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PubMed | Soonchunhyang University, Lambda Therapeutic, Intas Pharmaceuticals Ltd., King Saud University and 2 more.
Type: Journal Article | Journal: Molecules (Basel, Switzerland) | Year: 2016

Quantitative targeted proteomics based approaches deploy state-of-the-art Liquid chromatography tandem mass spectrometry LC-MS technologies and are evolving as a complementary technique to standard ligand-binding based assays. Advancements in MS technology, which have augmented the specificity, selectivity and sensitivity limits of detection and freedom from antibody generation, have made it amicable towards various clinical applications. In our current work, a surrogate peptide based quantitative proteomics assessment is performed by selecting specific signature peptides from the complementary determining region CDR region of trastuzumab (Herclon


The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this years closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industrys best practices and the conclusions from the discussion of these topics is included in this meeting report.


PubMed | Shah Hospital, Lambda Therapeutic and Sheth V S Hospital
Type: Journal Article | Journal: Indian journal of orthopaedics | Year: 2016

There is paucity of literature about antibiotic uptake in bone grafts soaked in antibiotic solutions at room temperature in the operation theatre. We hypothesized that if bone grafts are dipped in different strengths of antibiotic solutions for sufficient period, their utilization at the target site helps in localized release of antibiotics in adequate inhibitory concentration to achieve the bacterial regression. The purpose of the study was to find out: (1) Optimum duration, strength, and volume of antibiotic solution required for dipping bone grafts at room temperature prior to the use. (2) What could be the clinical implications of the results obtained?Bone shavings from total knee replacements were processed, frozen and transported to bio-analytical laboratory. The bone fragments were then impregnated with different volume and different strength of gentamicin and vancomycin over different time periods. The soaked bone samples underwent further processing for analysis on liquid chromatography tandem mass spectrometry (LC-MS/MS) system.After series of bio-analytical estimation for the soaked drug concentration among bone fragments; the optimal estimation was found with 0.2 mL of 2% strength of gentamicin and vancomycin, the optimal time was found with soakage up to 30 min. These estimated values of soaked antibiotics were five 5 times higher than required minimal inhibitory concentration (MIC) values for bacterial regression.Use of antibiotic soaked bone allografts at target sites as potential drug carrier can be a hassle- free yet cost- effective and safe process for achieving maximum bacterial regression.


Shah K.N.,Lambda Therapeutic | Patel S.S.,Nirma University
Pharmaceutical Biology | Year: 2015

Context: Quercetin, a flavonoid, has been tried in traditional medicine for treating many disorders and reported to have inhibitory action on PI3 kinase. Objective: This study investigates the effect of quercetin on testosterone propionate induced polycystic ovary syndrome (PCOS) model, which shows both metabolic and endocrine features of PCOS. Materials and methods: Female pre-pubertal Sprague–Dawley rats were randomly divided into four groups: normal control, PCOS control, quercetin, and metformin treated. PCOS was induced by testosterone propionate (10 mg/kg, s.c.) and treatments were carried out orally at the dose of 150 mg/kg from the 6th week. At the 6th and 10th week, blood was collected to investigate metabolic indices, and reproductive biochemical parameters including morphology of ovary, uterus, and estrous cyclicity were assessed. The ovaries were processed to determine CYP17A1 gene expression. Results: The treatment with quercetin did not modify body weight gain but uterine (296.7 ± 5.11 versus 263.0 ± 8.60 mg) and ovary weights (49.5 ± 1.93 versus 37.8 ± 3.43 mg) were found to be decreased significantly (p <0.05) as compared with the PCOS control group. The PCOS control group showed hyperinsulinemia, hyperandrogenemia, and dyslipidemia. Treatment with quercetin showed statistically significant (p <0.01) improvement in insulin (12.46 ± 0.3 versus 10.0 ± 0.28 μU/ml), testosterone (0.65 ± 0.02 versus 0.29 ± 0.02 μU/ml), luteinising hormone (20.6 ± 0.28 versus 15.1 ± 0.36 U/ml), and lipid profile. Histological examination of ovary and uterus confirmed the disease occurrence and remission state in the diseased and treated groups, respectively. Quercetin also demonstrated PI3 kinase inhibition in a docking study and decreased CYP17A1 gene expression. Discussion and conclusion: Thus, we can conclude that quercetin may have beneficial effect in PCOS by virtue of inhibition of PI3K which attributes to a decrease in the expression of CYP17A1 gene, having a key role in steroidogenesis. © 2015 Taylor & Francis


Kale P.,Lambda Therapeutic | Kale P.,Gujarat Forensic Sciences University | Agrawal Y.K.,Gujarat Forensic Sciences University
Frontiers in Pharmacology | Year: 2015

Objective: To assess the bioequivalence of single dose trazodone hydrochloride USP 100 mg tablets administered as an oral dose under fed condition. Methods:This study was an open-label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover bioequivalence study in healthy, adult, human subjects under fed conditions. After an overnight fast of at least 10 h, the subjects were served a high fat and high calorie vegetarian breakfast, which they were required to consume within 30 min. A single oral dose (100 mg) of either the test or the reference product was administered to the subjects. The primary pharmacokinetic parameters, maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) from time zero to last measurable concentration (AUC0-t) and extrapolated to infinity (AUC0-∞) were compared by an analysis of variance using log-transformed data. Bioequivalence was concluded if the 90% confidence intervals (CIs) of the adjusted geometric mean (gMean) ratios for Cmax and AUC were within the predetermined range of 80-125%, in accordance with regulatory requirements. Results:For the test formulation, the trazodone gMean Cmax was 1480.9 ng/mL (vs. 1520.2 ng/mL for reference), AUC0-t was 18193.0 ng·h/mL (vs. 18209.8 ng·h/mL) and AUC0-∞ was 19346.3 ng·h/mL (vs. 19393.4 ng·h/mL). The 90% CIs for the ratio (test/reference) were 93.0-102.0% for Cmax, 96.7-103.2% for AUC0-t and 96.1-103.5% for AUC0-∞. There were no deaths or serious adverse events during the conduct of the study. Conclusion:Test product when compared with the Reference product meets the bioequivalence criteria with respect to the extent of absorption of trazodone under fed condition. © 2015 Kale and Agrawal.


Ahmad A.,Jina Pharmaceuticals Inc. | Shahabuddin S.,Jina Pharmaceuticals Inc. | Sheikh S.,Jina Pharmaceuticals Inc. | Kale P.,Lambda Therapeutic | And 3 more authors.
Clinical Pharmacology and Therapeutics | Year: 2010

Endoxifen is an active metabolite of tamoxifen, a drug used in the treatment of breast cancer. In order to be clinically effective, tamoxifen must be converted to endoxifen by cytochrome P450 2D6 (CYP2D6). A study involving single escalating oral doses was conducted in humans to evaluate the safety, tolerability, and pharmacokinetics (PK) of endoxifen. This is the first study demonstrating that single oral doses of endoxifen are safe and well tolerated and have sufficient bioavailability to reach systemically effective levels in human subjects. Furthermore, it was found that endoxifen is rapidly absorbed and systemically available and that it displays dose proportionality in peak drug concentrations in plasma (Cmax) and area under the concentration-time curve extrapolated from 0 to ∞(AUC 0-∞) over the dose range 0.5-4.0mg. © 2010 American Society for clinical Pharmacology and Therapeutics.


Prajapati A.,Lambda Therapeutic | Ganguly B.,Pramukh Swami Medical College
Journal of Pharmacy and Bioallied Sciences | Year: 2013

Aim: Study was aimed to assess the accuracy of drug dose and its frequency in patients with renal dysfunction in a tertiary care hospital. Materials and Methods: This was a retrospective observational study. Patients > 18 years old, with the serum creatinine (SCr) level > 1.4 mg/dl were included. Drugs prescribed to these patients were recorded in case record form. Drugs for which the dose was adjusted according to the clinical response to therapy, not according to SCr level (i.e., angiotensin converting enzyme inhibitors, diuretics, B blockers, anti-diabetics, etc.) were not taken into consideration. Based on the creatinine clearance which was calculated by Cockroft-Gault formula, dose and frequency of prescribed drugs were assessed using «Drug prescribing in renal failure-dosing guidelines for adults, 4 th edition» and by another literature. Data was analyzed using Statistical Product and Service Solutions by IBM corporation version 17.0 software. Results: Total 278 indoor patients were screened, out of which 205 patients included. Total drugs prescribed to the patients were 1338 with the average of 6.53 drugs per patient. Out of these 180 (13.45%) drugs needed dose adjustment. Among them only 34 (18.89%) drugs were adjusted appropriately, and rest 146 (81.11%) were not adjusted. The most common group of drug that need dose adjustment was anti-microbials (144, 80%) with levofloxacin as individual drug. Conclusion: This study emphasizes the importance of patients with renal dysfunction and implementing appropriate dose adjustments. This study also suggests intervention such as on-line information to assist dose guidelines and participation of clinical pharmacologist could improve patient outcome.


Objective: To compare the bioavailability of single dose ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg administered alone or in combination as an oral suspension. Methods: This was a single-center, randomized, single-dose, open-label, 3-period, crossover study. After an overnight fast (≥10 h), 18 healthy male subjects received either ibuprofen 200 mg (reference-A), pseudoephedrine 30 mg (reference-B) or the combination (test-C) as a suspension, on 3 separate visits, with blood sampling up to 36-h post-dose. The primary pharmacokinetic parameters, maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) from time zero to last measurable concentration (AUC0-t) and extrapolated to infinity (AUC0-∞) were compared by an analysis of variance using log-transformed data. Bioequivalence was concluded if the 90% confidence intervals (CIs) of the adjusted geometric mean (gMean) ratios for Cmax and AUC were within the predetermined range of 80-125%, in accordance with regulatory requirements. Results: For the test formulation, the ibuprofen gMean Cmax was 17.0 μg/mL (vs. 18.1 μg/mL for reference-A), AUC0-t was 57.1 (vs. 60.0 μgh/mL), and AUC0-∞ was 59.9 μgh/mL (vs. 63.1 μgh/mL). The 90% CIs for the ratio (test/reference-A) were 81.0-108.1% for Cmax, 91.5-98.4% for AUC0-t and 91.6-97.9% for AUC0-∞. For pseudoephedrine, the gMean Cmax for the test formulation was 97.2 ng/mL (vs. 98.5 ng/mL for reference-B), AUC0-t was 878.4 (vs. 842.8 ngh/mL) and AUC0-∞ was 907.8 ngh/mL (vs. 868.3 ngh/mL). The 90% CIs for the ratio (test/reference-B) were 92.4-106.9% for Cmax, 97.7-111.0% for AUC0-t and 97.9-111.3% for AUC0-∞. All treatments were well tolerated. Conclusion: This oral suspension containing ibuprofen and pseudoephedrine combined in a new formulation met the regulatory criterion for bioequivalence compared with oral suspensions containing the individual components. © 2014 Kale.


PubMed | Nirma University and Lambda Therapeutic
Type: Journal Article | Journal: Pharmaceutical biology | Year: 2016

Quercetin, a flavonoid, has been tried in traditional medicine for treating many disorders and reported to have inhibitory action on PI3 kinase.This study investigates the effect of quercetin on testosterone propionate induced polycystic ovary syndrome (PCOS) model, which shows both metabolic and endocrine features of PCOS.Female pre-pubertal Sprague-Dawley rats were randomly divided into four groups: normal control, PCOS control, quercetin, and metformin treated. PCOS was induced by testosterone propionate (10mg/kg, s.c.) and treatments were carried out orally at the dose of 150mg/kg from the 6th week. At the 6th and 10th week, blood was collected to investigate metabolic indices, and reproductive biochemical parameters including morphology of ovary, uterus, and estrous cyclicity were assessed. The ovaries were processed to determine CYP17A1 gene expression.The treatment with quercetin did not modify body weight gain but uterine (296.75.11 versus 263.08.60mg) and ovary weights (49.51.93 versus 37.83.43mg) were found to be decreased significantly (p<0.05) as compared with the PCOS control group. The PCOS control group showed hyperinsulinemia, hyperandrogenemia, and dyslipidemia. Treatment with quercetin showed statistically significant (p<0.01) improvement in insulin (12.460.3 versus 10.00.28 U/ml), testosterone (0.650.02 versus 0.290.02 U/ml), luteinising hormone (20.60.28 versus 15.10.36 U/ml), and lipid profile. Histological examination of ovary and uterus confirmed the disease occurrence and remission state in the diseased and treated groups, respectively. Quercetin also demonstrated PI3 kinase inhibition in a docking study and decreased CYP17A1 gene expression.Thus, we can conclude that quercetin may have beneficial effect in PCOS by virtue of inhibition of PI3K which attributes to a decrease in the expression of CYP17A1 gene, having a key role in steroidogenesis.

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