HIV Clinical Pharmacology and Implementation Research in YRG CARE, India S. Saravanan, PhD 4 th...
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Transcript of HIV Clinical Pharmacology and Implementation Research in YRG CARE, India S. Saravanan, PhD 4 th...
![Page 1: HIV Clinical Pharmacology and Implementation Research in YRG CARE, India S. Saravanan, PhD 4 th Annual Workshop on.](https://reader035.fdocuments.us/reader035/viewer/2022062308/56649dd25503460f94ac96ab/html5/thumbnails/1.jpg)
HIV Clinical Pharmacology and ImplementationResearch in YRG CARE, India
S. Saravanan, PhD
4th Annual Workshop on
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• YRGCARE Medical Center is a 20- bed clinical facility with an
intensive care unit, an outpatient unit, counseling and nutritional
services, a subsidized pharmacy with adherence program.
• YRGCARE has a well developed Hospital Management System
(HMS) database which integrates the clinic, laboratory and
pharmacy. The Natural History Database (NHD), a subset of the HMS,
provides valuable insight about the progression of HIV disease in India.
• YR Gaitonde Centre for AIDS Research and Education (YRGCARE) in Chennai, India is a non-profit medical and research institution. Established in 1993, the activities are organized around
four core areas - Education, Care & Support, Research and Training.
Background
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• YRG CARE Infectious Diseases Laboratory is quality assured by the College of American Pathologists (USA) and UK-
NEQAS (UK), quality controlled by the Johns Hopkins University, USA and Virology Quality Assurance Program, Rush, USA
• YRG CARE (Site ID: 11701 & Lab ID: 316) is one of the international multi site of NIH multi-centric clinical trials sponsored by DAIDS through HPTN and ACTG programs from the year 2000.
• YRG CARE performs all the protocol assays, which include HIV-RNA & DNA PCR, CD4, blood chemistries, CBC, infectious diseases serology, clinical pathology and diagnosis of opportunistic infections including TB.
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• Affiliated to the University of Madras, Chennai for conducting Ph.D. degree program in Medical Microbiology.
• Biochemistry, Clinical Pathology, HIV Genotyping Lab, Hematology & Immunology, Microbiology, Serology, Virology & Molecular biology
• Accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL, New Delhi) and the NABL accreditation is assessed in accordance with ISO 15189:2007 standards for medical laboratories.
• YRG CARE Laboratory is the very first HIV specialty laboratory got accredited by the NABL in India.
![Page 5: HIV Clinical Pharmacology and Implementation Research in YRG CARE, India S. Saravanan, PhD 4 th Annual Workshop on.](https://reader035.fdocuments.us/reader035/viewer/2022062308/56649dd25503460f94ac96ab/html5/thumbnails/5.jpg)
Objectives
• Development and validation of analytical procedures for the quantification of antiretroviral agents.
• Participation in the DAIDS HIV Clinical Pharmacology Quality Assurance (CPQA) program.
• Implementation of DAIDS mandated requirements eventually to become Pharmacology Specialty Laboratory to support the scientific agenda of the DAIDS.
HIV Clinical Pharmacology and Implementation
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Translational Pharmacology Research CoreNYS Center of Excellence in Bioinformatics and Life Sciences
701 Ellicott StreetBuffalo , NY 14203
Pharmacology lab visit
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• Orientation about Alliance e2695
2998/PDA
• Preventive maintenance
Priming the Solvent Management System
Dry Priming & Wet Priming
Priming the Needle-Wash Pump
Priming the Plunger Seal-Wash Pump
Purging the Injector
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• Priming• Fixing column• Conditioning the Column
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• Sample preparation
• Mobile phase preparation
• Loading Carousels
• Empower software & utility
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1. Configure system
2. Creating instrument method
3. Creating method set
4. Processing method
5. Reporting format
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NVP estimation using Xanthine as IS
• Reverse Phase HPLC• Liquid Extraction – Ethyl Acetate• Mobile Phase: KH2PO4:ACN(90:10)
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Calibration Curve
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Peak Summary
Peak Summary Report
Retention Time: 6.75 mins for Xanthine; 8.02 mins for NVP
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Estimation of Stavudine and Lamivudine using Didanosine as the Internal Standard
Solid Phase Extraction Method Oasis HLB cartridges
3TC : 8.30 mins
DDI(IS): 10.23 mins
D4T : 11.98 mins
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Current Status• Alliance e2695 /2998 PDA – Installed
• Completed Instrumentation & Application training
• Process of NIH Fogarty Application: UB AIDS Clinical Trials Group PSL & YRG CARE Planning Grant for Fogarty HIV Research Training Program for Low- and Middle- Income Country Institutions (D71)
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• Upon the completion of technology transfer from UB, the assays will
be standardized and will complete the CPQA panels. Eventually the
PSL would support the scientific agenda of the ACTG/HPTN.
• The established PSL would carry out protocol-required pharmacologic
assays - analysis of PK/PD data from both primary protocols and sub-
studies.
• Develop concept proposal and integrate pharmacologic research
questions with the ACTG/HPTN scientific agenda.
Anticipated contribution of establishing Clinical Pharmacology at YRG CARE:
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Thanks