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Scientific Programme
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Track Information |
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Track 2: Pharmacokinetic/Pharmacodynamic Models, Biowaivers and Biosimilars |
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![](images/petralogo.jpg)
University of Petra,
Jordan
![](images/University_Hospital_Zurich.jpg)
University Hospital Zurich, Switzerland
![](images/B_V.jpg)
B. V. Patel Perd Centre, India
![](images/Jamia_Hamdard.jpg)
Jamia Hamdard, India
![](images/nuslogo.gif)
National University of Singapore, Singapore
![](images/Ege_University.jpg)
Ege University, Turkey |
Time |
Track |
March 2, 2010
(Tuesday)
8:30-12:00 |
Track 2-1: Human/Animal Models in Oral Drug Absorption |
Session Chair:
![nasir](thumbnails BIOBIO/march 2nd/Nasir M. Idkaidek_edt_thumb.jpeg)
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Dr. Nasir M. Idkaidek,
College of Pharmacy & Medical Sceinces,
University of Petra,
Amman, Jordan. |
Session Co-Chair
:![qw](images/thumbnails BIOBIO/march 2nd/Antonie Malek_edt_thumb.jpeg)
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Dr. Antoine Malek, University Hospital Zurich,
Department of Obstetrics,
Research Division,
Frauenklinikstr. 10,
8091 Zurich, Switzerland. |
8:30-8:35 |
Session Introduction |
8:35-9:00 ![ww](images/thumbnails BIOBIO/march 1st/harish-padh.jpg) |
Title: Inter-individual Variability and Drug Development: BA/BE as Research Tool
Dr. Harish Padh,
Director,
B. V. Patel Perd Centre,
Thaltej-gandhinagar highway,
Thaltej,
Ahmedabad, India.
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9:00-9:25 ![aa](images/thumbnails BIOBIO/march 1st/Sushama_Talegaonkar.jpg) |
Title: Bioavailability Enhancement of Ropinirole by Using Nanoemulsion Based System
Dr. Sushama Talegaonkar,
Department of Pharmaceutics,
Faculty of Pharmacy, Jamia Hamdard, New Delhi-110062, India.
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9:25-9:50 ![s](images/thumbnails BIOBIO/march 2nd/Antonie Malek_edt_thumb.jpeg) |
Title: The Importance of the Human Placenta Ex Vivo Perfusion Model in the Drug Development for Human Pregnancy
Dr. Antoine Malek, University Hospital Zurich,
Department of Obstetrics,
Research Division,
Frauenklinikstr. 10,
8091 Zurich, Switzerland.
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9:50-10:15
![nasir](thumbnails BIOBIO/march 2nd/Nasir M. Idkaidek_edt_thumb.jpeg)
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Title: Enhancement of Oral Bioavailability of Insulin in Humans
Dr. Nasir M. Idkaidek,
College of Pharmacy & Medical Sceinces,
University of Petra,
Amman, Jordan.
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10:15-10:25 |
Coffee Break |
10:25-10:50 ![gvSAfv](images/thumbnails BIOBIO/march 1st/gopal.jpg) |
Title: Drug Discovery from Natural Toxins and on Animal models
Dr. P.Gopalakrishnakone,
President, International Society on Toxinology,
Department of Anatomy & Venom and Toxin Research Programme,
Yong Loo Lin School of Medicine,
National University of Singapore,
Lower Kent Ridge Road, Singapore.
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10:50-11:15 |
Title: Human/Animal Models in Oral Drug Absorption
Dr. Ercument Karasulu,
Assoc.Professor,
Ege University,
Center for Drug R&D and Pharmacokinetic
Applications,
35100 Bornova, IZMIR, Turkey.
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11:40-12:00 |
Panel Discussion |
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|
![](images/Renal_Unit.jpg)
Renal Unit, UK
![](images/ksulogo.jpg)
King Saud University,
Saudi Arabia
![](images/University_Hospital_Zurich.jpg)
University Hospital Zurich, Switzerland
![](images/Saint-Antoine_logo.JPG)
Hôpital Saint-Antoine, Paris
![](images/EMEA.jpg)
European Medicines Agency, UK
![](images/Alessandro.jpg)
Alessandro Manzoni Hospital, Italy
![](images/Widener_logo.JPG)
Widener University, USA
|
March 2, 2010
(Tuesday)
13:00-18:00 |
Track 2-2: Biosimilars and Biowaivers |
Session Chair: ![sf](images/thumbnails BIOBIO/march 1st/david goldsmith.jpg) |
Dr. David Goldsmith, Renal Unit, New Guy House,
Guy's Hospital, London, UK. |
Session Co-Chair:
![khalid](thumbnails BIOBIO/march 2nd/Khalid Alkhrafy_edt_thumb.jpeg)
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Dr. Khalid Alkharfy,College of Pharmacy,
King Saud University,
Riyadh, Saudi Arabia. |
13:00-13:05 |
Session Introduction |
13:05-13:30
![khalid](thumbnails BIOBIO/march 2nd/Khalid Alkhrafy_edt_thumb.jpeg)
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Title: Biosimilar Products Selection: Challenges for Clinicians
Dr. Khalid Alkharfy,College of Pharmacy,
King Saud University,
Riyadh, Saudi Arabia.
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13:30-13:55 ![rfgwserg](images/thumbnails BIOBIO/march 2nd/Antonie Malek_edt_thumb.jpeg) |
Title: Drug Delivery in Pregnancy: Transport of Nanoparticles Across the Human Placenta and Fetal Exposure
Dr. Antoine Malek, University Hospital Zurich,
Department of Obstetrics,
Research Division,
Frauenklinikstr. 10,
8091 Zurich, Switzerland.
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13:55-14:20 |
Title: European Regulations in the Context of Biosimilars
Dr. Jean-Louis Prugnaud, Chef de Service,
Hôpital Saint-Antoine,
184 rue du Fbg Saint-Antoine,
Paris.
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14:20-14:45 |
Title: Biosimilars and CHMP EU Scientific Aadvice
Dr. Efthymios Manolis, Scientific Administrator,
Scientific Advice
Human - Pre Authorisation Evaluation,
EMEA,
7 Westferry Circus,
Canary Wharf,
London, UK.
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14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45 |
Title: Biosimilar of Epoetin Alfa: Issues on Comparability and Immumogenicity
Dr. Lucia Del Vecchio,
Department of Nephrology and Dialysis,
A. Manzoni Hospital, Lecco, Italy.
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16:45-17:10
![aseg](images/thumbnails BIOBIO/march 1st/joshep F.jpg)
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Title: Biosimilars and Follow-on Biologics
Dr. Fuhr Joseph P, Widener University, One University Place, Chester, PA 19013, USA.
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17:10-17:35 ![sf](images/thumbnails BIOBIO/march 1st/david goldsmith.jpg) |
Title: Biosimilar Epoetins in Europe - A Success Story?
Dr. David Goldsmith, Renal Unit, New Guy House,
Guy's Hospital, London, UK.
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17:35-18:00 |
Panel Discussion |
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![](images/gsblogo.jpg)
GSB Life Sciences, USA
![](images/Stanford_University_School_of_Medicine.jpg)
Stanford University School of Medicine, USA
![](images/Cairo_University.jpg)
Cairo University, Egypt
![](images/lscp.jpg)
Lord Shiva College of Pharmacy, India
![](images/Kazusa_DNA_Research_Institute.jpg)
Kazusa DNA Research Institute, Japan
![](images/University_of_Edinburgh.gif)
University of Edinburgh, UK
![](images/University_at _Buffalo.gif)
University at Buffalo, USA |
March 2, 2010
(Tuesday)
8:30-12:00 |
Track 2-3: Biosimulation in BE Studies-Prediction Tools |
Session Chair:
![srinu](thumbnails BIOBIO/march 2nd/Srinubabu Gedela_edt_thumb.jpeg)
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Dr. Srinubabu Gedela,
Stanford University School of Medicine, USA. |
Session Co-Chair:
![xzdvzdv](thumbnails BIOBIO/march 2nd/Hany A. El-Shemy_edt_thumb.jpeg)
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Prof. Hany A. El-Shemy,
Director of Biotechnology Labs,
FARP,
Biochemistry and Molecular Biology,
Biochemistry Department,
Faculty of Agriculture,
Cairo University, 12613 Giza,
Egypt. |
8:30-8:35 |
Session Introduction |
9:00-9:25
![xzdvzdv](thumbnails BIOBIO/march 2nd/Hany A. El-Shemy_edt_thumb.jpeg)
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Title: In-Silico Selection of Natural Anti-leukaemia Compounds
Prof. Hany A. El-Shemy,
Director of Biotechnology Labs,
FARP,
Biochemistry and Molecular Biology,
Biochemistry Department,
Faculty of Agriculture,
Cairo University,
12613 Giza, Egypt.
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9:25-9:50 |
Title: In Silico Adme Prediction Using QSPR Studies
Dr. Yash Paul Singla,
Principal,
Lord Shiva College of Pharmacy,
P.B. No.63, Near Civil Hospital,
Sirsa-125055, Haryana, India.
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9:50-10:15 ![;pijno](images/thumbnails BIOBIO/march 1st/hsinyun.jpg) |
Dr. Hsin-Yun HSU,
Laboratory of Medical Genomics,
Department of Human Genome Research,
Kazusa DNA Research Institute,
Kisarazu, Chiba, Japan.
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10:15-10:25 |
Coffee Break |
10:25-10:50 ![sweg](images/thumbnails BIOBIO/march 1st/goltsov.jpg) |
Dr. Alexey Goltsov,
Centre for Systems Biology of Edinburgh,
School of Biological Sciences,
University of Edinburgh,
The Kings Buildings, Mayfield Road,
Edinburgh, EH9 3JU, UK.
|
10:50-11:15 ![dvsve](images/thumbnails BIOBIO/march 1st/sathy_balulyer.jpg) |
Title: Drug Delivery System for Proteins and Biosimilars
Dr. Sathy V. Balu-Iyer, Associate Professor,
Department of Pharmaceutical Sciences, 521 Hochstetter Hall,
University at Buffalo, State University of New York,
Amherst, New York, USA.
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11:40-12:00 |
Panel Discussion |
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|
![](images/Chungnam_National_University.JPG)
Chungnam National University, Korea
![](images/Eli_Lilly.jpg)
Eli Lilly and Company, USA
Synchron Research Services Pvt. Ltd., India
|
March 2, 2010
(Tuesday)
13:00-18:00 |
Track 2-4: Statistical Issues in BA/BE |
Session Chair: ![egsehg](thumbnails BIOBIO/march 2nd/Kwang Li-Kwon (2)_edt_thumb.jpeg) |
Prof. Kwang-il Kwon, College of Pharmacy,
Chungnam National University,
Daejeon,
Korea. |
Session Co-Chair:![egfa](thumbnails BIOBIO/march 2nd/Ying Grace li 2_edt_thumb.jpeg) |
Ms. Ying Grace Li, Project Statistician
Statistics-AI/ MSK/ CC/ CV,
Eli Lilly and Company,
Lilly Corporate Center, Indianapolis, IN 46285, USA. |
13:00-13:05 |
Session Introduction |
13:05-13:30
![egsehg](thumbnails BIOBIO/march 2nd/Kwang Li-Kwon (2)_edt_thumb.jpeg)
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Title: Bioequivalence Methods for Assessment of Highly
Variable Drug – ABE, SABE, PBE and IBE
Prof. Kwang-il Kwon, College of Pharmacy,
Chungnam National University,
Daejeon,
Korea.
|
13:55-14:20
![egfa](thumbnails BIOBIO/march 2nd/Ying Grace li 2_edt_thumb.jpeg)
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Title: The Application of Bayesian/Frequentist Analysis in Bioequivalence/Bioavailability Studies
Ms. Ying Grace Li, Project Statistician,
Statistics-AI/ MSK/ CC/ CV,
Eli Lilly and Company,
Lilly Corporate Center, Indianapolis, IN 46285, USA.
|
14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45 ![srdh](thumbnails BIOBIO/march 2nd/Shubha Rani_edt_thumb.jpeg) |
Title: Sparse Sampling Strategies in Pharmacokinetics and Bioequivalence
Dr. Shubha Rani,
Technical Director & Head - Biometrics and Data Management,
Synchron Research Services Pvt. Ltd.,
'The chambers',
3rd Floor,
Bodakdev, SG Highway,
Ahmedabad, India.
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17:35-18:00 |
Panel Discussion |
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|
![](images/Rhodes_University.JPG)
Rhodes University,
South Africa
![](images/Harvard_Medical.gif)
Harvard Medical School, USA
![](images/cadila-logo_01.jpg)
Cadila Pharmaceuticals Limited, India
![](images/University_of_Trieste.jpg)
University of Trieste, Italy
![](images/logouoh.gif)
University of Hyderabad,
India
|
March 2, 2010
(Tuesday)
8:30-12:00 |
Track 2-5: In Vivo/In Vitro Methods to Determine Bioavailability |
Session Chair:
![isdore](thumbnails BIOBIO/march 2nd/Isadore Kanfer (2)_edt_thumb.jpeg)
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Dr. Isadore Kanfer, Emeritus Professor,
Faculty of Pharmacy,
Rhodes University,
Grahamstown, South Africa. |
Session Co-Chair: |
Dr. Luis Pereira, Associate Professor,
Pharmacometrics MCPHS, Childrens' Hospital Boston,
Harvard Medical School, Boston, MA, USA. |
8:30-8:35 |
Session Introduction |
9:25-9:50
![nbnvn](thumbnails BIOBIO/march 2nd/Dr. Bhaswat S. Chakraborty.jpg)
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Title: Average, Individual and Population Bioequivalence – Understanding the True Variability of a Product
Dr. Bhaswat S. Chakraborty , Sr. Vice President, R&D,
Cadila Pharmaceuticals, India.
|
9:50-10:15 ![rg](images/thumbnails BIOBIO/march 1st/SabinaP.jpg) |
Title: Bioavailability of Flavonoids: In Vitro Methods for Assessing Bilitranslocase-Mediated Membrane Transport
Dr. Sabina Passamonti, University of Trieste,
Department of Life Sciences, via L. Giorgieri 1, 34127 Trieste,
Italy.
|
10:15-10:25 |
Coffee Break |
10:25-10:50 |
Title: Quantitation of Alpha Amyrin in Scoparia dulcis L. Whole Plant Extract by High Performance Liquid Chromatography
Dr. Kishore Kumar Kadimpati,
Dept. Of Plant Sciences,
School of Life Sciences,
University of Hyderabad,
Gochibowli,
Hyderabad, India.
|
10:50-11:15
![isdore](thumbnails BIOBIO/march 2nd/Isadore Kanfer (2)_edt_thumb.jpeg)
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Title: Application of Dermal Microdialysis for the Determination of Bioavailability/Bioequivalence of Topical Drug Products Not Intended for Systemic Circulation
Dr. Isadore Kanfer, Emeritus Professor,
Faculty of Pharmacy,
Rhodes University,
Grahamstown, South Africa.
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11:15-11:40 |
Dr. Luis Pereira, Associate Professor,
Pharmacometrics MCPHS, Childrens' Hospital Boston,
Harvard Medical School, Boston, MA, USA.
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11:40-12:00 |
Panel Discussion |
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|
![](images/piilogo.jpg)
Pharmaceutics International, Inc, USA
![](images/Division_of_Product_Quality_Research.jpg)
Division of Product Quality Research, USA
![](images/MAHE_Manipal.jpg)
College of Pharmaceutical Sciences, India
![](images/C.U.jpg)
Shreemati Nathibai Damodar Thackersey Women's University, India
![](images/Maharashtra.jpg)
Maharashtra Institute of Pharmacy, India
|
March 2, 2010
(Tuesday)
13:00-18:00 |
Track 2-6: Role of Drug Delivery Systems in Bioequivalence and Bioavailability |
Session Chair:
![praveen](thumbnails BIOBIO/march 2nd/Praveen S. Hiremath (3)_edt_thumb.jpeg)
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Dr. Praveen S. Hiremath, Pharmaceutics Int., Inc., USA. |
Session Co-Chair: ![sxdvb](images/thumbnails BIOBIO/march 2nd/Mansoor A. Khan (2)_edt_thumb.jpeg) |
Dr. Mansoor A. Khan,
Director, Division of Product Quality Research,
FDA/CDER/OPS/OTR,
White Oak, LS Building 64,
10903 New Hampshire Ave,
Silver Spring, MD, USA. |
13:00-13:05 |
Session Introduction |
13:05-13:30
![praveen](thumbnails BIOBIO/march 2nd/Praveen S. Hiremath (3)_edt_thumb.jpeg)
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Title: Role of Lipid Based Drug Delivery Systems in Bioavailability Enhancement
Dr. Praveen S. Hiremath,
Product Development,
Pharmaceutics International, Inc.,
10189 Gilroy Road,
Hunt Valley, MD, USA.
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13:30-13:55 ![sxdvb](images/thumbnails BIOBIO/march 2nd/Mansoor A. Khan (2)_edt_thumb.jpeg) |
Dr. Mansoor A. Khan,
Director, Division of Product Quality Research,
FDA/CDER/OPS/OTR,
White Oak, LS Building 64,
10903 New Hampshire Ave,
Silver Spring, MD, USA.
|
13:55-14:20 ![vsxdbv](images/thumbnails BIOBIO/march 1st/Udupa.jpg) |
Title: Bioavailability and Bioequivalence of Novel
Drug Delivery Systems
Dr. N. Udupa, Professor and Principal,
College of Pharmaceutical Sciences,
MAHE, Manipal, India.
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14:20-14:45 ![dxfbn](images/thumbnails BIOBIO/march 2nd/Khamalinder K. Singh_edt_thumb.jpeg) |
Title: Nanosuspensions for Improved Drug Bioavailability and Targeted Drug Delivery
Prof. Kamalinder.K.Singh,
Principal(Addl. Charge),
C.U.Shah College Of Pharmacy,
SNDT Women's University,
Santacruz (West),
Mumbai - 400049, India.
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14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45 |
Dr. Rajeev Raghuvanshi,
|
17:10-17:35 ![awef](images/thumbnails BIOBIO/march 1st/B_S_Kuchekar.jpg) |
Title: Enhancing Oral Bioavailabilty of Drugs Using Cyclodextrins
Dr. B.S.Kuchekar,
Maharashtra Institute of Pharmacy,
MIT Campus, Paud Road,
Kothrud, Pune. Maharashtra,
India.
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17:35-18:00 |
Panel Discussion |
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Track 3: Bioanalytical Methodology Development and Validation Using HPLC and LCMS |
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![](images/agilentlogo-home.jpg)
Agilent Technologies India Pvt. Ltd., India
![](images/Aizant_Drug.JPG)
Aizant Drug Research Solutions, India
![](images/cdri_01.gif)
Central Drug Research Institute, India
![](images/Athina.jpg)
University of Athens,
Greece
![](images/Jadavpur_University.gif)
Jadavpur University,
India
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Time |
Track |
March 2, 2010
(Tuesday)
8:30-12:00 |
Track 3-1: Advances in Mass Spectrometry Methodology Development |
Session Chair:
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Dr. Ajit Srivastava
Business Manager - LCMS,
Agilent Technologies India Pvt. Ltd,
Plot No 10, Udyog Vihar, Phase IV, Gurgaon – 122016, India. |
Session Co-Chair:![seg](thumbnails BIOBIO/march 2nd/Ravi Shankar_edt_thumb.jpeg) |
Dr. S. Ravisankar, PhD, MBA,
Director, Quality Assurance, Clinical Development,
GVK Biosciences Pvt Ltd, India. |
8:30-8:35 |
Session Introduction |
8:35-9:00 ![seg](images/thumbnails BIOBIO/march 2nd/Ravi Shankar_edt_thumb.jpeg) |
Title: Recent Developments in Bioanalytical Method Validation Requirements for Mass Spectrometric Methods
Dr. S. Ravisankar, PhD, MBA,
Director, Quality Assurance, Clinical Development,
GVK Biosciences Pvt Ltd, India.
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9:00-9:25
![ajith](thumbnails BIOBIO/march 2nd/Ajit Srivasthav_edt_thumb.jpeg)
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Dr. Ajit Srivastava
Business Manager - LCMS,
Agilent Technologies India Pvt. Ltd,
Plot No 10, Udyog Vihar, Phase IV, Gurgaon – 122016, India.
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9:25-9:50 |
Title: Bioanalytical Method Transfer: Challenges and Recent Developments
Dr.Yarramraju Sitaramaraju, Associate director,
Clinical Development,
Aizant Drug Research Solutions P. Ltd.,
Hyderabad, India.
|
9:50-10:15 ![dv](thumbnails BIOBIO/march 1st/girish.gif) |
Title: Ion Trap as a Tool for In-vitro and In-vivo Metabolite Profiling
Dr. Girish kumar jain,
Head, Division of Pharmacokinetics & Metabolism,
Central Drug Research Institute,
Lucknow-226001, India.
|
10:15-10:25 |
Coffee Break |
10:50-11:15 |
Title: Bioanalytical Methodology Development and Validation Using HPLC and LCMS-Advances in Mass Spectrometry Methodology Development
Dr. Constantinos Pistos, Lecturer of Toxicology,
Laboratory of Forensic Medicine and Toxicology,
Medical School,
University of Athens,
Greece.
|
11:15-11:40 ![zdxvbv](thumbnails BIOBIO/march 1st/sangeeta.jpg) |
Title: Bioanalytical Method Development of the Metabolite 3-desmethylthiocolchicine in Human Plasma by LC-MS/MS
Dr. Sangita Agarwal, Women Scientist-DST,
Dept. of Pharm. Tech.,
Jadavpur University,
Kolkata, India.
|
11:40-12:00 |
Panel Discussion |
|
|
![](images/Universiade.jpg)
Universiade Federal da Bahia, Brazil
![](images/Defence Research and Development Canada.jpg)
Defence Research and Development, Canada
![](images/Cairo_University.jpg)
Cairo University, Egypt
![](images/cariri.jpg)
University of Region of Cariri, Brazil
![](images/cdri_01.gif)
Central Drug Research Institute, India
![](images/Tabriz_University.gif)
Tabriz University of Medical Sciences, Iran
|
March 2, 2010
(Tuesday)
13:00-18:00 |
Track 3-2: Antiviral, Anti Retroviral, Antibacterial and Anti Fungal Drugs |
Session Chair: |
Call for Host |
Session Co-Chair: |
Call for Co-Host |
13:00-13:05 |
Session Introduction |
13:05-13:30 |
Dr. Silvia Lima Costa,
Laboratorio de Neuroquimica e Biologia Celular,
Universiade Federal da Bahia,
Instituto de Ciências da Saude, Brazil.
|
13:30-13:55
![vcvcv](thumbnails BIOBIO/march 2nd/Jonathan P. Wong (2)_edt_thumb.jpeg)
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Title: Protection against Seasonal and Avian Influenza Virus Infections Using Nucleic Acid-Based Antiviral Agents
Dr. Jonathan P. Wong, Defence Scientist,
Defence Research and Development Canada, Suffield,
CP 4000, Succ. Main, Medicine Hat, Alberta, Canada.
|
13:55-14:20
![vcv](thumbnails BIOBIO/march 2nd/Emad A. Shalaby (2)_edt_thumb.jpeg)
|
Title: Biochemical and Biological Studies on Salt Stressed Spirulina Platensis
Dr. Emad A. Shalaby,
Biochemistry Department, Faculty of Agriculture and
Botany Department, Faculty of Science, Cairo University,
Giza, Egypt.
|
14:20-14:45 |
Title: The Necessity of New Sinergistic Formulations to Combat the Drug Resistance
Dr. Henrique Douglas Coutinho,
Laboratory of Microbiology and Molecular Biology,
Depart. of Biological Sciences,
University of Region of Cariri - URCA,
AV. Cel Antonio Luiz,
Crato (CE), Brazil.
|
14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45
![jawha](thumbnails BIOBIO/march 2nd/Jawahar lal (2)_edt_thumb.jpeg)
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Title: Standardization of Herbal Drug Preparations using LC-MS
Dr. Jawahar Lal, Scientist E-II,
Pharmacokinetics & Metabolism Division,
Central Drug Research Institute, CSIR,
Lucknow, India.
|
16:45-17:10 |
Dr. Mohammadreza Ghandforoush-Sattari,
Assistant Professor of Clinical Toxicology,
Dept.Pharmacology & Toxicology,
Faculty of Pharmacy,
Tabriz University of Medical Sciences,
Tabriz,
Iran.
|
17:35-18:00 |
Panel Discussion |
|
|
![](images/Hopital_Cochin.jpg)
Hopital Cochin, Paris
![](images/johns_hopkins_medicine.jpg)
Johns Hopkins University, USA
![](images/Einstein_Heart _nd_Vascular_Institute.jpg)
Albert Einstein Medical Center, USA
![](images/Yeditepe_University.jpg)
Yeditepe University, Turkey
|
March 2, 2010
(Tuesday)
8:30-12:00 |
Track 3-3: Drugs Acting on Central Nervous Systems |
Session Chair: |
Call for Host |
Session Co-Chair: |
Dr. Raphael Serreau, MD,
Responsable Appel d'Offre - PV,
URC Paris Necker-Cochin- EA 3620,
Hopital Cochin, Paris. |
8:30-8:35 |
Session Introduction |
8:35-9:00 |
Title: Bioequivalence of generic antiepilepsy drugs
Dr. Gregory Krauss, MD,
Professor of Neurology,
Johns Hopkins University,
Baltimore, MD, USA.
|
9:25-9:50
![bvb](thumbnails BIOBIO/march 2nd/Raphel Sereeau_edt_thumb.jpeg)
|
Title: Codeine and Breastfeeding, What are the Latest Data in Pharmacovigilance and EMEA Regulation
Dr. Raphael Serreau, MD,
Responsable Appel d'Offre - PV,
URC Paris Necker-Cochin- EA 3620,
Hopital Cochin, Paris.
|
9:50-10:15 |
Dr. S. Chattopadhyay
|
10:15-10:25 |
Coffee Break |
10:50-11:15 |
Dr. Darshak Karia, MD,
Director, Heart Failure Services,
Einstein Heart and Vascular Institute,
Levy 3 East,
Albert Einstein Medical Center,
Philadelphia, USA.
|
11:15-11:40 |
Title: Clinical Study of the Bioequivalence of Trimetazidine Immediate Release and Modified Release Tablets
Dr. Dilek Erol, Yeditepe University, Faculty of Pharmacy, 34755 Kayısdagı, Istanbul, Turkey.
|
11:40-12:00 |
Panel Discussion |
|
|
![](images/logouoh.gif)
University of Hyderabad,
India
![](images/btnrh_logo.png)
Boys Town National Research Hospital, USA
![](images/V.L.College.jpg)
V.L. College of Pharmacy, India
![](images/University_of_Wisconsin.png)
University of Wisconsin-Whitewater, USA
![](images/University_of_Nebraska_Medical_Center.jpg)
University of Nebraska Medical Center, USA
![](images/Creighton_University_Medical_Center.jpg)
Creighton University Medical Center, USA
![](images/Osmania.jpg)
Osmania University, India
|
March 2, 2010
(Tuesday)
13:00-18:00 |
Track 3-4: Anticancer/Anti-Neovascular Drugs |
Session Chair:
![vbvb](thumbnails BIOBIO/march 2nd/Reddanna P (2)_edt_thumb.jpeg)
|
Prof. P. Reddanna,
Eicosanoids,
Inflammation & Cancer Research Group,
School of Life Sciences, University of Hyderabad, Hyderabad, India. |
Session Co-Chair:
![bvb](thumbnails BIOBIO/march 2nd/Sudhakar Akulapalli_edt_thumb(1).jpeg)
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Dr. Sudhakar Akulapalli,
Creighton University Medical Center and University of Nebraska Medical Center.
Director & Coordinator: Cell Signaling and Tumor Angiogenesis Laboratory,
Boys Town National Research Hospital,
Omaha, USA. |
13:00-13:05 |
Session Introduction |
13:05-13:30
![b vb](thumbnails BIOBIO/march 2nd/Mayur Yergeri_edt_thumb.jpeg)
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Title: Design of New Drug Molecules to be Used
in Reversing Multidrug Resistance in Cancer Cells
Prof. Mayur Yergeri,
Department of Medicinal Chemistry,
V.L. College of Pharmacy,
Raichur, India.
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13:30-13:55
![bnb](thumbnails BIOBIO/march 2nd/Sudhakar Akulapalli 1_edt_thumb.jpeg)
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Title: Signaling Mechanisms of Endogenous Anti-cancer Molecules Derived From Extra Cellular Matrix Type IV Collagen
Dr. Sudhakar Akulapalli,
Creighton University Medical Center and University of Nebraska Medical Center.
Director & Coordinator: Cell Signaling and Tumor Angiogenesis Laboratory,
Boys Town National Research Hospital,
Omaha, USA.
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13:55-14:20 |
Title: Expanding Applications for Use of Biologically Modified Nanoparticles in Cancer Research
Dr. Eric Michael Bratsolias Brown,
Assistant Professor,
Department of Biological Sciences,
University of Wisconsin-Whitewater,
Upham Hall,
800 W. Main St.,
Whitewater, WI 53190, USA.
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14:20-14:45
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Title: Imatinib Resistance in Chronic Myeloid Leukemia:
Role of COX-2, MDR-1 and HDACs
Prof. P. Reddanna,
Eicosanoids,
Inflammation & Cancer Research Group,
School of Life Sciences, University of Hyderabad, Hyderabad, India.
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14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45
![kollu](thumbnails BIOBIO/march 2nd/Kolluru Ramaiah (2)_edt_thumb.jpeg)
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Title: Phosphorylation of eIF2α-Mediated Signalling Pathways in Cell Survival and Suicide
Prof. Kolluru VA Ramaiah,
Dept of Biochemistry,
School of Life Sciences, University of Hyderabad
Hyderabad,
India.
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16:45-17:10
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Title: Differential Regulation of HIF-1α under Normoxic and Hypoxic Conditions
Dr. Surya S. Singh, Dept. of Biochemistry,
Osmania University, Hyderabad, India.
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17:35-18:00 |
Panel Discussion |
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Track 4: IP, Regulatory Affairs and Outsourcing Alliance |
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![](images/cherubino_pan_Logo.gif)
University of Pisa, Italy
![](images/KLE_University.jpg)
KLE University, India
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March 2, 2010
(Tuesday)
13:00-18:00 |
Track 4-1: ICH/FDA Guidelines and Regulatory Updates |
Session Chair: |
Prof. Mario Giorgi, Pharmacology & Toxicology Section,
University of Pisa,
V.le delle Piagge 2,
56124 Pisa, Italy. |
Session Co-Chair:
![basava](thumbnails BIOBIO/march 2nd/Basavraj K. Nanjwade (2)_edt_thumb.jpeg)
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Prof. Basavaraj K. Nanjwade,
Department of Pharmaceutics,
JN Medical college,
KLE University,
Belgaum- 590010,
Karnataka,
India. |
13:00-13:05 |
Session Introduction |
13:30-13:55
![mario](thumbnails BIOBIO/march 2nd/Mario Giorgi (2)_edt_thumb.jpeg)
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Title: PK-PD integration/modeling of NSAID in Veterinary Pharmacology
Prof. Mario Giorgi, Pharmacology & Toxicology Section,
University of Pisa,
V.le delle Piagge 2,
56124 Pisa, Italy.
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14:45-16:20 |
Coffee Break & Poster Session |
16:20-16:45![basava](thumbnails BIOBIO/march 2nd/Basavraj K. Nanjwade (2)_edt_thumb.jpeg)
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Title: Regulatory Requirements for Orphan Drugs Delivery
Prof. Basavaraj K. Nanjwade,
Department of Pharmaceutics,
JN Medical college,
KLE University,
Belgaum- 590010,
Karnataka, India.
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17:35-18:00 |
Panel Discussion |
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![](images/ra_chem_pharma.jpg)
Clinical Research and Biosciences division, India
![](images/Raptakos_Brett.jpg)
Raptakos, Brett & Co. Ltd., India
![](images/PharMantra.jpg)
PharMantra Consulting Solutions, India
![](images/Islamia_University.JPG)
The Islamia University of Bahawalpur, Pakistan
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March 2, 2010
(Tuesday)
13:00-18:00 |
Track 4-2: Perspectives of Regulatory Agencies, Worldwide, on Bioequivalence Testing |
Session Chair: |
Ms. Neerja S,
Dy. Manager, QA,
RA Chem Pharma Ltd,
Clinical Research and Biosciences division,
C3 (A) HUDA complex,
Tarnaka, Hyderabad, India. |
Session Co-Chair: |
Dr. Pralhad Tayade, DGM Contract Research,
Raptakos Brett & Co.,
Mumbai, India. |
13:00-13:05 |
Session Introduction |
13:05-13:30
![rajini](thumbnails BIOBIO/march 2nd/Rajani Nellore (2)_edt_thumb.jpeg)
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Title: Assuring Bioequivalence: Pilot Studies or Dissolution?
Dr. Ranjani Nellore, RAC,
PharMantra Consulting Solutions,
Hyderabad, India.
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13:30-13:55 |
Title: Challenges for Preparation of Module 2 & 5 for BA/ BE for US & EMEA
Ms. Neerja S,
Dy. Manager, QA,
RA Chem Pharma Ltd,
Clinical Research and Biosciences division,
C3 (A) HUDA complex,
Tarnaka, Hyderabad, India.
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14:20-14:45 |
Title: What Should be Indian Pharma R&D’s Focus Areas in 2010
Dr. Pralhad Tayade, DGM Contract Research,
Raptakos Brett & Co.,
Mumbai, India.
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14:45-16:20 |
Coffee Break & Poster Session |
16:45-17:10 |
Title: In-Vitro Release and Pharmacokinetics of Anti-tubercle
Drug Ethionamide in Healthy Male Subjects
Prof. Mahmaood Ahmad,
Dean, Faculty of Pharmacy and Alternative Medicine,
The Islamia University of Bahawalpur,
Punjab, Pakistan.
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17:35-18:00 |
Panel Discussion |
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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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