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Bioanalytical Short Course
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Topic
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Speaker
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Time
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Introduction
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9:00 - 9:15 am
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Strategies in effective method development: current practices and challenges
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Ravi Rahavendran & Arshad Khuroo
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9:15 - 10:00 am
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Bioanalytical method validation and current regulatory guidelines
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Shrinivas Savale |
10:00 - 10:45 am
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Tea Break
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10:45 - 11:15 am
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Application of bioanalytical methods for discovery sample analysis (in vitro assays)
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Deepak Barot
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11:15 am - 12:00 pm
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Acceptance criteria, ISR, Reanalysis, Special Cases
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Shrinivas Savale
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12:00 - 12:45 pm
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Lunch Break
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1:00 - 2:00 pm
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Documantation requirements in bioanalysis and Quality Control/Quality Assurance functions in regulated bioanalysis
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Vinay Shedbalkar
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2:00 - 2:45 pm
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Ligand-Binding assays for bioanalysis of large molecules: Technology and Regulatory
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Renuka Pilutla
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2:45 - 3:30 pm
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Tea Break
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3:30 - 3:45 pm
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Bioanalytical data generation/handling and interpretation
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Vijay Raina
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3:45 - 4:30 pm
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Panel Discussion/Feedback/Q & A Session
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All Speakers
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4:30 - 5:00 pm
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Certificate Distribution
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5:00 - 5:15 pm
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(Head to Waters Minisymposium)
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Biotransformation Short Course
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Basic Biotransformation Concepts: Reaction Mechanisms, Enzymology, Metabolite Identification Tools, and Applications of Biotransformation Studies in Drug R&D
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Concept of biotransformation studies
a) Why study biotransformation of drug molecules? Role in drug discovery and development.
b) Chemistry of biotransformation reactions
c) Enzymes involved in biotransformation reactions (oxidative/reductive, hydrolytic, conjugative)
d) Importance of polymorphisms in metabolic enzymes
e) Time-dependent and irreversible inhibition of enzymes
f) Induction of enzymes
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Deepak Dalvie
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9:00 - 11:15 am
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Tea Break
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11:15 - 11:30 am
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Metabolism Studies: Tools and Techniques
a) In vitro matrices (subcellular fractions, hepatocytes)
b) In vivo in preclinical species and samples from FIH/hADME studies (circulating metabolites, excretory metabolites)
c) Metabolite identification techniques and tools (mass spec XIC including accurate mass, UV, NMR, fragmentation)
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Chandra Prakash
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11:30 am - 1:00 pm
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Lunch Break
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1:00 - 2:00 pm
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Application of biotransformation studies to R&D
a) Improve clearance properties during early screening
b) Bioactivation (protein binding, genetic toxicity) and chemistry interventions to remove liabilities
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Kaushik Mitra
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2:00 - 3:30 pm
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Tea Break
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3:30 - 3:45 pm
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Application of biotransformation studies to R&D (continued)
c) Metabolism-derived toxicity (BMS example of adrenal tox, Efavirenz)
d) Drug-Drug Interactions, value of phenotyping
e) Circulating metabolites and MIST regulatory guidances
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Kaushik Mitra
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3:45 - 5:00 PM
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Certificate Distribution
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5:00 - 5:15 pm
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| (Head to Waters Minisymposium) |
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