Publications by authors named "Richard Burdick"

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Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products.
Richard Burdick, Jeff Hofer, Andrew Karl, Heath Rushing

AAPS J· September 2024

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Comparison of Analytical Procedures in Method Transfer and Bridging Experiments.
Richard K Burdick

AAPS J· July 2023

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The Goldilocks Challenge-Controlling Uncertainty When Setting Product Specifications.
Richard K Burdick, Julia C O'Neill

PDA J Pharm Sci Technol· June 2021

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PDA Biosimilars Workshop Report (September 27-28, 2018)-Getting It Right the First Time for Biosimilar Marketing Applications.
Stephan Krause, Emanuela Lacana, Joel Welch, Marjorie Shapiro, Christopher Downey, Richard Burdick

PDA J Pharm Sci Technol· April 2020

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Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products.
Richard O Montes, Richard K Burdick, David J Leblond

PDA J Pharm Sci Technol· May 2019

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Precision of the reportable value-Statistical optimization of the number of replicates.
Richard K Burdick, Joachim Ermer

J Pharm Biomed Anal· January 2019

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On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.
Harry Yang, Steven Novick, Richard K Burdick

PDA J Pharm Sci Technol· May 2018

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Statistical Approaches to Assess Biosimilarity from Analytical Data.
Richard Burdick, Todd Coffey, Hiten Gutka, Gyöngyi Gratzl, Hugh D Conlon

AAPS J· January 2017

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Establishment of an equivalence acceptance criterion for accelerated stability studies.
Richard K Burdick, Leslie Sidor

J Biopharm Stat· February 2014

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Assessment of individual agreements with repeated measurements based on generalized confidence intervals.
Jorge Quiroz, Richard K Burdick

J Biopharm Stat· June 2009

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Assessing equivalence of two assays using sensitivity and specificity.
Jorge Quiroz, Richard K Burdick

J Biopharm Stat· June 2007

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Controlled-release oxycodone.
Alan M Levine, Richard K Burdick

J Am Acad Orthop Surg· May 2005

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Neoadjuvant chemoradiation to convert locally advanced pancreatic body adenocarcinoma to resectable disease.
Steven C Cunningham, Mike Cusnir, Richard K Burdick, David A Van Echo, Robert Moesinger

Clin Adv Hematol Oncol· December 2003

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Alternative confidence intervals for the assessment of bioequivalence in four-period cross-over designs.
Jorge Quiroz, Naitee Ting, Greg C G Wei, Richard K Burdick

Stat Med· July 2002

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