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1. Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets

by Sadia Amin | Dr. Sualeha Riffat | Prof. Dr. Muhammad Ashraf.

Material type: book Book; Format: print ; Nature of contents: biography; Literary form: Publisher: 2011Dissertation note: Objective of this bioequivalence study was to compare pharmacokinetic parameters and to evaluate bioequivalence of two generic drug products. A multinational company brand was compared with locally manufacture brand. It was a randomized, single dose, two-period crossover study in which 12 volunteers were participated with the age limit of 18-30yrs. These volunteers were selected according to different inclusion and exclusion criteria and the study was conducted with one week washout period. Each volunteer was one tablet of montelukast (reference or test) lOmg. 14 blood samples of 4-Sml collected at predefined time intervals i.e, 0, O.S, 1.0, 1.S, 2.0, 2.5, 3.0, 3.S, 4.0, 6.0, 8.0, 10, 12 and 24 hours .. Heparinized vacuette were used for collection of blood samples. After sampling, blood samples were centrifuged immediately to separate plasma and stored at -80°C till analyzed. Plasma montelukast concentration was evaluated by using reverse phase - high performance liquid chromatography (RP-HPLC) method. Potassium dihydrogen phosphate O.OSM at pH 3.5 with orthophosphoric acid in combination to acetonitrile (20:80) was used as mobile phase. The wavelength of detector was set at 34Snm and flow rate was set to 2.0ml per min. Drug from plasma was extracted by de-proteinizing the plasma with acetonitrile. 70 III injection volume was given to HPLC for analysis. For comparing the pharmacokinetic parameters two compartment analysis was used and pair t-test was applied. Non compartmental analysis was used for evaluating pharmacokinetic parameters to evaluate the both drugs were bioequivalent or not. 3 major parameters of bioequivalence Cmax, AVC O-inf and AVC O-t were evaluated and they did not show significant difference in between two formulations. Also the 90% confidence interval values were within the limit. So, it was concluded that both the test and reference drug were bioequivalent and test drug could be used interchangeably with the reference drug. Availability: Items available for loan: UVAS Library [Call number: 1311,T] (1).

2. Bioequivalence Study Of Deferiprone In Healthy Volunteers

by Naila Waheed | Dr. Sualeha Riffat | Prof. Dr. Muhammad Ashraf.

Material type: book Book; Format: print ; Literary form: not fiction Publisher: 2011Dissertation note: The study was conducted with the aim of evaluating bioequivalence, relative silability and efficacy of deferiprone manufactured locally (Ferinil, Global aceutical, Pakistan) with a reference drug (Ferriprox, ApoPharma, Canada) in healthy volunteers. It was a randomized crossover study enrolling 12 volunteers within age limit g·55yrs and meeting the inclusion and exclusion criteria of the study, Each volunteer was administered two tablets of deferiprone 500mg of both reference and test drug with a two- washout period. Blood samples of about 5ml was collected at 0, 0.25, 0.5, 0.75, 1, 1.5, 5,4, 6, 8, 12 hour at predetermined time intervals and one sample was taken as control giving first dose to volunteers. Heparinized vacuette was used for collection of blood les. After sampling, blood samples was centrifuged at approximately 3000 rpm for 10 les and then stored at -80°C till analyzed. Plasma deferiprone levels were analyzed using led High pressure liquid chromatography (HPLC) method. Pharmacokinetic parameters calculated from plasma concentration time curve non-compartmentally and two- artmental. After logarithmic transformation of data statistical comparisons of Cmax, (0-1), AUC(o.oo) was calculated and appropriate statistical method was used for calculation. mean relative bioavailability was 104% and was proved to be bioavailable. The Cmax (mean ±SD) for reference and test drug was 12.68 ± 4.91 and 14.41 ± 5.04 ug/ml, ctively while average ± SD of AUCO-t and AUCO-inf of test and reference drug was 40.49 6,05 and 42.84 ± 18.47 ugh/ml and 38.63 ± 13.65 and 40.75 ± 14.17 ugh/ml. Average (test/reference) of Cmax 90% CI was 0.9876-1.3125. Average ratio (test/reference) of Co.190% CI was 0.9737-1.1150, and of AUCo-inf 90% CI was 0.9542-1.1343. Therefore both test and reference drug was fairly tolerated by volunteers and no adverse event was detected. Hence, the average ratio of 90% confidence interval of AUCo-t and AUCO-inf was 0.9737-1.1150 and 0.9542-1.1343 that lie within the acceptable limit of (0.80 - 1.25) for bioequivalence acceptance. Effectiveness of deferiprone depends on AUC instead of Cmax therefore the average ratio of 90% confidence interval of Cmax was 0.9876-1.3125 that lie with the acceptable limit of WHO bioequivalence acceptance (0.75 - 1.33). ANOVA show no significant variations among drug, period and sequence effect. Therefore, it was concluded that Ferriprox was proved to be bioequivalent in healthy male Pakistani volunleers. Availability: Items available for loan: UVAS Library [Call number: 1327,T] (1).

3. Comparative Pharmacokinetics Of Silymarin In Healthy Male And Female Volunteers

by Farah Abid | Prof.Dr.Muhammad Ashraf | Dr. Mateen | Dr. Sualeha Riffat.

Material type: book Book; Format: print ; Nature of contents: biography; Literary form: Publisher: 2011Dissertation note: The study was designed to compare the pharmacokinetic parameters of Silymarin in 8 healthy male and 8 healthy female volunteers. Only those healthy volunteers were selected who were of age between 18-45 years, not having any disease. Female's volunteers were also of age of 18-45 years and also who were not pregnant and also not suffering from any disease. Written consent form were taken from the volunteer and they were thoroughly inform about the study and objectives of study ,frequency of blood sampling, and any other side effects linked to the drug which they might having during the study. Volunteers were divided into two groups A and B respectively. Both groups were given silymarin 200mg dose per oral to each individua1.5ml of blood samples were drawn after different time interval .5 ,1,2,3,5,8 and 12 hr from the vein through 5ml BD syringes of 22 gauge needle after oral administration of silymarin. Plasma were separated by centrifugation at 5000 RPM and stored at -40 C till analysis. Silymarin concentration in plasma was determined by using HPLC method. All pharmacokinetics parameter were determined by entering the plasma concentration time data in software APO pharmacological analysis .Then pharmacological parameters in healthy male and healthy females were compared. Result showed that pharmacokinetic parameters are significant & those parameters were AVC, Tmax, t1l2 & CI. This result showed that there is a significant relationship between healthy male & female. Availability: Items available for loan: UVAS Library [Call number: 1329,T] (1).

4. Isolation And Characterization Of Collagen Type Ii From Poultry Trachea

by Sidra Ashraf | Dr. Abu Saeed Hashmi | Dr. Sualeha Riffat | Zahid Mushtaq.

Material type: book Book; Format: print Publisher: 2011Dissertation note: This project was designed to use poultry waste to isolate and characterize collagen type II from its trachea. Collagen type II is being used along with condroitin sulfate and glucosamine for the treatment of osteoarthritis and is also available as a neutraceutical product in the market. For project purpose, trachea of slaughtered broiler birds were collected from the market and after removing adhering tissue and debris, it was then washed thoroughly first with distilled water and then with deionized water. Tracheal cartilage was then cut into small pieces and defattened with chloroform: methanol (2: 1 v/v) solution. After this, the cut pieces were properly cleaned with deionized water. 0.5% Pepsin solution in 0.5 M acetic acid was prepared. Cartilage was then hydrolyzed by the already prepared 0.5 % pepsin (in 0.5 M acetic acid) at 4 ° C for 48 hours. The extract was then separated from the tracheal pieces and the viscous solution obtained was centrifuged at 12000 rpm for 1 hr at 4 "c. Now the collagen was expected to be in the supernatant which was salted out by adding NaCI to a final concentration of 2.5M and kept for almost 12-16 hrs. This collagen was again centrifuged at 12000 rpm for 1 hr at 4 C. The obtained collagen pallet was redissolved in 0.5 M acetic acid and then it was dialyzed against 0.1 M acetic acid followed by dialysis with distilled water. The sample after dialysis was put in petri dishes and kept in freezer for overnight to let it be prepared for lyophilization. The frozen collagen sample was then lyophilized. After lyophilization, the sample gave an appearance of a white mesh. This sample was reconstituted in PBS with pH 8 to run it on SDS-PAGE. The procedure of SDS-PAGE in non reducing conditions was adopted for the characterization of collagen type II in the sample. The description of results of SDS-PAGE is given below: Lane M contains protein markers of different molecular weight. Lane 1, 2 and 3 contains samples at different steps of the whole procedure showing clear bands of collagen type II. Lane 4 contains lyophilized sample of collagen type II showing the thickest band (alpha chain of collagen type II). In this research, poultry waste has been used for making health improving product. As in our country poultry is used in bulk quantity so if its waste might be used in any medicinal product then it might not only be useful but also economical for such a developing country as ours. Another thing is that as this collagen Type II has been extracted from poultry trachea, it shows that tracheal cartilage is a rich source of such collagen type. Collagen Type II is used in the cure of arthritis especially rheumatoid arthritis so through this research, it has been made clear that poultry waste can be utilized in a positive way in medicinal industry and also that collagen Type II acts as an effective neutraceutical. Availability: Items available for loan: UVAS Library [Call number: 1330,T] (1).

5. Pharmacokinetics Of Carvedilol In Dogs After Oral Administration

by Khurram Wajih Mahmood | Ms. Huma Rasheed | Dr. Mateen | Dr. Sualeha Riffat.

Material type: book Book; Format: print ; Literary form: not fiction Publisher: 2011Dissertation note: Carvedilol, is a class-II, non-biowaivered drug, with low solubility. It is a candidate for several in-vivo studies including bioavailability and bioequivalence of generic versus standard, and also for testing performance of modified release products. Single dose pharmacokinetic study was performed on 12 healthy dogs using 25mg Carvedilol tablets. The objective of this study was to perform pharmacokinetic and biopharmaceutic study in the dog model for Carvedilol. The animals were selected after screening by veterinary practitioner. Blood samples were collected after 15min, 30min, 1 hr, 1.5 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs and 24 hrs via an in-dwelling catheter from the cephalic vein of the animals along with one base line sample taken before drug administration. The plasma samples obtained by centrifugation were analyzed by HPLC quantitative method after checking the reproducibility and linearity of the standard curve using the standards prepared in dog plasma. Pharmacokinetic parameters were calculated by using APO software, and using appropriate compartmental pharmacokinetic model. The data derived from this study was analyzed using descriptive statistics and the observed results were compared with the published literature. The pharmacokinetic parameters investigated show that peak plasma concentration was 72.33±32.84 ng/ml, elimination half life of 1.84±2.42 hrs, Mean Residence Time was 2.98±0.96hrs, Volume of distribution of 0.57±0.6 l/kg and time to peak plasma concentration of 1.77±0.31hrs. The study defends the older proposition by pharmacokineticists that the Carvedilol shows unpredictable absorption kinetics in dogs and a few of the parameters also relate with the published finding on the Carvedilol pharmacokinetics in human. The delay in absorption and significant lag time of 1.23hrs was consistent in all subjects. The study elaborated the prospects of the possibility of using animal studies to achieve predictable pharmacokinetics of the drugs without involving human subjects. Availability: Items available for loan: UVAS Library [Call number: 1423,T] (1).

6. Comparison Of Dsingle-Dose Pharmacokinetics Of Candesartan Cilexetil In Healthy Male & Female

by Hafiz Awais Nawaz | Muhammad Irfan Masood | Dr. Mateen | Dr. Sualeha Riffat.

Material type: book Book; Format: print ; Literary form: not fiction Publisher: 2012Dissertation note: This study was designed to compare the pharmacokinetic parameters of Candesartan in 8 healthy male and female volunteers. The study was conducted in eight healthy male volunteers and eight healthy female volunteers. Only those male volunteers were selected who aged between 18-30 years, not suffering from any disease. Female volunteers were also between age of 18-30 years, who were not pregnant and not suffering from any disease. Written consent was taken from them and they were informed about objectives of the study, frequency of blood sampling, and possible side effects of drug which they might face during the study. The male volunteers were considered as group A and healthy female volunteers were considered as group B. Both groups were administered Candesartan 16mg tablet orally to each individual. 5ml Blood samples were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 & 72 hr after the oral drug administration from vein through 5ml B.D syringe of 22guage needle. Plasma was separated by centrifugation at 5000 RPM and stored at -80ºC till analysis. Candesartan concentrations in plasma were measured by HPLC method. All pharmacokinetic parameters were calculated by entering plasma concentration-time data in software APO pharmacological analysis MW/PHARM version 3.02 by assuming bio-availability of Candesartan after oral administration as 1. Pharmacokinetic parameters of Candesartan in healthy male and female volunteers were compared. Data was analyzed by unpaired t-test and it was observed that there is significant difference in AUC of Candesartan in healthy male and female volunteers after oral administration without any effect in Cmax, Tmax, volume of distribution, absorption rate constant or elimination half life. In general, candesartan produced comparable results in healthy male and female volunteers so there is no need of any dose adjustment during therapy in both genders. Availability: Items available for loan: UVAS Library [Call number: 1442,T] (1).

7. Bioequivalence Study Of Atorvastatin Tablets In Human Volunteers

by Asif Ali Bokhari | Dr. Sualeha Riffat | Prpf. Dr. Muhammad Ashraf.

Material type: book Book; Format: print Publisher: 2012Dissertation note: Main purpose of this clinical trail was to evaluate bioequivalence parameters of two generic drug products. It was a randomized, single dose, two-period crossover trial. Study was done on 12 volunteers with the age limit of 18-45yrs. Inclusion and exclusion criteria was used for volunteers selection and the study conducted with two week washout period. Each volunteer received one tablet of atorvastatin (reference or test) 10mg. Almost 13 blood samples of 5ml were collected at predefined time intervals. Blood samples were collected in heparinized vacuette. Blood was centrifuged after sampling and stored at -80°C till analysis. Serum atorvastatin levels were examined by using high performance liquid chromatography (HPLC) method mobile phase was a mixture of Sodium di-hydrogen phosphate buffer and acetonitrile 65:35 v/v pumped at flow rate of 1ml/min at a wavelength of 260nm. Two compartmental analysis was used for evaluating bioequivalence parameters to evaluate the both drugs were bioequivalent or not .2 major parameters of bioequivalencepeak plasma concentration Cmax and area under the curve AUC 0-t were evaluated. By statistical analysis, 90% confidence interval for area under the curve AUC 0-t was found to be 0.5972 - 1.7093, it was not within the range (0.80 - 1.25) proving an in equivalence between the two products so it shows that area under the curve AUC 0-t for both drugs is not equivalent. By statistical analysis, 90% confidence interval for peak plasma concentration Cmax found to be 0.3840 - 3.6638., it was not within the range (0.80 - 1.25). So it is evident that peak plasma concentration Cmax for both drugs is not equivalent. So, it was concluded that both of the drugs were not bioequivalent. From the given data, it is concluded that both the drugs produced uncomparable results. So it can be concluded that Lipiget cannot be used in replacement of Lipitor. Availability: Items available for loan: UVAS Library [Call number: 1480,T] (1).

8. Assesment Of Postprandial Glycemic Response In Healthy Human With Respect To Some Promising Indigenous Mango Varieties Of Pakistan

by Afrah Jabeen (2014-VA-911) | Mr. Haroon Jamshaid Qazi | Dr. Sanaullah Iqbal | Dr. Sualeha Riffat.

Material type: book Book; Literary form: not fiction Publisher: 2016Dissertation note: Carbohydrates intake result in elevation of BGL. GI is a simple tool to select right carbohydrate foods while GL determines the overall effect of that food on human health. High GI/GL diets are directly associated with progression of diabetes type 2. Mango is ranked among medium glycemic index fruit with GI (51-55) and nutritionally it is rich in dietary fiber. Different mango types have different nutritional composition so it was very necessary to estimate postprandial glycemic response of various mango types to determine the possible positive impact of all varieties on overall human health. Samples of six mango varieties were evaluated for various physico-chemical testing. About 50-gram available carbohydrate from each source i.e. glucose and six mango cultivars were provided to each study person. Later on, post prandial blood glucose of all 10 individuals with a time interval of 15 minutes was determined by finger-prick method up to 120 minutes. ANOVA was used to analyze all assessed attributes statistically. Means were compared through Duncan’s multiple range test for significance. Significance level was defined as p≤0.0.5 SPSS version 20 was used for all statistical analysis. Desi variety among all studied mango types reflected low GI and GL value. Availability: Items available for loan: UVAS Library [Call number: 2697-T] (1).



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