Changing need for bioanalysis during drug developmentNuggehally R Srinivas
Global Drug Development, ClinTec India International Pvt Ltd, Bangalore 560 025, India
Biomed Chromatogr 22:235-43. 2008
..e. discovery of a lead molecule) and progressing through various stages of drug development...
- Structurally modified 'dietary flavonoids': are these viable drug candidates for chemoprevention?
Nuggehally R Srinivas
Global Drug Development, ClinTec India International Pvt Ltd, 3rd Floor, A Wing, Divyasree Chambers, Langford Road, Bangalore 560 025, India
Curr Clin Pharmacol 4:67-70. 2009
..Overall, it appears prudent to develop a comprehensive prospective strategy for clinical development and regulatory approval...
- Dodging matrix effects in liquid chromatography tandem mass spectrometric assays--compilation of key learnings and perspectives
Nuggehally R Srinivas
Global Drug Development, ClinTec India International Pvt Ltd, Bangalore, India
Biomed Chromatogr 23:451-4. 2009
..This article captures some of the interesting work carried out by researchers to understand and handle matrix effects. Additionally, it provides perspectives to effectively deal with matrix effects...
- Sensitivity enhancement and matrix effect evaluation during summation of multiple transition pairs-case studies of clopidogrel and ramiprilat
J Manjunath Swamy
Lotus Labs Pvt Ltd, Lotus House, Vasanthnagar, Bangalore, India
Biomed Chromatogr 24:528-34. 2010
..Additionally, pharmacokinetic application of the MRM transition pair assays using a summation approach was established for the two compounds...
- Altered disposition of drugs in acute renal failure rat models: drug development strategies and perspectives
Nuggehally R Srinivas
Suramus Biopharm, Integrated Drug Development, Bangalore, India
Arzneimittelforschung 60:731-48. 2010
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- Prediction of human pharmacokinetic parameters using animal data and principles of allometry. A case using bicifadine, a non-narcotic analgesic, as an example
Nuggehally R Srinivas
Integrated Drug Development, Suramus Biopharm, Bangalore, India
Arzneimittelforschung 59:625-30. 2009
..Overall, based on the closeness of allometric exponents (within 15% of suggested values), simple allometry approach could be used to prospectively predict the human pharmacokinetic parameters of bicifadine with confidence...
- Influence of number of calibration standards within a defined range on pharmacokinetic disposition-case studies with omeprazole and clopidogrel carboxylic acid
Henry John Baptist D'Souza
Lotus Labs Pvt Ltd, Lotus House, Vasanthnagar, Bangalore, India
Biomed Chromatogr 24:544-9. 2010
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- A strategy for extending the applicability of a validated plasma calibration curve to quantitative measurements in multiple tissue homogenate samples: a case study from a rat tissue distribution study of JI-101, a triple kinase inhibitor
Sandip Dhondiram Gurav
Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India
Biomed Chromatogr 26:419-24. 2012
..Therefore, the use of a previously validated JI-101 assay in plasma circumvented the tedious process of method development/validation in various tissue matrices...
- Unsuspected poor metabolizer phenotypes of fluoxetine in bioavailability/bioequivalence studies from an indian population perspective. Retrospective pharmacokinetic data evaluation
Mani Kandasamy
Lotus Labs Pvt Ltd, Bangalore, India
Arzneimittelforschung 60:12-21. 2010
..Since the parent and metabolite levels are important from a therapeutic perspective, knowledge of phenotypic distribution of the population may be an important consideration...
- Intravenous prediction of human pharmacokinetic parameters for ketorolac, a non-steroidal anti-inflammatory agent, using allometry approach
Ravindranath Reddy Gilibili
Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Yeshwanthpur, Bangalore, India
Eur J Drug Metab Pharmacokinet 36:87-93. 2011
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- Antacid use and reduced bioavailability of oral drugs. Case studies, overview and perspectives
Nuggehally R Srinivas
Integrated Drug Development, Suramus Biopharm, Bangalore, India
Arzneimittelforschung 59:327-34. 2009
..While possible mechanisms explaining the purported antacid-drug interaction are covered, additional perspectives with regard to assessment protocols for antacid-drug interaction are discussed...
- Considerations for metabolite pharmacokinetic data in bioavailability/bioequivalence assessments. Overview of the recent trends
Nuggehally R Srinivas
Integrated Drug Development, Suramus Biopharm, Bangalore, India
Arzneimittelforschung 59:155-65. 2009
..Also, some useful considerations from both bioanalytical and pharmacokinetic perspectives are proposed...
- Sensitivity enhancement in tandem liquid chromatographic mass spectrometric assays by summation of two transition ion pairs--perspectives
Nuggehally R Srinivas
Integrated Drug Development, Suramus Biopharm, J P Nagar I Phase, Bangalore, India
J Sep Sci 32:483-6. 2009
..Some researchers have also expressed thoughts of using matrix effects in a beneficial manner so that there may be ion enhancement for improving the sensitivity of the assay...
- Digoxin - a therapeutic agent and mechanistic probe: review of liquid chromatographic mass spectrometric methods and recent nuances in the clinical pharmacology attributes of digoxin
Nuggehally R Srinivas
Suramas Biopharm, J P Nagar I Phase, Bangalore, 560 078, India
Bioanalysis 1:97-113. 2009
..Overall, liquid chromatographic-mass spectrometric assays represent an important tool for many future preclinical, clinical and mechanistic probe studies that would probe digoxin with or without other coadministered substrates...
- Genetic CYP2C19 polymorphism dependent non-responders to clopidogrel therapy--does structural design, dosing and induction strategies have a role to play?
Nuggehally R Srinivas
Suramus Biopharm, Integrated Drug Development, J P Nagar I Phase, Bangalore 560 025, India
Eur J Drug Metab Pharmacokinet 34:147-50. 2009
..Such thought process and novel explorations are important for delivering medicines in genetically and ethnically diverse populations...
- Role of stereoselective assays in bioequivalence studies of racemic drugs: have we reached a consensus?
Nuggehally R Srinivas
Dr. Reddy's Research Laboratories-Discovery Research, Bollaram Road, Miyapur, Hyderabad, India
J Clin Pharmacol 44:115-9. 2004
..However, examination of the literature suggests that nonstereoselective data are commonly used for the bioequivalence assessment of drug racemates...
- Evaluation of experimental strategies for the development of chiral chromatographic methods based on diastereomer formation
Nuggehally R Srinivas
Drug Development Group, Discovery Research, Dr Reddy s Laboratories, Bollaram Road, Miyapur, Hyderabad 500 050, India
Biomed Chromatogr 18:207-33. 2004
..Also, it provides an exhaustive list of applications of numerous chiral derivatization reagents that have been used in the generation of stereoselective pharmacokinetic data...
- Clinical pharmacokinetic data of racemic drugs obtained by the indirect method following precolumn diastereomer formation: is the influence of racemization during chiral derivatization significant?
Nuggehally R Srinivas
Drug Development, Discovery Research, Dr Reddy s Laboratories Bollaram Road, Miyapur, Hyderabad 500 049, India
Biomed Chromatogr 18:343-9. 2004
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- Analysis of five HMG-CoA reductase inhibitors-- atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin: pharmacological, pharmacokinetic and analytical overview and development of a new method for use in pharmaceutical formulations analysis a
Md Khalid Pasha
Drug Metabolism and Pharmacokinetics, Discovery Research, Dr. Reddy's Laboratories Ltd, Miyapur, Hyderabad, India
Biomed Chromatogr 20:282-93. 2006
..2, 21.6, 28.5, 33.5 and 35.5 min, respectively. The proposed method is simple, selective and could be applicable for routine analysis of HMG-CoA reductase inhibitors in pharmaceutical preparations as well as in vitro metabolism studies...
- Applicability of bioanalysis of multiple analytes in drug discovery and development: review of select case studies including assay development considerations
Nuggehally R Srinivas
Drug Development, Discovery Research, Dr Reddy s Laboratories Limited, Bollaram Road, Miyapur, Hyderabad, India
Biomed Chromatogr 20:383-414. 2006
..Additionally, some key elements such as internal standard selection, likely issues of mass detection, matrix effect, chiral aspects etc. are provided for consideration during method development...
- Drug disposition of chiral and achiral drug substrates metabolized by cytochrome P450 2D6 isozyme: case studies, analytical perspectives and developmental implications
Nuggehally R Srinivas
Drug Development, Discovery Research, Dr Reddy s Laboratories, Miyapur, Hyderabad, India
Biomed Chromatogr 20:466-91. 2006
..Additionally, wherever applicable, special emphasis is provided on chiral drug substrates in the various subsections of the review...
- Bioanalytical considerations for compounds containing free sulfhydryl groups
Nuggehally R Srinivas
Department of Bioanalysis, Drug Metabolism and Pharmacokinetics, Discovery Research, Dr Reddy s Research Laboratories, Bollaram Road, Miyapur, Hyderabad 500 050, India
Biomed Chromatogr 17:285-91. 2003
..This review provides some critical insights to many such considerations that may be vital for development and validation of methods for thiol-containing drugs...
