Harry Yang

发表

Setting Alert and Action Limits in the Presence of Significant Amount of Censoring in Data

Steven J Novick, Steven J. Novick, Wei Zhao, 2016, PDA Journal of Pharmaceutical Science and Technology.

A Novel Bayesian Method for Efficacy Assessment in Animal Oncology Studies

Steven J Novick, Steven J. Novick, C. Leow, 2018 .

Bayesian Tolerance Intervals for Zero-Inflated Data with Applications in Pharmaceutical Quality Control

Binbing Yu, Harry Yang, Pin Ren Jul, 2019 .

Biosimilars

Harry Yang, H. Gutka, S. Kakar, 2018, AAPS Advances in the Pharmaceutical Sciences Series.

Acceptance Sampling Plans by Attributes

Harry Yang, D. Carlin, 2001 .

Clinical Trial Simulation To Assist In COPD Trial Planning And Design With A Biomarker-Based Diagnostic: When To Pull The Trigger?

Harry Yang, J. Parker, D. Gossage, 2014, COPD.

Tolerance Limits for a Ratio of Normal Random Variables

T. Mathew, K. Krishnamoorthy, Lanju Zhang, 2009, Journal of biopharmaceutical statistics.

An electrochemiluminescence (ECL)-based assay for the specific detection of anti-drug antibodies of the IgE isotype.

R. Woods, W. White, P. Chowdhury, 2013, Journal of pharmaceutical and biomedical analysis.

Establishing Acceptable Limits of Residual DNA

Harry Yang, 2013, PDA Journal of Pharmaceutical Science and Technology.

Drug Combination Synergy

Steven J Novick, Steven J. Novick, Wei Zhao, 2014 .

Time and out-of-pocket costs associated with respiratory syncytial virus hospitalization of infants.

J. Marcin, J. Devincenzo, Harry Yang, 2003, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

Immunogenicity assay cut point determination using nonparametric tolerance limit.

L. Roskos, Harry Yang, Jianchun Zhang, 2017, Journal of immunological methods.

A Statistical Approach to Determining Criticality of Residual Host Cell DNA

M. Schenerman, Harry Yang, Ziping Wei, 2015, Journal of biopharmaceutical statistics.

A new stochastic approach to multi-compartment pharmacokinetic models: probability of traveling route and distribution of residence time in linear and nonlinear systems

Harry Yang, Liang Zhao, Na Li, 2011, Journal of Pharmacokinetics and Pharmacodynamics.

Directly testing the linearity assumption for assay validation

Steven J. Novick, Harry Yang, 2013 .

Analytical Methods

Steve Novick, Harry Yang, 2018, Bayesian Analysis with R for Drug Development.

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

Harry Yang, Harry Yang, 2013, PDA Journal of Pharmaceutical Science and Technology.

Multivariate Mixed-Effects Kinetic Models for Multiple Correlated Quality Attributes From Accelerated Stability Studies

Binbing Yu, Harry Yang, Lingmin Zeng, 2019, Statistics in Biopharmaceutical Research.

Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

Harry Yang, Binbing Yu, Lingmin Zeng, 2017, Biologicals : journal of the International Association of Biological Standardization.

Generalized ROC methods for immunogenicity data analysis of vaccine phase I studies in a seropositive population

J. Falloon, M. Esser, Harry Yang, 2018, Human vaccines & immunotherapeutics.

ROC SURFACE: A GENERALIZATION OF ROC CURVE ANALYSIS

Harry Yang, H Yang, D Carlin, 2000, Journal of biopharmaceutical statistics.

A New Bliss Independence Model to Analyze Drug Combination Data

Lanju Zhang, Harry Yang, R. Hollingsworth, 2014, Journal of biomolecular screening.

Process Development

Steve Novick, Harry Yang, 2019, Bayesian Analysis with R for Drug Development.

Safety Profile and Clinical Outcomes in a Phase I, Placebo-Controlled Study of Siplizumab in Acute Graft-Versus-Host Disease

D. Adkins, Harry Yang, B. White, 2009, Transplantation.

Testing Assay Linearity Over a Pre-Specified Range

Steven J. Novick, D. Leblond, Harry Yang, 2015, Journal of biopharmaceutical statistics.

Effect of a statistical outlier in potency bioassays

Bruno Boulanger, Binbing Yu, Steven J. Novick, 2018, Pharmaceutical statistics.

Statistical Models for the Analysis of Isobaric Tags Multiplexed Quantitative Proteomics.

Harry Yang, Raghothama Chaerkady, Wendy I White, 2017, Journal of proteome research.

A Bayesian Approach to Residual Host Cell DNA Safety Assessment

Harry Yang, Jianchun Zhang, Harry Yang, 2016, PDA Journal of Pharmaceutical Science and Technology.

A probabilistic model for risk assessment of residual host cell DNA in biological products.

Lanju Zhang, Harry Yang, M. Galinski, 2010, Vaccine.

A Method of Estimating and Comparing Volumes Under Receiver Operating Characteristic (ROC) Surfaces

Harry Yang, Liang Zhao, 2010 .

A Risk-based Approach to Setting Sterile Filtration Bioburden Limits

Harry Yang, Na Li, S. Chang, 2013, PDA Journal of Pharmaceutical Science and Technology.

amounts of censoring in data Setting Alert and Action limits in the presence of significant

Steven J. Novick, Wei Zhao, Harry Yang, 2016 .

Statistical Methods for Immunogenicity Assessment

Harry Yang, Jianchun Zhang, Binbing Yu, 2015 .

A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes

Harry Yang, Binbing Yu, Lingmin Zeng, 2018, Statistics in Biopharmaceutical Research.

Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation

Harry Yang, Binbing Yu, Binbing Yu, 2017, PDA Journal of Pharmaceutical Science and Technology.

Dissolution Curve Comparisons Through the F2 Parameter, a Bayesian Extension of the f2 Statistic

Steven J. Novick, John J. Peterson, D. Leblond, 2015, Journal of biopharmaceutical statistics.

In Vitro Dissolution Curve Comparisons: A Critique of Current Practice

Steven J Novick, Steven J. Novick, John J. Peterson, 2016 .

Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments.

Harry Yang, L. Roskos, Harry Yang, 2018, Journal of immunological methods.

Implementation of Parallelism Testing for Four-Parameter Logistic Model in Bioassays

Hyun Jun Kim, Lanju Zhang, Harry Yang, 2012, PDA Journal of Pharmaceutical Science and Technology.

Assessment A Bayesian Approach to Residual Host Cell DNA Safety

Harry Yang, Jianchun Zhang, 2016 .

Characterizing the Overall Derivatization of Conjugated Oligomeric Proteins

M. Wendeler, Christopher Thompson, Xiangyang Wang, 2017, PDA Journal of Pharmaceutical Science and Technology.

Statistical methods in drug combination studies

Harry Yang, Wei Zhao, Harry Yang, 2014 .

A note on the determination of non-inferiority margins with application in oncology clinical trials☆

Binbing Yu, Harry Yang, A. Sabin, 2019, Contemporary clinical trials communications.

Bayesian Analysis with R for Drug Development

Steven J. Novick, Harry Yang, Harry Yang, 2019 .

A probabilistic model for risk assessment of residual host cell DNA in biological products.

Lanju Zhang, Harry Yang, M. Galinski, 2010, Vaccine.

Dissolution Curve Comparisons Through the F2 Parameter, a Bayesian Extension of the f2 Statistic

Steven J Novick, John J. Peterson, D. Leblond, 2015, Journal of biopharmaceutical statistics.

Setting Specifications of Correlated Quality Attributes through Multivariate Statistical Modelling

Harry Yang, 2013, PDA Journal of Pharmaceutical Science and Technology.

Evaluations of Parallelism Testing Methods Using ROC Analysis

Lanju Zhang, Harry Yang, 2012 .

A New Bliss Independence Model to Analyze Drug Combination Data

R. Hollingsworth, Lanju Zhang, Wei Zhao, 2014, Journal of biomolecular screening.

Implications and Limitations of Reference Values and Historical Data for the Interpretation of Nonhuman Primate Toxicology Studies

Robert L. Hall, Harry Yang, Laura Richman, 2015 .

Test Homogeneity of Risk Difference Across Subgroups in Clinical Trials

Lanju Zhang, Harry Yang, Lanju Zhang, 2009, Journal of biopharmaceutical statistics.