷米普利纳米乳液的稳定性和自纳米乳化效率
- 作者：Sheikh Shafiq;Faiyaz Shakeel
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Nanoemulsion;
- ramipril;
- labrasol;
- plurol oleique;
- self-nanoemulsification efficiency;
57.Development and application of a validated stability-indicating Ultra-Performance Liquid Chromatography (UPLC) method for the determination of dantrolene and its related impurities

机译：经验证的稳定性指示超高效液相色谱（UPLC）方法用于测定丹特罗及其相关杂质的开发和应用
- 作者：Mobin A. Tawakkul;Patrick J. Faustino;Vilayat A. Sayeed;Mansoor A. Khan;Saeed R. Khan
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Dantrolene;
- UPLC;
- impurity;
- degradation;
- USP related compound A;
- B;
- C;
58.Epiduroscopy in treatment of degenerative chronic low back pain: A prospective analysis and follow-up at 60 months

机译：硬膜外窥镜治疗退行性慢性下腰痛的前瞻性分析及60个月的随访
- 作者：A. Di Donato;C. Fontana;D. Alemanno;A. Di Giacomo
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Epiduroscopy;
- endoscopy;
- chronic low back pain;
- radiculopathy;
- epidurolysis;
59.A message from the Publisher

机译：来自发布者的消息
- 作者：Elizabeth Yepez
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
60.New era of transparent compression to control bleeding from traumatic wounds: Removing the blindfold

机译：透明压缩以控制创伤性伤口出血的新时代：移除眼罩
- 作者：Sody Abby Naimer
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Bleeding wound;
- trauma;
- hemorrhage;
- compression;
- elastic adhesive dressing;
- transparent;
61.A simple and sensitive validated HPLC method for quantitative determination of cisplatin in human plasma

机译：一种简便而灵敏的高效液相色谱方法，用于定量测定人血浆中的顺铂
- 作者：K. Harish Kaushik;Vijay K. Sripuram;Satish Bedada;Narsimha Y. Reddy;G. Indira Priyadarshini;Krishna R. Devarakonda
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Cisplatin;
- HPLC;
- ethanol;
- human plasma;
62.Development and validation of rapid and sensitive HPLC method for the quantitative determination of doxorubicin in human plasma

机译：快速灵敏的高效液相色谱法测定人血浆中阿霉素的方法开发与验证
- 作者：Vijay Kumar Sripuram;Harish K. Kaushik;Satish K. Bedada;Narasimha Y. Reddy;Kiran Kumar Vangara;Praneeth Kumar S.;G. IndiraPriyadarshini;Krishna R. Devarakonda
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Doxorubicin;
- HPLC;
- human plasma;
63.Oral bioavailability enhancement of vinpocetine using self-microemulsifying drug delivery system containing long chain triglycerides: Preparation and in vitro/in vivo evaluation

机译：使用包含长链甘油三酸酯的自微乳化药物递送系统提高长春西汀的口服生物利用度：制备及体内/体外评估
- 作者：Mona H. Aburahma;Hanan M. El Laithy;Yassin El Said Hamza
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
64.A comparative bioavailability study of two formulations of itraconazole 100 mg capsule in healthy human Indian subjects under fasting conditions

机译：两种伊曲康唑100 mg胶囊在健康人印度人禁食条件下的生物利用度比较研究
- 作者：Anil. K. Patni;Tausif Monif;A. H. Khuroo;Sunil S. Iyer;Ashok. K. Tiwary
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Itraconazole;
- bioavailability;
- formulation;
65.Notification of suspected and unexpected serious adverse reactions according to the Clinical Trials Directive-A descriptive analysis of the legislation and the requirements in a European context

机译：根据临床试验指令对可疑和意料之外的严重不良反应进行通报-对法规和欧洲要求的描述性分析
- 作者：Ellen Moseholm Larsen;Jesper Grarup;Daniela Christine Gey;Karoline B. Jensen;Ole Kirk
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- SUSAR;
- Clinical Trials Directive;
- Europe;
- safety reporting;
66.Bioanalytical approaches, bioavailability assessment, and bioequivalence study for waiver drugs: In vivo and in vitro perspective

机译：豁免药物的生物分析方法，生物利用度评估和生物等效性研究：体内和体外观点
- 作者：Md. Faiyazuddin;Sarfaraz Ahmad;Gulam Mustafa;Farhan J. Ahmad;Faiyaz Shakeel
- 期刊名称：《Clinical research and regulatory affairs.》 | 2010年第4期
- Bioavailability;
- bioequivalence;
- waiver drugs;
- in vivo-in vitro correlation;
- cross-over design;
- balance incomplete-block designs;
67.Controlling type I errors for two-stage bioequivalence study designs

机译：控制两阶段生物等效性研究设计的I型错误
- 作者：Anders Fuglsang
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Bioequivalence;
- sequential design;
- type I error;
- trial simulation;
- ethics;
68.International regulatory review: Israel

机译：国际法规审查：以色列
- 作者：Sy Weinberg Qiu Fang
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Regulation;
- pharmaceutical;
- biomedical;
- medical device;
69.Comparative stability study of unit-dose repackaged furosemide tablets

机译：单位剂量速尿呋塞米片的比较稳定性研究
- 作者：E. B. Asafu-Adjaye;A. S. Carlin;E. H. Jefferson;A. R. Bryant
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Furosemide tablets;
- repackaging;
- unit-dose;
- potency;
- dissolution;
- water content;
- stability;
70.Comparison of pharmacokinetics of citalopram in healthy Asian Indian and Mexican volunteers

机译：西酞普兰在亚洲健康的印度裔和墨西哥志愿者中的药代动力学比较
- 作者：Manoj Singh Tomar;Anil Kumar Patni;Sunil Iyer;Arshad Hussain Khuroo
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Pharmacokinetics;
- citalopram;
- metabolism;
71.Renovation of ttie new medicine regulatory process

机译：创新新药监管程序
- 作者：Stanley T. Crooke
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
72.Regulatory recommendations for clopidogrel: Focus on validation of a reliable bioanalytical method and its application to a bioequivalence study

机译：氯吡格雷的法规建议：重点关注可靠的生物分析方法的验证及其在生物等效性研究中的应用
- 作者：Surajit Dey;Kirti Khwal;Shabana Nazarudheen;Onkar Singh
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Clopidogrel;
- clopidogrel acid;
- back conversion;
- method validation;
- bioequivalence;
73.Comparative study of anti-inflammatory activity of some branded generic and generic non-steroidal anti-inflammatory drugs

机译：某些品牌非专利和非甾体非甾体抗炎药抗炎活性的比较研究
- 作者：Vedavathi Thavva;Vijaya Ratna Jayanti;Joseph Weinberg
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Anti-inflammatory;
- analgesic;
- branded generic(B.G.);
- generics (G);
- non-steroidal anti-inflammatory drugs{NSAIDs);
74.Effects of pharmaceutical care interventions on blood pressure and medication adherence of patients with primary hypertension in China

机译：药物干预对中国原发性高血压患者血压和药物依从性的影响
- 作者：Jinping Wang;Jianlong Wu;Junfen Yang;Yihao Zhuang
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Primary hypertension;
- anti-hypertensive therapy;
- pharmaceutical care;
- medication adherence;
75.Use of computerized systems in clinical research: A regulatory perspective

机译：在临床研究中使用计算机系统：监管角度
- 作者：Pratik Thakkar;Balamuralidhara V.;T. M. Pramod Kumar;Ravi Valluru;Venkatesh M. P.
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
76.Retrospective analysis of the impact of post-approval drug research on utilization of new medicines in the US

机译：对美国批准后药物研究对新药利用的影响的回顾性分析
- 作者：Jean-Marc C. Ilacuslcr
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Post-approval research;
- retrospective study;
- drug utilization;
- publications;
77.Development and Mi validation of a quantitative assay for the determination of valsartan in human plasma and its application for bioequivalence study

机译：用于测定人血浆中缬沙坦的定量测定方法的开发和Mi验证及其在生物等效性研究中的应用
- 作者：Muzaffar Iqbal Khalid A. Al-Rashood
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
78.Pharmacokinetic and bioequivalence study of endogenous compound tretinoin 10 mg capsules in healthy volunteers by base line correction approach

机译：基线校正法研究内源性复合维甲酸10 mg胶囊在健康志愿者体内的药代动力学和生物等效性
- 作者：Nageshwar Rao Thudi;Vikesh Kumar Shrivastav;Tausif Monif
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Tretinoin;
- endogenous;
- bioequivalence;
- baseline adjustment;
- LC-MS/MS;
- retinoids;
79.A pharmacokinetic drug interaction study of ceftazidime with clavulanic acid in healthy male Indian subjects

机译：头孢他啶与克拉维酸在健康印度男性受试者中的药代动力学药物相互作用研究
- 作者：Manoj Singh Tomar;Anil Kumar Pami;Rachna Arora;Nageshvvar Rao
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Interaction;
- pharmacokinetics;
- ceftazidime;
- clavulanic acid;
- intravenous injection;
80.Safety and efficacy of long-term treatment with fluticasone propionate and salmeterol via DISKUS versus fluticasone propionate alone

机译：相比于单独使用丙酸氟替卡松，丙酸氟替卡松和沙美特罗通过DISKUS长期治疗的安全性和有效性
- 作者：Edward Kervvin;Charlene M. Prazma;Laura Sutton;David A. Stempel
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Fluticasone propionate;
- salmeterol;
- asthma attacks;
- exacerbations;
- long-term;
- asthma control;
81.Alzheimer s disease: Recent advances in diagnosis and overview of clinical research in newer treatments

机译：阿尔茨海默氏病：最新治疗方法的诊断和临床研究概述
- 作者：Shiva Naga Vara Prasad Bathula;Vijayshekar Dustakar
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
- Alzheimer's;
- diagnosis;
- clinical research;
82.Regulation of laboratory-developed diagnostic assays: Where we are

机译：规范实验室开发的诊断检测方法：我们在哪里
- 作者：Navneeta Bansal
- 期刊名称：《Clinical research and regulatory affairs.》 | 2011年第4期
83.Obituary for Sanford Weinberg (1950-2011)

机译：桑福德·温伯格的告（1950-2011）
- 作者：Janine Cahill
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
84.Editorial

机译：社论
- 作者：Krishna Devarakonda
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
85.Comparative bioavailability study of capecitabine tablets of 500 mg in metastatic breast cancer and colorectal cancer patients under fed condition

机译：500 mg卡培他滨片在进食条件下对转移性乳腺癌和结直肠癌患者的生物利用度比较研究
- 作者：Chaitanya Gadiko;Sudhakar K. Tippabhotla;Satyanarayana Thota;Ramakrishna Battula
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
- Bioequivalence;
- pharmacokinetics;
- capecitabine;
- metastatic breast cancer;
- colorectal cancer;
86.Bioanalytical method development and validation using incurred samples: Quantitative estimation of metformin in human K3EDTA plasma by LC-MS/MS

机译：使用产生的样品进行生物分析方法的开发和验证：通过LC-MS / MS定量估算人K3EDTA血浆中的二甲双胍
- 作者：Sanjay Gurule;Dipanjan Goswami;Arabinda Saha;Yogesh Modhave;Arshad Khuroo
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
87.Pharmacovigilance regulations in India: A Step forward

机译：印度的药物警戒法规：前进的一步
- 作者：Shilpi Khattri;Balamuralidhara V.;Pramod Kumar T. M.;Ravi Vallum;Venkatesh M. P.
- 期刊名称：《Clinical research and regulatory affairs.》 | 2012年第4期
88.Current regulatory challenges and approaches in the registration of herbal drugs in Europe

机译：目前欧洲草药注册中的监管挑战和方法
- 作者：Nitin Verma
- 期刊名称：《Clinical research and regulatory affairs.》 | 2016年第4期
- Herbal drug;
- efficacy;
- regulations;
- practices;
- quality;
- safety;
89.An assessment of quality of life in ambulatory schizophrenics: World health organization quality of life assessment scale (whoqol-100) concepts quality of life of ambulatory schizophrenics

机译：An assessment of quality of life in ambulatory schizophrenics: World health organization quality of life assessment scale (whoqol-100) concepts quality of life of ambulatory schizophrenics
- 作者：Pippalla RS;Chaar MDC
- 期刊名称：《clinical research and regulatory affairs》 | 2001年第2期
90.Injury-induced CNS plasticity: A sexually dimorphic response in Hippocampal sprouting

机译：Injury-induced CNS plasticity: A sexually dimorphic response in Hippocampal sprouting
- 作者：Morse JK
- 期刊名称：《clinical research and regulatory affairs》 | 2001年第2期
91.Evaluation of proposed otc switch for lovastatin

机译：Evaluation of proposed otc switch for lovastatin
- 作者：Achanta AS;Rhodes CT
- 期刊名称：《clinical research and regulatory affairs》 | 2001年第2期
92.Some implications of the phenylpropanolamine problem

机译：Some implications of the phenylpropanolamine problem
- 作者：Rhodes CT
- 期刊名称：《clinical research and regulatory affairs》 | 2001年第2期
- INTRACEREBRAL HEMORRHAGE;
- HYPERTENSION;
- CAFFEINE;
93.Trazodone and priapism - Implications for responses to adverse events

机译：Trazodone and priapism - Implications for responses to adverse events
- 作者：Rhodes CT
- 期刊名称：《clinical research and regulatory affairs》 | 2001年第2期
- THERAPY;

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