International Conference and Exhibition on Bioequivalence & Bioavailability 2010 - BIOBIO-2010 Scientific Programme
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Event Sponsors:

 
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Agilent Technologies India Pvt. Ltd., India
 
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Synchron Research Services Pvt. Ltd., India
 
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Novartis, USA
 
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GSB Life Sciences, USA
 
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Cetero Research, USA
 
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Pharmaceutics International, Inc, USA
 
 
 
 

Scientific Programme
Track Information Day 1: 01 March 2010
Keynote Forum

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

9:00 - 9:25

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.

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.

9:50 - 10:15

 

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.

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.

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.

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.

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.

Sponsor/
Partial supporter/
Co-organizer

Track 1: Practical Solutions to Pharmaceutical Bioequivalence/Bioavailability Implementation

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Aurobindo Pharma Ltd., India

Rhodes
Rhodes University,
South Africa


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University of Notre Dame, USA

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Faculty of Medicine Siriraj Mahidol University, Thiland


 

 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.

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.

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.

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.

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.

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.

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.

17:10-17:35

Title: Challenges of Bioequivalence Studies in the Middle East
Dr. Maha Tutunji

17:35-18:00 Panel Discussion

Reddy
Dr. Reddy's Laboratories, India

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Abbott Laboratories, USA

PNUTUS2
Universiti Sains Malaysia, Malaysia

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Al-Ameen College of Pharmacy, India

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University of Canberra, Australia


 

 

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.

13:30-13:55

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Dr. V. Venkateswarlu, Dr. Reddy's Laboratories, India.

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.

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.

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.

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.

17:35-18:00 Panel Discussion

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Synchron Research Services Pvt. Ltd., India

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University of Hyderabad,
India

Karnataka
Karnataka State Open University, India

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Cipla Ltd., India

NIET
Noida Institute of Engg & Tech, India

Texas
Texas Tech School of Pharmacy , USA

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.

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.

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.

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.

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.

17:10-17:35

Dr. Fakhrul Ahsan, Department of Pharmaceutical Sciences,
Texas Tech School of Pharmacy, Amarillo, Texas, USA.

17:35-18:00 Panel Discussion
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International Pharmaceutical Research Center, Jordan

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University of Petra,
Jordan


Jadavpur
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
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Professor of Pharmaceutics,
Chairman, International Pharmaceutical Research Center (IPRC),
1 Queen Rania Street - Sport City Circle,
P.O. Box 963166, Amman 11196, Jordan.

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.

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.

16:45-17:10

Dr. Fotso Wabo Ghislain

17:35-18:00 Panel Discussion
 
Welcome Banquet  : March 01, 2010 Call for sponsor!
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


Participants List
(Business)
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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