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Scientific Programme
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Track Information Day 1: 01 March 2010 |
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Opening Ceremony |
8:00 - 8:10 |
Group Photo/Prayer |
8:20 - 8:30 |
Chair's Opening Remark |
8:30 - 9:00 |
VIP's Address |
Keynote Forum |
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Title: Challenges in BE Requirements for Certain Class / Types of Drug Products
Dr. Vinod P. Shah, Pharmaceutical Consultant,
Documentary Standards Division,
US Pharmacopeia, 12601 Twinbrook
Parkway,
Rockville, MD, USA.
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9:25 -9:50
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Title: Scientific and Regulatory Challenges of Bioavailability/Bioequivalence in the 21st Century
Dr. Mansoor A. Khan,
Director, Division of Product Quality Research,
FDA/CDER/OPS/OTR,
White Oak, LS Building 64,
Room 1070,
10903 New Hampshire Ave,
Silver Spring, MD, USA.
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9:50 - 10:15
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Title: Anti-angiogenesis Therapy: Past, Present and Future
Prof. Debabrata Mukhopadhyay,
Department of Biochemistry and Molecular Biology,
Mayo Clinic School of Medicine,
Guggenheim 1401A,
200 First Street Southwest, Rochester, MN 55905, USA.
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| 10:15 - 10:25 |
Coffee Break |
10: 25 - 10:50
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Title: Critical Pathway Initiative of Generic Drug Development
Dr. Shivprakash Rathnam, Managing Director,
Synchron Research Services Pvt. Ltd., Ahmadabad, India.
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10:50 - 11:15
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Title: Optimizing Systemic Exposure in Preclinical Species and Humans: Practical Strategies and Learnings for Discovery and Development
Dr. Tycho Heimbach,
Novartis Institutes for BioMedical Research,
DMPK - Translational Sciences (TS),
USEH, 436/3253,
One Health Plaza,
East Hanover, NJ 07936-1080,
USA.
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11:15 - 11:40
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Title: Challenges Encounterd in the Conduction of Bioequivalence Studies of Some Drug Products
Dr. Naji M. Najib,
Professor of Pharmaceutics,
Chairman,
International Pharmaceutical Research Center (IPRC),
1 Queen Rania Street - Sport City Circle,
P.O. Box 963166, Amman 11196, Jordan.
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11:40 - 12:05
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Title: On Modeling Methods and Predictability of In-Vitro-In-Vivo Correlation (IVIVC)
of Oral Controlled Release Products
Dr. Bhaswat S. Chakraborty, Sr. Vice President, R&D, Cadila Pharmaceuticals, India.
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Sponsor/
Partial supporter/
Co-organizer |
| Track 1: Practical Solutions to Pharmaceutical Bioequivalence/Bioavailability Implementation |
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Food and Drug Administration, USA
Aurobindo Pharma Ltd., India
Rhodes University,
South Africa
University of Notre Dame, USA
Faculty of Medicine Siriraj Mahidol University, Thiland
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| Time |
Track |
March 1, 2010
(Monday)
13:00-18:00 |
Track 1-1: Bioequivalence Strategies in Development-an Industry Perspective |
| Session Chair: |
Dr. Sam H. Haidar, Lead Pharmacologist,
Office of Generic Drugs,
Food and Drug Administration,
Rockville, Maryland, USA.
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Session
Co-Chair:
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Dr. A.T. Bapuji,
Vice president, Clinical Pharmacology Department,
APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad, India. |
| 13:00-13:05 |
Session Introduction |
13:05-13:30
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Title: Recent Advances in the Evaluation of Bioequivalence
Dr. Sam H. Haidar, Lead Pharmacologist,
Office of Generic Drugs,
Food and Drug Administration,
Rockville, Maryland, USA.
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13:30-13:55
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Title: Bioequivalence Testing - Industry Prespective
Dr. A.T. Bapuji,
Vice president, Clinical Pharmacology Department,
APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad, India.
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13:55-14:20
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Title: Current Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms
Dr. Isadore Kanfer, Emeritus Professor,
Faculty of Pharmacy,
Rhodes University,
Grahamstown, South Africa.
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14:20-14:45
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Title: Quick Assay of Pathogenic Bacteria in Kidney Infection using Gold Nano-Biosensors
Dr. Subhash C. Basu,
University of Notre Dame,
Notre Dame, Indiana 46556,
Department of Chemistry
and Biochemistry, USA.
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| 14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45
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Dr. Ethan M. Stier, R.Ph., PhD, Division of Bioequivalence II,
Office of Generic Drugs,
Food and Drug Administration Rockville, MD 20855, USA.
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16:45-17:10
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Title: The Situation of Bioequivalence Studies in Thailand: Past, Present, and Future
Dr. Supornchai Kongpatanakul, MD,
Head,
Department of Pharmacology and Siriraj Bioequivalence Center,
Faculty of Medicine Siriraj
Mahidol University,
Bangkok,
Thailand.
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| 17:10-17:35 |
Title: Challenges of Bioequivalence Studies in the Middle East
Dr. Maha Tutunji
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| 17:35-18:00 |
Panel Discussion |
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Dr. Reddy's Laboratories, India
Abbott Laboratories, USA
Universiti Sains Malaysia, Malaysia
Al-Ameen College of Pharmacy, India
University of Canberra, Australia
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March 1, 2010
(Monday)
13:00-18:00 |
Track 1-2: Comparative Bioavailability Studies for New Drugs (NDA) |
| Session Chair: |
Dr. V. Venkateswarlu, Dr. Reddy's Laboratories, India |
Session
Co-Chair:
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Dr. Rajendra S Pradhan,
Director,
Clinical Pharmacokinetics and Pharmacodynamics,
Clinical Pharmacology and Pharmacometrics,
Abbott labs,
Abbott Park, IL, USA. |
| 13:00-13:05 |
Session Introduction |
13:05-13:30
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Title: Challenges in Conducting BA/BE Assessments During Clinical Development of Oncology Drugs
Dr. Rajendra S Pradhan,
Director,
Clinical Pharmacokinetics and Pharmacodynamics,
Clinical Pharmacology and Pharmacometrics,
Abbott labs,
Abbott Park, IL, USA.
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13:30-13:55
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Dr. V. Venkateswarlu, Dr. Reddy's Laboratories, India.
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13:55-14:20
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Title: Evaluating Effect of Self-Microemulsifying Drug Delivery Formulation and Concomitant Administration of Piperine on Bioavailability of Sulpiride, a P-gp Substrate and BCS Class IV Drug
Dr. Peh Kok Khiang,
School of Pharmaceutical Sciences,
Universiti Sains Malaysia,
11800 Penang, Malaysia.
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14:20-14:45
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Title: In-Vitro and In-Vivo Evaluation of Microprocessor Controlled Iontophoretic Transdermal Drug Delivery of Anti-Cancer Drugs
Dr. Chandrashekar NS, Al-Ameen College of Pharmacy,
Near Lalbagh Main Gate, Hosur Road,
Bangalore-560027, India.
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| 14:45-16:20 |
Coffee Break & Poster Session |
| 16:20-16:45 |
Title: Bioequivalence in Trans dermals
Dr. Charu Gautam, Director- Clinical Operations,
BA Research India Ltd,
Ahmedabad, India.
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| 16:45-17:10 |
Dr. Rachel W. Li,
Trauma and Orthopaedic Research Laboratory,
The Australian National University Medical School,
University of Canberra,
Division of Immunology and Genetics,
JCSMR, Australia.
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| 17:35-18:00 |
Panel Discussion |
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Synchron Research Services Pvt. Ltd., India
University of Hyderabad,
India
Karnataka State Open University, India
Cipla Ltd., India
Noida Institute of Engg & Tech, India
Texas Tech School of Pharmacy , USA
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March 1, 2010
(Monday)
13:00-18:00 |
Track 1-3: Comparative Bioavailability Generic Drug Products (ANDA): Bioequivalence Studies |
| Session Chair: |
Dr. Shivprakash Rathnam, Managing Director,
Synchron Research Services Pvt. Ltd., Ahmadabad, India. |
Session Co-Chair:
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Dr. Ashwini Nangia,
School of Chemistry,
University of Hyderabad, Hyderabad 500 046, India. |
| 13:00-13:05 |
Session Introduction |
13:30-13:55
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Title: Pharmaceutical Cocrystals to Modify Physico-Chemical and Dissolution Profile of APIs
Dr. Ashwini Nangia,
School of Chemistry,
University of Hyderabad, Hyderabad 500 046, India.
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| 13:55-14:20 |
Title: Synthesis of Novel Heterocyclic Compounds for Induction of Apoptosis in Human Leukemia Cells
Prof. K.S. Rangappa, Vice-Chancellor,
Karnataka State Open University(KSOU),
Manasagangotri,
Mysore-570 006, India.
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| 14:20-14:45 |
Title: Challenges in the Design of Comparative Bioavailability Studies – An Industry Perspective
Dr. Siddarth S. Chachad,
Medical & Safety Expert (Regulatory Affairs),
Cipla Ltd., India.
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| 14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45
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Title: Bioequivalence Strategies for Oncology Products
Dr. Shivprakash Rathnam, Managing Director,
Synchron Research Services Pvt. Ltd., Ahmadabad, India.
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16:45-17:10
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Title: Bioavailability and Bioequivalence Studies of Citric Acid and Malonic Acid Based Aspirin Effervescent Tablets
Dr. Sanjita Das,
Head,
Department of Pharmaceutical Technology,
Noida Institute of Engg & Tech, Greater Noida, India.
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| 17:10-17:35 |
Dr. Fakhrul Ahsan, Department of Pharmaceutical Sciences,
Texas Tech School of Pharmacy,
Amarillo, Texas, USA.
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| 17:35-18:00 |
Panel Discussion |
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International Pharmaceutical Research Center,
Jordan
University of Petra,
Jordan
Jadavpur University,
India |
March 1, 2010
(Monday)
13:00-18:00 |
Track 1-4: Implementing BA/BE Guidelines and CRO Qualification Criteria |
| Session Chair: |
Dr. Naji M. Najib,
Professor of Pharmaceutics,
Chairman,
International Pharmaceutical Research Center (IPRC),
1 Queen Rania Street - Sport City Circle,
P.O. Box 963166, Amman 11196, Jordan. |
| Session Co-Chair: |
Dr. Nasir M. Idkaidek,
College of Pharmacy & Medical Sceinces,
University of Petra,
Amman, Jordan. |
| 13:00-13:05 |
Session Introduction |
13:05-13:30
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Title: Effect of Replicate Design on Drug Variability and Bioequivalence in Humans
Dr. Naji M. Najib, Professor of Pharmaceutics,
Chairman,
International Pharmaceutical Research Center (IPRC),
1 Queen Rania Street - Sport City Circle,
P.O. Box 963166, Amman 11196, Jordan.
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13:30-13:55
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Title: Effect of Truncated AUC Method on Drug Bioequivalence in Humans: an EMEA Draft Guideline Evaluation
Dr. Nasir M. Idkaidek,
College of Pharmacy & Medical Sceinces,
University of Petra,
Amman, Jordan.
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| 14:45-16:20 |
Coffee Break & Poster Session |
| 16:20-16:45 |
Title: Bioequivalence Study of Two FDC Formulations Containing Metformin, Glibenclamide and Pioglitazone in Healthy Indian Volunteers
Dr. Tapan Pal, Bioequivalence Study Centre,
Jadavpur University,
Kolkata, India.
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| 16:45-17:10 |
Dr. Fotso Wabo Ghislain
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| 17:35-18:00 |
Panel Discussion |
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| Welcome Banquet : March 01, 2010 Call for sponsor! |
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University of Notre Dame, USA
Faculty of Medicine Siriraj Mahidol University, Thailand
Nova Southeastern University, USA
The Australian National University Medical School, University of Canberra, Australia
University of Hyderabad, India
Panjab University, Chandigarh, India
Institute of Biotechnology and Antibiotics, Warsaw, Poland
Texas Tech School of Pharmacy, USA
University of Petra, Jordan
Jadavpur University, India
University of British Columbia, Canada
Canadian Society for Pharmaceutical Sciences, Canada
National University of Singapore, Singapore
King Saud University, Saudi Arabia
Widener University, USA
Stanford University School of Medicine, USA
University at Buffalo, State University of New York, USA
School of Biological Sciences, University of Edinburgh, UK
Chungnam National University, Korea
Harvard Medical School, USA
Polish Academy of Sciences, Poland
University of Trieste, Italy
College of Pharmaceutical Sciences, MAHE, India
Medical School, University of Athens, Greece
Universiade Federal da Bahia, Instituto de Ciências da Saude, Brazil
University of Region of Cariri - URCA, Brazil
Tabriz University of Medical Sciences, Iran
Johns Hopkins University, USA
Creighton University Medical Center and University of Nebraska Medical Center, USA
University of Pisa, Italy
The University of Liverpool, UK
The Islamia University of Bahawalpur, Pakistan
University of California, Sanfransisco, USA
Al-Qassim University, College of Pharmacy Buraidah, Saudi Arabia
University of Madras, India
SRM University NCR Campus, India
University of Peradeniya, Sri Lanka
Yokohama City University, Graduate School of Medicine, Japan
Radboud University Nijmegen Medical Center, The Netherlands
Qilu Hospital of Shandong University, China
Meerut Institute of Engineering and Technology, India
Florida A & M University, College of Pharmacy, USA
Jawaharlal Nehru Technological University, India
Ludwig-Maximilians University, Germany
V.L. College of Pharmacy, India
University of Alberta, Canada
Panjab University, India
Monash Institute of Pharmaceutical Sciences, Monash University, Australia
University of British Columbia, Brain Research Centre, Canada
Univ Inst Pharm Sci (UGC Center of Adv Studies), Panjab University, India
Institut Supérieur de Biotechnologies de Sfax, Tunisie
All India Institute of Medical Sciences, India
Rhodes University, South Africa
Université Paris, France
Faculty of Pharmacy, University of Ljubljana Askerceva 7, Slovenia
Chungnam National University, Korea
Dr H S Gour University, India
National School of Public Health, Ministry of Health, Brazil
University of Toronto, Canada
Oncology Institute of Vojvodina , Serbia
Indian Institute of Chemical Technology, India
Indian Institute of Toxicology Research, India
Einstein Heart and Vascular Institute, Albert Einstein Medical Center, USA
University of Texas at Austin, USA
National Institute for Research in Reproductive Health (ICMR), India
National Cancer Institute, USA
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US Pharmacopeia, USA
Food and Drug Administration, USA
University Hospital Zurich, Switzerland
B. V. Patel Perd Centre, India
Guy's Hospital, UK
Hôpital Saint-Antoine, Paris
A. Manzoni Hospital, Italy
Kazusa DNA Research Institute, Japan
Pharmaceutics Int., Inc., USA
Agilent Technologies, USA
Central Drug Research Institute, India
EMF Consulting, France
Hopital Cochin, Paris
Boys Town National Research Hospital, Omaha, USA
Aurobindo Pharma Ltd., India
Abbott labs, USA
Synthon BV, The Netherlands
Children's Hospital Medical Center, USA
Piramal Life Sciences, India
AstraZeneca R&D Mölndal, Sweden
Sun Pharma Advanced Research Company Limited, India
Ranbaxy Research Laboratories, India
University Children's Hospital Basel UKBB, Switzerland
Huashan hospital of Fudan University, China
Novartis Institutes for BioMedical Research, USA
Defence Research and Development Canada Suffield, Canada
Saudi Food and Drug Authority, Saudi Arabia
Cetero Research, USA
Panacea Biotec Ltd., India
Lupin Ltd., India
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