Clinical Research and Regulatory Affairs最新文献_第9页

Floating drug delivery system of verapamil hydrochloride using karaya gum and HPMC 卡拉亚胶与HPMC联合制备盐酸维拉帕米漂浮给药系统

Clinical Research and Regulatory Affairs Pub Date : 2010-02-26 DOI: 10.3109/10601331003604762

H. Gangadharappa, M. Rahamath-Ulla, T. M. Pramod-Kumar, F. Shakeel

引用次数: 21

A simple and sensitive validated HPLC method for quantitative determination of cisplatin in human plasma 一种简便、灵敏的高效液相色谱法测定人血浆中顺铂含量

Clinical Research and Regulatory Affairs Pub Date : 2010-02-26 DOI: 10.3109/10601330903490462

K. Kaushik, V. Sripuram, S. Bedada, N. Reddy, G. Priyadarshini, K. Devarakonda

{"title":"A simple and sensitive validated HPLC method for quantitative determination of cisplatin in human plasma","authors":"K. Kaushik, V. Sripuram, S. Bedada, N. Reddy, G. Priyadarshini, K. Devarakonda","doi":"10.3109/10601330903490462","DOIUrl":"https://doi.org/10.3109/10601330903490462","url":null,"abstract":"Cisplatin is an anti-tumor agent widely employed in cancer chemotherapy. A specific and selective method for the quantitative determination of cisplatin in human plasma and its applications to pharmacokinetic investigations is described. One simple ethanol-induced protein precipitation step followed by simple liquid–liquid extraction with chloroform is the only requirement as sample treatment. The resulting solution is injected into a Wakosil II (5 μm, 250 cm × 4.6 mm I.D.) analytical column. The mobile phase consisted of methanol:water:acetonitrile (40:30:30 v/v/v). The limit of quantitation was 1 μg/mL. The method showed good recovery (93.95%) and within batch recovery was 91.59–97.00%. At all levels intra- and inter-assay precision was lower than 7 and 10%, respectively. The intra- and inter-assay accuracy ranged from −2.7 to 2% and from −3.1 to 4.0%, respectively. The selectivity (discrimination between the parent drug and platinum containing species such as cisplatin metabolites), simplicity and speed of this assay for free cisplatin quantitation should facilitate pharmacokinetic investigations and therapeutic drug monitoring.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"3 1","pages":"1 - 6"},"PeriodicalIF":0.0,"publicationDate":"2010-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73315701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 16

Bioequivalence model for evaluation of Losartan in human plasma with special reference to drug–metabolite ratio 评价氯沙坦在人血浆中的生物等效性模型，特别参考药物代谢比

Clinical Research and Regulatory Affairs Pub Date : 2009-11-05 DOI: 10.3109/10601330903271263

D. Goswami, S. Gurule, A. Khuroo, T. Monif

引用次数: 3

Comparison of effect of fasting and of five different diets on the bioavailability of single oral dose of clarithromycin 500 mg extended release tablet 空腹与5种不同饮食对克拉霉素500 mg缓释片单次口服生物利用度的影响比较

Clinical Research and Regulatory Affairs Pub Date : 2009-11-05 DOI: 10.3109/10601330903252198

S. Gurule, T. Monif, P. Verma, A. Khuroo

引用次数: 1

Population pharmacokinetics of doxorubicin in Indian cancer patients using NONMEM 用NONMEM分析阿霉素在印度癌症患者中的群体药代动力学

Clinical Research and Regulatory Affairs Pub Date : 2009-11-05 DOI: 10.3109/10601330903252214

Vijay Kumar, Harish K. Kaushik, Satish B. Kumar, N. Reddy, Narasimha Y. Reddy, T. Kumaraswamy, Praneet Kumar, K. Devarakonda

{"title":"Population pharmacokinetics of doxorubicin in Indian cancer patients using NONMEM","authors":"Vijay Kumar, Harish K. Kaushik, Satish B. Kumar, N. Reddy, Narasimha Y. Reddy, T. Kumaraswamy, Praneet Kumar, K. Devarakonda","doi":"10.3109/10601330903252214","DOIUrl":"https://doi.org/10.3109/10601330903252214","url":null,"abstract":"The population pharmacokinetics of doxorubicin were evaluated based on a mixed-effect model using the NONMEM (VI) program. Doxorubicin in plasma was measured using high-performance liquid chromatography. Plasma concentration measurements (85 plasma samples) of doxorubicin from 28 patients with cancer receiving doxorubicin (with other co-medication) ranging from 20–120 mg by infusion over 1–2 h were analyzed according to a two-compartment model both in FO and FOCE methods. Additive proportional error model was used to describe inter-individual and residual variability. The influence of covariates such as age, body surface area, gender, and clinical laboratory values (SGOT, SGPT) on total body clearance (CL) and volume of distribution (Vd) were examined. No covariate was found to affect the CL and Vd of unchanged doxorubicin. The CL and Vd estimated by FO method were 1.42 L/h and 51.1 L, respectively, and FOCE method are 1.43 L/h and 51.4 L, respectively. The inter-individual variability for CL and Vd and residual variability were 45.8%, 36%, and 12.6%, respectively. The population means and inter-individual and residual variability of pharmacokinetics of doxorubicin were evaluated using the NONMEM program. The results of this study show that the population pharmacokinetic approach could be useful to manage doxorubicin cardio toxicity using sparse data in a clinical setting.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"13 1","pages":"100 - 93"},"PeriodicalIF":0.0,"publicationDate":"2009-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82282396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Population pharmacokinetics of cisplatin in Asian Indian cancer patients 顺铂在亚洲印度癌症患者中的人群药代动力学

Clinical Research and Regulatory Affairs Pub Date : 2009-11-05 DOI: 10.3109/10601330903252206

Harish K. Kaushik, Vijay Kumar, Satish B. Kumar, N. Reddy, V. K. Raghavaiah, K. Devarakonda

{"title":"Population pharmacokinetics of cisplatin in Asian Indian cancer patients","authors":"Harish K. Kaushik, Vijay Kumar, Satish B. Kumar, N. Reddy, V. K. Raghavaiah, K. Devarakonda","doi":"10.3109/10601330903252206","DOIUrl":"https://doi.org/10.3109/10601330903252206","url":null,"abstract":"The aim of this study was to describe population pharmacokinetics of cisplatin in an Indian cancer population. Dosage adjustment based on individual pharmacokinetic parameters is of considerable importance for effective and safe use of drugs. Extensive work on cisplatin and other was carried out in different cancer patient populations, but no data are available in Indian cancer patients. In the present study 154 steady state concentrations of cisplatin were analyzed from 46 patients. Pharmacostatistical work was done by using NONMEM. The covariates evaluated in this study were age, body weight, height, sex, and creatinine clearance. The model found to best describe the data following the FO and FOCE method was: Clearance (CL) = θ1*(CLCR/74.92) *EXP (η1) and Volume (V) = {θ2 *(AGE/52.3) + θ3*(BSA/1.55)}*EXP (η2). The final model estimates of CL and V estimated by FO method were 3.02 L/h and 2.72 L, respectively, and by FOCE method were 3.39 L/h and 4.48 L, respectively. These parameters are utilized for individualizing the loading and maintenance doses in pediatric patients.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"10 1","pages":"84 - 92"},"PeriodicalIF":0.0,"publicationDate":"2009-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89547033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Development and characterization of a carvedilol-loaded self-microemulsifying delivery system 卡维地洛自微乳化输送系统的研制与表征

Clinical Research and Regulatory Affairs Pub Date : 2009-08-21 DOI: 10.1080/10601330903143942

S. Singh, P. Verma, B. Razdan

{"title":"Development and characterization of a carvedilol-loaded self-microemulsifying delivery system","authors":"S. Singh, P. Verma, B. Razdan","doi":"10.1080/10601330903143942","DOIUrl":"https://doi.org/10.1080/10601330903143942","url":null,"abstract":"The objective of the work was to develop, optimize, and evaluate a self-microemulsifying drug delivery system of the poorly water-soluble drug, carvedilol. Solubility of carvedilol was determined in various vehicles. Ternary and pseudo-ternary phase diagrams were constructed to indentify the efficient self-emulsification region using oils, surfactants, and co-surfactants in aqueous environment. Optimized formulations were assessed for drug content, spectroscopic clarity, emulsification time, contact angle, zeta potential, particle size, and dissolution studies. Zeta potential was measured in the absence and presence of oleylamine, a positive charge inducer. On the basis of similarity and dissimilarity of particle size distribution, formulations were characterized using PCA and AHCA, a multivariate statistical analysis. Decrease in t50% and increase in DE attributed to small globule size and eventually higher surface area. The relevance of differences in t50% and DE was evaluated statistically by two-way ANOVA. DRIFTS, DSC, and X-RD studies indicated no incompatibility between drug, oil, and surfactants. The results of this study indicate that the SMEDD formulations of carvedilol owing to nanosize have the potential to enhance its absorption, without interaction or incompatibility between the ingredients.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"28 1","pages":"50 - 64"},"PeriodicalIF":0.0,"publicationDate":"2009-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82198287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 14

Does linezolid-induced tongue discoloration need further investigation? 利奈唑胺引起的舌头变色是否需要进一步调查?

Clinical Research and Regulatory Affairs Pub Date : 2009-08-21 DOI: 10.1080/10601330903200692

T. Eid, Patrick DiTullio, Sachin A. Shah

引用次数: 0

Approaches and issues towards development of efficient mucosal vaccines against pneumonia 开发有效的肺炎粘膜疫苗的途径和问题

Clinical Research and Regulatory Affairs Pub Date : 2009-08-21 DOI: 10.1080/10601330903012436

Dilip Devineni, Simon A Paulos, Ruhi V. Ubale, B. Rayaprolu, R. Palaniappan

引用次数: 0

Liquid chromatographic tandem mass spectrometric validated method for pharmacokinetic estimation of flecainide in human plasma 液相色谱串联质谱法测定人血浆中氟克林胺的药动学

Clinical Research and Regulatory Affairs Pub Date : 2009-06-01 DOI: 10.1080/10601330902919797

D. Goswami, Ajay Kumar, A. Khuroo, T. Monif, S. Gurule, N. Thudi, V. Shrivastav, S. Dubey

{"title":"Liquid chromatographic tandem mass spectrometric validated method for pharmacokinetic estimation of flecainide in human plasma","authors":"D. Goswami, Ajay Kumar, A. Khuroo, T. Monif, S. Gurule, N. Thudi, V. Shrivastav, S. Dubey","doi":"10.1080/10601330902919797","DOIUrl":"https://doi.org/10.1080/10601330902919797","url":null,"abstract":"A sensitive high throughput LC/MS/MS method fully validated as per USFDA guidelines is described for pharmacokinetic estimation of flecainide in human plasma using loperamide as the internal standard. Plasma samples were monitored by cation exchange solid phase extraction achieving 78.6% extraction efficiency (mean recovery) followed by chromatographic separation on a PurospherStar RP-18e column. Detection was carried out on an API positive ESI by MRM transitions m/z 415.2/301.1 and 477.3/266.3 for flecainide and loperamide respectively. High sensitivity of 1.17ng/ml, dynamic linearity of 1.17–396.75 ng/ml and short run time within 3 minutes are other interesting aspects of this new bioanalytical method. This method was successfully applied to a pharmacokinetic study with 100mg tablet flecainide administered in Indian population for the first time. A randomized, single dose, two sequence, cross over study design was used to evaluate bioequivalence on 40 healthy male fasted volunteers and blood samples were collected up to 96 hours post dose. Noncompartmental pharmacokinetic analysis was used to evaluate AUC0-t, AUC0-inf, Cmax, Tmax, T1/2 and λz scaled on a 90% confidence interval approach. Average bioequivalence results showed ratios of least square means and its 90% CIs for ln-transformed Cmax, AUC0-t and AUC0-inf for flecainide were 99.99 (95.21–104.99) %, 98.27(93.89–102.86)% and 98.08(93.68–102.68)% respectively. Both the test and reference products were closely comparable in terms of rate and extent to which the drugs access the systemic circulation.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"29 1","pages":"24 - 36"},"PeriodicalIF":0.0,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83501229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1