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Co-authors
(48)
Vinod P. Shah
4
Robert Temple
4
Bertil Abrahamsson
4
Paul Fackler
4
Lawrence X. Yu
4
Journals
(5)
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2
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Authors
Helen N. Winkle
Helen N. Winkle,Pharmacology,Biotechnology,Neuroscience
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Helen N. Winkle
Publications:
6
|
Citations:
63
Fields:
Pharmacology
,
Biotechnology
,
Neuroscience
View FAQ about top research areas and Fields of study
Collaborated with
48 co-authors
from 2007 to 2010
|
Cited by
190 authors
Cumulative
Annual
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Publications
(6)
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RefWorks
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Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: Workshop summary report
(
Citations: 4
)
Mei-Ling Chen
,
Vinod P. Shah
,
Derek Ganes
,
Kamal K. Midha
,
James Caro
,
Prabu Nambiar
,
Mario L. Rocci Jr.
,
Avinash G. Thombre
,
Bertil Abrahamsson
,
Dale Conner
,
Barbara Davit
,
Paul Fackler
Helen Winkle
http://academic.research.microsoft.com/io.ashx?type=5&id=35991811&selfId1=11370109&selfId2=0&maxNumber=12&query=
Journal:
European Journal of Pharmaceutical Sciences - EUR J PHARM SCI
, vol. 40, no. 2, pp. 148-153, 2010
Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report
Mei-Ling Chen
,
Vinod P. Shah
,
Derek Ganes
,
Kamal K. Midha
,
James Caro
,
Prabu Nambiar
,
Mario L. Rocci
,
Avinash G. Thombre
,
Bertil Abrahamsson
,
Dale Conner
,
Barbara Davit
,
Paul Fackler
Helen Winkle
http://academic.research.microsoft.com/io.ashx?type=5&id=49186310&selfId1=11370109&selfId2=0&maxNumber=12&query=
Journal:
Clinical Therapeutics - CLIN THER
, vol. 32, no. 10, pp. 1704-1712, 2010
Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report
Mei-Ling Chen
,
Vinod P. Shah
,
Derek Ganes
,
Kamal K. Midha
,
James Caro
,
Prabu Nambiar
,
Mario L. Rocci Jr
,
Avinash G. Thombre
,
Bertil Abrahamsson
,
Dale Conner
,
Barbara Davit
,
Paul Fackler
Helen Winkle
http://academic.research.microsoft.com/io.ashx?type=5&id=38666076&selfId1=11370109&selfId2=0&maxNumber=12&query=
Journal:
Aaps Journal - AAPS J
, vol. 12, no. 3, pp. 371-377, 2010
Quality by design for biopharmaceuticals
(
Citations: 23
)
Anurag S Rathore
,
Helen Winkle
Journal:
Nature Biotechnology - NAT BIOTECHNOL
, vol. 27, no. 1, pp. 26-34, 2009
Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond
(
Citations: 2
)
James E. Polli
,
Bertil S. I. Abrahamsson
,
Lawrence X. Yu
,
Gordon L. Amidon
,
John M. Baldoni
,
Jack A. Cook
,
Paul Fackler
,
Kerry Hartauer
,
Gordon Johnston
,
Steve L. Krill
,
Robert A. Lipper
,
Waseem A. Malick
Helen N. Winkle
http://academic.research.microsoft.com/io.ashx?type=5&id=38665951&selfId1=11370109&selfId2=0&maxNumber=12&query=
Journal:
Aaps Journal - AAPS J
, vol. 10, no. 2, pp. 373-379, 2008
Sort by:
Citations
(63 times by 61 publications)
Pharmacokinetic Similarity of Biologics: Analysis Using Nonlinear Mixed-Effects Modeling
A Dubois
,
S Gsteiger
,
S Balser
,
E Pigeolet
,
J L Steimer
,
G Pillai
,
F Mentré
Journal:
Clinical Pharmacology & Therapeutics - CLIN PHARMACOL THER
, vol. 91, no. 2, pp. 234-242, 2012
Complex Drugs and Biologics: Scientific and Regulatory Challenges for Follow-on Products
J. Michael Nicholas
Journal:
Drug Information Journal - DRUG INF J
, vol. 46, no. 2, pp. 197-206, 2012
Quality by Design in the Secondary Drying Step of a Freeze-Drying Process
Roberto Pisano
,
Davide Fissore
,
Antonello A. Barresi
Journal:
Drying Technology - DRY TECHNOL
, vol. 30, no. 11-12, pp. 1307-1316, 2012
PROCESS DEVELOPMENT FOR ROBUST REMOVAL OF AGGREGATES USING CATION EXCHANGE CHROMATOGRAPHY IN MONOCLONAL ANTIBODY PURIFICATION WITH IMPLEMENTATION OF QUALITY BY DESIGN
Zhihao Xu
,
Jason Li
,
Joe X. Zhou
Journal:
Preparative Biochemistry & Biotechnology - PREP BIOCHEM BIOTECHNOL
, vol. 42, no. 2, pp. 183-202, 2012
Transforming Regulatory Science 2012: Making a Difference
J L Goodman
Journal:
Clinical Pharmacology & Therapeutics - CLIN PHARMACOL THER
, vol. 91, no. 3, pp. 375-377, 2012
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