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Shein-Chung Chow

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United States

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United States Food and Drug Administration

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Publications

TOP 3
Wanda Lakey; William Yancy; Lan-Yan Yang; Shein-Chung Chow; Charles Hicks
Short communication: from wasting to obesity: initial antiretroviral therapy and weight gain in HIV-infected persons.
Shein-Chung Chow
Assessing biosimilarity and interchangeability of biosimilar products.
Seung-Ho Kang; Shein-Chung Chow
Statistical assessment of biosimilarity based on relative distance between follow-on biologics.

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All Publications

2013: Wanda Lakey; William Yancy; Lan-Yan Yang; Shein-Chung Chow; Charles Hicks
Short communication: from wasting to obesity: initial antiretroviral therapy and weight gain in HIV-infected persons.
AIDS research and human retroviruses 2013;29(3):435-40.
2013: Shein-Chung Chow
Assessing biosimilarity and interchangeability of biosimilar products.
Statistics in medicine 2013;32(3):361-3.
2013: Seung-Ho Kang; Shein-Chung Chow
Statistical assessment of biosimilarity based on relative distance between follow-on biologics.
Statistics in medicine 2013;32(3):382-92.
2013: Shein-Chung Chow; Laszlo Endrenyi; Jun Wang; Peter A Lachenbruch
Scientific considerations for assessing biosimilar products.
Statistics in medicine 2013;32(3):370-81.
2013: Jun Yang; Nan Zhang; Shein-Chung Chow; Eric Chi
An adapted F-test for homogeneity of variability in follow-on biological products.
Statistics in medicine 2013;32(3):415-23.
2013: Nan Zhang; Shein-Chung Chow; Laszlo Endrenyi; Jun Yang; Eric Chi
Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics.
Statistics in medicine 2013;32(3):424-33.
2013: Laszlo Endrenyi; Chiann Chang; Shein-Chung Chow; Laszlo Tothfalusi
On the interchangeability of biologic drug products.
Statistics in medicine 2013;32(3):434-41.
2013: Jr-Rung Lin; Ya-Ching Lin; Chih-Hsi Chang; Shein-Chung Chow; Jen-pei LIU
Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
Statistics in medicine 2013;32(3):449-61.
2013: Shein-Chung Chow; Laszlo Endrenyi; Peter A Lachenbruch
Comments on the FDA draft guidance on biosimilar products.
Statistics in medicine 2013;32(3):364-9.
2013: Tsung-Cheng Hsieh; Lan-Yan Yang; Shein-Chung Chow; Eric Chi
The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics.
Statistics in medicine 2013;32(3):406-14.
2013: Shein-Chung Chow; Aijing Starr; Lan-Yan Yang; Shih-Ting Chiu
Statistical methods for assessing interchangeability of biosimilars.
Statistics in medicine 2013;32(3):442-8.
2012: Shein-Chung Chow; Chieh Chiang; Jen-pei LIU; Chin-Fu Hsiao
Statistical methods for bridging studies.
Journal of biopharmaceutical statistics 2012;22(5):903-15.
2012: John A Crump; Venance Maro; Anne B Morrissey; Godfrey S Mushi; Mtumwa S Mwako; Boniface N Njau; Habib O Ramadhani; L Barth Reller; Wilbrod Saganda; Lan-Yan Yang; Shein-Chung Chow; John A Bartlett
Bacteremic disseminated tuberculosis in sub-saharan Africa: a prospective cohort study.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2012;55(2):242-50.
2012: Shein-Chung Chow; Ralph Corey; Min Lin
On the independence of data monitoring committee in adaptive design clinical trials.
Journal of biopharmaceutical statistics 2012;22(4):853-67.
2012: Qingshu Lu; Siu-Keung Tse; Shein-Chung Chow; Min Lin
Analysis of time-to-event data with nonuniform patient entry and loss to follow-up under a two-stage seamless adaptive design with weibull distribution.
Journal of biopharmaceutical statistics 2012;22(4):773-84.
2012: Sin-Ho Jung; Shein-Chung Chow
On sample size calculation for comparing survival curves under general hypothesis testing.
Journal of biopharmaceutical statistics 2012;22(3):485-95.
2011: Megan E B Clowse; Susannah C Copland; John C Davis; Gary S Hoffman; Tsung-Cheng Hsieh; W Joseph McCune; Peter A Merkel; Ulrich Specks; Robert F Spiera; E William St Clair; John H Stone; Steven R Ytterberg; Nancy B Allen; Shein-Chung Chow
Ovarian reserve diminished by oral cyclophosphamide therapy for granulomatosis with polyangiitis (Wegener's).
Arthritis care & research 2011;63(12):1777-81.
2011: John A Crump; Coleen K Cunningham; Helmut C Diefenthal; John A Bartlett; Shein-Chung Chow; Susan C Morpeth; Anne B Morrissey; Levina J Msuya; Boniface N Njau; Habib O Ramadhani; Hugh Reyburn; Werner Schimana; John F Shao; Andrea V Shaw; Lan-Yan Yang; Grace D Kinabo
Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected children and infants in northern Tanzania.
Tropical medicine & international health : TM & IH 2011;16(7):830-7.
2011: Bin Cheng; Shein-Chung Chow
Assessing departure from dose linearity under a repeated measures incomplete block design.
Pharmaceutical statistics 2011;10(4):357-62.
2011: Lan-Yan Yang; Yunchan Chi; Shein-Chung Chow
Statistical inference for clinical trials with binary responses when there is a shift in patient population.
Journal of biopharmaceutical statistics 2011;21(3):437-52.
2011: Juan Li; Eric M Chi; Chunyao Feng; Shein-Chung Chow
Imputation method adjusted for covariates for nonrespondents in instruments with applications.
Journal of biopharmaceutical statistics 2011;21(2):342-54.
2011: John A Crump; Habib O Ramadhani; Anne B Morrissey; Wilbrod Saganda; Mtumwa S Mwako; Lan-Yan Yang; Shein-Chung Chow; Susan C Morpeth; Hugh Reyburn; Boniface N Njau; Andrea V Shaw; Helmut C Diefenthal; John F Shao; John A Bartlett; Venance P Maro
Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected adults and adolescents in northern Tanzania.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2011;52(3):341-8.
2010: Bin Cheng; Shein-Chung Chow
On flexibility of adaptive designs and criteria for choosing a good one--a discussion of FDA draft guidance.
Journal of biopharmaceutical statistics 2010;20(6):1171-7.
2010: Shein-Chung Chow
A note on special articles on adaptive clinical trial designs.
Journal of biopharmaceutical statistics 2010;20(6):1088-9.
2010: Jacqueline A Richmond; Donald E Bailey; Keyur Patel; Janet A Jezsik; Andrew Muir; Jr-Rung Lin; Shein-Chung Chow; Diane Uzarski; John G McHutchison
The use of complementary and alternative medicine by patients with chronic hepatitis C.
Complementary therapies in clinical practice 2010;16(3):124-31.
2010: Hsiao-Hui Tsou; Shein-Chung Chow; K K Gordon Lan; Jen-pei LIU; Mey Wang; Herng-Der Chern; low-tone ho; Chao A Hsiung; Chin-Fu Hsiao
Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials--Asian perspective.
Pharmaceutical statistics 2010;9(3):201-6.
2010: Qingshu Lu; Siu-Keung Tse; Shein-Chung Chow
Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.
Journal of biopharmaceutical statistics 2010;20(4):705-19.
2010: Scott M Palmer; Ajit P Limaye; Missy Banks; Dianne Gallup; Jeffrey Chapman; E Clinton Lawrence; Jordan Dunitz; Aaron Milstone; John Reynolds; Gordon L Yung; Kevin M Chan; Robert M Aris; Edward Garrity; Vincent Valentine; Jonathan McCall; Shein-Chung Chow; Robert Duane Davis; Robin Avery
Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial.
Annals of internal medicine 2010;152(12):761-9.
2010: Shein-Chung Chow; Qingshu Lu; Siu-Keung Tse; Eric Chi
Statistical methods for assessment of biosimilarity using biomarker data.
Journal of biopharmaceutical statistics 2010;20(1):90-105.
2010: Tsung-Cheng Hsieh; Shein-Chung Chow; Jen-pei LIU; Chin-Fu Hsiao; Eric Chi
Statistical test for evaluation of biosimilarity in variability of follow-on biologics.
Journal of biopharmaceutical statistics 2010;20(1):75-89.
2010: Shein-Chung Chow; Tsung-Cheng Hsieh; Eric Chi; Jun Yang
A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.
Journal of biopharmaceutical statistics 2010;20(1):31-45.
2010: Shein-Chung Chow; Jen-pei LIU
Statistical assessment of biosimilar products.
Journal of biopharmaceutical statistics 2010;20(1):10-30.
2009: Jen-pei LIU; Jr-Rung Lin; Shein-Chung Chow
Inference on treatment effects for targeted clinical trials under enrichment design.
Pharmaceutical statistics 2009;8(4):356-70.
2009: Qingshu Lu; Siu-Keung Tse; Shein-Chung Chow; Jun Yang
On assessing bioequivalence using genomic data with model misspecification.
Journal of biopharmaceutical statistics 2009;19(4):571-9.
2009: Siu Keung Tse; Shein-Chung Chow; Qingshu Lu; Dennis Cosmatos
Testing homogeneity of two zero-inflated Poisson populations.
Biometrical journal. Biometrische Zeitschrift 2009;51(1):159-70.
2009: Qingshu Lu; Shein-Chung Chow; Siu Keung Tse; Yunchan Chi; Lan Yan Yang
Sample size estimation based on event data for a two-stage survival adaptive trial with different durations.
Journal of biopharmaceutical statistics 2009;19(2):311-23.
2008: Shein-Chung Chow; Siu-Keung Tse; Min Lin
Statistical methods in translational medicine.
Journal of the Formosan Medical Association = Taiwan yi zhi 2008;107(12 Suppl):61-73.
2008: Shein-Chung Chow; Yi-Hsuan Tu
On Two-stage Seamless Adaptive Design in Clinical Trials.
Journal of the Formosan Medical Association = Taiwan yi zhi 2008;107(12 Suppl):52-60.
2008: Siu-Keung Tse; Shein-Chung Chow; Chunyan Yang
Statistical tests for one-way/two-way translation in translational medicine.
Journal of the Formosan Medical Association = Taiwan yi zhi 2008;107(12 Suppl):43-51.
2008: Bin Cheng; Shein-Chung Chow; David Burt; Dennis Cosmatos
Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables.
Journal of biopharmaceutical statistics 2008;18(3):494-501.
2008: Shein-Chung Chow; Bin Cheng; Dennis Cosmatos
On power and sample size calculation for QT studies with recording replicates at given time point.
Journal of biopharmaceutical statistics 2008;18(3):483-93.
2008: Shein-Chung Chow; Mark Chang
Adaptive design methods in clinical trials - a review.
Orphanet journal of rare diseases 2008;3():11.
2008: Jen-pei LIU; Shein-Chung Chow
Statistical issues on the diagnostic multivariate index assay for targeted clinical trials.
Journal of biopharmaceutical statistics 2008;18(1):167-82.
2007: Shein-Chung Chow; Jun Shao
Stability analysis for drugs with multiple active ingredients.
Statistics in medicine 2007;26(7):1512-7.
2007: Huaibao Feng; Jun Shao; Shein-Chung Chow
Adaptive group sequential test for clinical trials with changing patient population.
Journal of biopharmaceutical statistics 2007;17(6):1227-38.
2007: Mark Chang; Shein-Chung Chow
Analysis strategies for adaptive designs with multiple endpoints.
Journal of biopharmaceutical statistics 2007;17(6):1189-200.
2007: Shein-Chung Chow; Qingshu Lu; Siu-Keung Tse
Statistical analysis for two-stage seamless design with different study endpoints.
Journal of biopharmaceutical statistics 2007;17(6):1163-76.
2007: Qingshu Lu; Shein-Chung Chow; Siu-Keung Tse
Assessing the consistency of traditional Chinese medicine with multiple correlative active components.
Journal of biopharmaceutical statistics 2007;17(5):791-808.
2007: Hsiao-Hui Tsou; Chin-Fu Hsiao; Shein-Chung Chow; Lilly Yue; Yunling Xu; Shiowjen Lee
Mixed noninferiority margin and statistical tests in active controlled trials.
Journal of biopharmaceutical statistics 2007;17(2):339-57.
2007: Sin-Ho Jung; Shein-Chung Chow; Eric M Chi
A note on sample size calculation based on propensity analysis in nonrandomized trials.
Journal of biopharmaceutical statistics 2007;17(1):35-41; discussion 43.
2006: Bin Cheng; Shein-Chung Chow; Wei-Lun Su
On the assessment of dose proportionality: a comparison of two slope approaches.
Journal of biopharmaceutical statistics 2006;16(3):385-92.
2006: Mark Chang; Shein-Chung Chow; Annpey Pong
Adaptive design in clinical research: issues, opportunities, and recommendations.
Journal of biopharmaceutical statistics 2006;16(3):299-309; discussion 311-2.
2006: Shein-Chung Chow; Jun Shao
On non-inferiority margin and statistical tests in active control trials.
Statistics in medicine 2006;25(7):1101-13.
2006: Siu-Keung Tse; Jang-Yang Chang; Wei-Lun Su; Shein-Chung Chow; Chao Hsiung; Qingshu Lu
Statistical quality control process for traditional Chinese medicine.
Journal of biopharmaceutical statistics 2006;16(6):861-74.
2005: Jun Shao; Mark Chang; Shein-Chung Chow
Statistical inference for cancer trials with treatment switching.
Statistics in medicine 2005;24(12):1783-90.
2005: Hansheng Wang; Shein-Chung Chow; Murphy Chen
A Bayesian approach on sample size calculation for comparing means.
Journal of biopharmaceutical statistics 2005;15(5):799-807.
2005: Mark Chang; Shein-Chung Chow
A hybrid Bayesian adaptive design for dose response trials.
Journal of biopharmaceutical statistics 2005;15(4):677-91.
2005: Shein-Chung Chow; Jun Shao
Inference for clinical trials with some protocol amendments.
Journal of biopharmaceutical statistics 2005;15(4):659-66.
2005: Shein-Chung Chow; Mark Chang; Annpey Pong
Statistical consideration of adaptive methods in clinical development.
Journal of biopharmaceutical statistics 2005;15(4):575-91.
2004: Shein-Chung Chow; Jun Shao; Li Li
Assessing bioequivalence using genomic data.
Journal of biopharmaceutical statistics 2004;14(4):869-80.
2004: Li Li; Shein-Chung Chow; Woollcott Smith
Cross-validation for linear model with unequal variances in genomic analysis.
Journal of biopharmaceutical statistics 2004;14(3):723-39.
2004: Shein-Chung Chow; Jun Shao
Analysis of clinical data with breached blindness.
Statistics in medicine 2004;23(8):1185-93.
2003: Hansheng Wang; Bin Chen; Shein-Chung Chow
Sample size determination based on rank tests in clinical trials.
Journal of biopharmaceutical statistics 2003;13(4):735-51.
2003: Shein-Chung Chow; Jun Shao
Stability analysis with discrete responses.
Journal of biopharmaceutical statistics 2003;13(3):451-62.
2003: Christine E Swenson; Lois E Bolcsak; Gerald Batist; Troy H Guthrie; Katherine Tkaczuk; Harold Boxenbaum; Lauri Welles; Shein-Chung Chow; Rupinder Bhamra; Philip Chaikin
Pharmacokinetics of doxorubicin administered i.v. as Myocet (TLC D-99; liposome-encapsulated doxorubicin citrate) compared with conventional doxorubicin when given in combination with cyclophosphamide in patients with metastatic breast cancer.
Anti-cancer drugs 2003;14(3):239-46.
2003: Wenping Wang; Shein-Chung Chow
Examining outlying subjects and outlying records in bioequivalence trials.
Journal of biopharmaceutical statistics 2003;13(1):43-56.
2003: Shein-Chung Chow; Jun Shao; Hansheng Wang
In vitro bioequivalence testing.
Statistics in medicine 2003;22(1):55-68.
2002: Yonghee Lee; Jun Shao; Shein-Chung Chow; Hansheng Wang
Tests for inter-subject and total variabilities under crossover designs.
Journal of biopharmaceutical statistics 2002;12(4):503-34.
2002: Hansheng Wang; Shein-Chung Chow; Gang Li
On sample size calculation based on odds ratio in clinical trials.
Journal of biopharmaceutical statistics 2002;12(4):471-83.
2002: Shein-Chung Chow; Jun Shao; Hansheng Wang
A note on sample size calculation for mean comparisons based on noncentral t-statistics.
Journal of biopharmaceutical statistics 2002;12(4):441-56.
2002: Hansheng Wang; Shein-Chung Chow
A practical approach for comparing means of two groups without equal variance assumption.
Statistics in medicine 2002;21(20):3137-51.
2002: Shein-Chung Chow; Jun Shao
A note on statistical methods for assessing therapeutic equivalence.
Controlled clinical trials 2002;23(5):515-20.
2002: Shein-Chung Chow; Jun Shao; Oliver Yoa-Pu Hu
Assessing sensitivity and similarity in bridging studies.
Journal of biopharmaceutical statistics 2002;12(3):385-400.
2002: Jen-pei LIU; Shein-Chung Chow
Bridging studies in clinical development.
Journal of biopharmaceutical statistics 2002;12(3):359-67.
2002: Shein-Chung Chow; Jun Shao
On the assessment of similarity for dissolution profiles of two drug products.
Journal of biopharmaceutical statistics 2002;12(3):311-21.
2002: Hansheng Wan; Shein-Chung Chow
On statistical power for average bioequivalence testing under replicated crossover designs.
Journal of biopharmaceutical statistics 2002;12(3):295-309.
2002: Jun Shao; Shein-Chung Chow
Reproducibility probability in clinical trials.
Statistics in medicine 2002;21(12):1727-42.
2002: Shein-Chung Chow; Jun Shao; Hansheng Wang
Individual bioequivalence testing under 2x3 designs.
Statistics in medicine 2002;21(5):629-48.
2002: Shein-Chung Chow; Jun Shao; Hansheng Wang
Probability lower bounds for USP/NF tests.
Journal of biopharmaceutical statistics 2002;12(1):79-92.
2001: Jun Shao; Shein-Chung Chow
Two-phase shelf-life estimation.
Statistics in medicine 2001;20(8):1239-48.
2001: Shein-Chung Chow; H Wang
On sample size calculation in bioequivalence trials.
Journal of pharmacokinetics and pharmacodynamics 2001;28(2):155-69.
2000: Jun Shao; Shein-Chung Chow; B Wang
The bootstrap procedure in individual bioequivalence.
Statistics in medicine 2000;19(20):2741-54.
2000: Shein-Chung Chow; J Shao; H T Ho
On statistical analysis for placebo-challenging designs in clinical trials.
Statistics in medicine 2000;19(8):1029-37.
1997: J Liu; Shein-Chung Chow
A two one-sided tests procedure for assessment of individual bioequivalence.
Journal of biopharmaceutical statistics 1997;7(1):49-61.
1997: J Liu; Shein-Chung Chow
Some thoughts on individual bioequivalence.
Journal of biopharmaceutical statistics 1997;7(1):41-8.