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Short Course Biotransformation
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Topic
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Speaker
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Time
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Case studies; Transporters; LC-MS/MS; Recent regulatory updates; New technologies in transporter assay; Clinical DDI;Reactive metabolites and technology discussion.Issues encountered in Discovery/Biotransformation and how to resolve them.
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Instructors
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Topic
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Time slot
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Jonathan Josephs, BMS
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Case Study of Quan/Qual Applied to Drug Discovery
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9.00 - 9.35
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Murali Subramanian, BBRC
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Reaction Phenotyping by Metabolite Formation with Radiolabeled Compounds: Further Application of Methodology to In vivo Studies
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9.40 - 10.15
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Tea break
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10.15 -10.30
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Michael Sinz, BMS
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CYP450 Enzyme Inhibition Reversible, Irreversible, Mixed, Other ?
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10.30-11.05
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| Bill Smith, BMS |
Prediction of Crizotinib-Midazolam Interaction using the Symcyp Population based simulator- Comparison of CYP3A Time Dependent Inhibition between Human Liver Microsomes versus Hepatocytes
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11.10-11.45
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Girish Gudi, Glenmark
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Clinical DDI Study Design Considerations
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11.50-12.25
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Sandhya Mandlekar
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Panel Discussion, Participant Q and A
Lunch time
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12.25-12.45
12.45-13.45
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Kunal Taskar, BBRC
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Membrane Transporters Introduction
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13.45-14.20
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Jasminder Sahi, GSK
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Current Recommendations for Transporter – Mediated Drug Interaction Assessments from the FDA & EMA
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14.25-15.00
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Tea break
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15.00-15.15
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Berend Oosterhuis, SOLVO
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In vitro Drug Transporter Studies Practical Aspects
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15.15-15.50
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Panel Discussion, Participant Q and A
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16.00-17.00
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Short Course Bioanalysis
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Case studies; ADME Assays & Bioanalytical challenges; Ligand binding assays; Readiness for regulatory audits; Case studies on bioanalytical challenges; Current updates on regulatory guidelines, DBS & its application in Discovery; Utility of HRMS in quantitation; Utility of Biostatistics in Bioanalysis and Regulatory guidelines etc.
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Instructors
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| Bioanalysis Short Course 2013 |
| Morning Session |
| Short course Agenda |
Instructor |
Time slot |
| Introduction |
Deepak Barot, Microtherpeutics |
9:20-9:30 |
| Fundamentals of Bioanalysis |
Tim Olah, BMS |
9:30- 10:30 |
| Tea break |
10:30-10:45 |
| Dried Blood Spot Technology: Methodological intricacies, opportunities and challenges in Discovery Bioanalysis |
Prashant Kole, BBRC |
10:45- 11:30 |
| Utility of High Resolution Mass Spectrometry in Quantitation |
Jonathan Josephs,BMS |
11:30- 12:30 |
| Lunch break |
12:30- 13:30 |
| Afternoon Session |
| Readiness for regulatory audits |
Vinay Shedbalkar, Pharmaedge |
13:30- 14:15 |
| Handling Multiple Guidance for Regulated work |
Manish Yadav, Alkem |
14:15- 15:00 |
| Tea break |
15:00- 15:30 |
| Utility of Biostatistics in Bioanalysis and Regulatory guidelines etc. |
Vinay Shedbalkar, Pharmaedge |
15:30- 16:30 |
| Panel Discussion |
16:30-17:00 |
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In vitro Drug Transporter Studies Practical Aspects
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