Works by Grosser, Stella

Results: 29

Considering Opportunities and Challenges When Implementing the Model Master File Framework – a Meeting Report.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 737, doi. 10.1007/s11095-025-03839-x

By:

Tsakalozou, Eleftheria;
Fang, Lanyan;
Skoda, Erin;
Nicholas, Timothy;
Kollipara, Sivacharan;
Ren, Ke;
Grosser, Stella;
Rege, Bhagwant;
Roy, Partha;
Zhu, Hao;
Zhao, Liang

Publication type:

Article

Clustering plasma concentration-time curves: applications of unsupervised learning in pharmacogenomics.

Published in:

Journal of Biopharmaceutical Statistics, 2025, v. 35, n. 4, p. 678, doi. 10.1080/10543406.2024.2365389

By:

Lautier, Jackson P.;
Grosser, Stella;
Kim, Jessica;
Kim, Hyewon;
Kim, Junghi

Publication type:

Article

Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies.

Published in:

CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 7, p. 904, doi. 10.1002/psp4.12960

By:

Tardivon, Coralie;
Loingeville, Florence;
Donnelly, Mark;
Feng, Kairui;
Sun, Wanjie;
Sun, Guoying;
Grosser, Stella;
Zhao, Liang;
Fang, Lanyan;
Mentré, France;
Bertrand, Julie

Publication type:

Article

Likelihood techniques for interlaboratory calibration in the national stream survey.

Published in:

Journal of Chemometrics, 1991, v. 5, n. 3, p. 299, doi. 10.1002/cem.1180050316

By:

Permutt, Thomas;
Edland, Steven D.;
Moezzi, Mithra;
Grosser, Stella C.

Publication type:

Article

PERSONAL AND ENVIRONMENTAL CHARACTERISTICS RELATED TO EPITHELIAL OVARIAN CANCER.

Published in:

American Journal of Epidemiology, 1988, v. 128, n. 6, p. 1228, doi. 10.1093/oxfordjournals.aje.a115077

By:

WHITTEMORE, ALICE S.;
WU, MARION L.;
PAFFENBARGER, RALPH S.;
SARLES, DORIEN L.;
KAMPERT, JAMES B.;
GROSSER, STELLA;
JUNG, DEXTER L.;
BALLON, SAMUEL;
HENDRICKSON, MICHAEL

Publication type:

Article

PERSONAL AND ENVIRONMENTAL CHARACTERISTICS RELATED TO EPITHELIAL OVARIAN CANCER.

Published in:

American Journal of Epidemiology, 1988, v. 128, n. 6, p. 1216, doi. 10.1093/oxfordjournals.aje.a115076

By:

WU, MARION L.;
WHITTEMORE, ALICE S.;
PAFFENBARGER, RALPH S.;
SARLES, DORIEN L.;
KAMPERT, JAMES B.;
GROSSER, STELLA;
JUNG, DEXTER L.;
BALLON, SAMUEL;
HENDRICKSON, MICHAEL;
MOHLE-BOETANI, JANET

Publication type:

Article

Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2022, v. 49, n. 5, p. 557, doi. 10.1007/s10928-022-09821-z

By:

Guhl, Mélanie;
Mercier, François;
Hofmann, Carsten;
Sharan, Satish;
Donnelly, Mark;
Feng, Kairui;
Sun, Wanjie;
Sun, Guoying;
Grosser, Stella;
Zhao, Liang;
Fang, Lanyan;
Mentré, France;
Comets, Emmanuelle;
Bertrand, Julie

Publication type:

Article

Efficient model-based bioequivalence testing.

Published in:

2022

By:

Möllenhoff, Kathrin;
Loingeville, Florence;
Bertrand, Julie;
Nguyen, Thu Thuy;
Sharan, Satish;
Zhao, Liang;
Fang, Lanyan;
Sun, Guoying;
Grosser, Stella;
Mentré, France;
Dette, Holger

Publication type:

journal article

Comparison of AIDS Progression and Survival in Persons with Pulmonary versus Extrapulmonary Tuberculosis in Los Angeles.

Published in:

AIDS Patient Care & STDs, 2001, v. 15, n. 9, p. 463, doi. 10.1089/108729101753145457

By:

Wohl, Amy Rock;
Lu, Sharon;
Rollins, Jane N.;
Simon, Paul A.;
Grosser, Stella;
Kerndt, Peter R.

Publication type:

Article

Statistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs.

Published in:

Journal of Biopharmaceutical Statistics, 2019, v. 29, n. 5, p. 952, doi. 10.1080/10543406.2019.1657440

By:

Sun, Wanjie;
Grosser, Stella;
Kim, Carol;
Raney, Sam G.

Publication type:

Article

Ratio of means vs. difference of means as measures of superiority, noninferiority, and average bioequivalence.

Published in:

Journal of Biopharmaceutical Statistics, 2017, v. 27, n. 2, p. 338, doi. 10.1080/10543406.2016.1265536

By:

Sun, Wanjie;
Grosser, Stella;
Tsong, Yi

Publication type:

Article

Adaptive designs for IVPT data with mixed scaled average bioequivalence.

Published in:

Pharmaceutical Statistics, 2023, v. 22, n. 6, p. 1116, doi. 10.1002/pst.2333

By:

Lim, Daeyoung;
Rantou, Elena;
Kim, Jessica;
Choi, Sungwoo;
Choi, Nam Hee;
Grosser, Stella

Publication type:

Article

Comments on "Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study".

Published in:

Pharmaceutical Statistics, 2022, v. 21, n. 6, p. 1366, doi. 10.1002/pst.2255

By:

Sun, Wanjie;
Schuirmann, Donald J.;
Grosser, Stella

Publication type:

Article

Validity of Self-Reporting of Episodes of External Genital Warts.

Published in:

Clinical Infectious Diseases, 2002, v. 35, n. 1, p. 39

By:

Wiley, D. J.;
Grosser, Stella;
Qi, Karen;
Visscher, Barbara R.;
Beutner, Karl;
Strathdee, Steffanie A.;
Calhoun, Bridget;
Palella, Frank;
Detels, Roger

Publication type:

Article

On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence.

Published in:

Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 2, p. 304, doi. 10.1002/cpt.1291

By:

Schuirmann, Donald J.;
Grosser, Stella;
Chattopadhyay, Somesh;
Chow, Shein‐Chung

Publication type:

Article

Letter to the Editor on “Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies”.

Published in:

2024

By:

Sun, Wanjie;
Alosh, Mohamed;
Schuirmann, Donald J.;
Grosser, Stella

Publication type:

Letter

The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.

Published in:

AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00897-8

By:

Fang, Lanyan;
Gong, Yuqing;
Hooker, Andrew C.;
Lukacova, Viera;
Rostami-Hodjegan, Amin;
Sale, Mark;
Grosser, Stella;
Jereb, Rebeka;
Savic, Rada;
Peck, Carl;
Zhao, Liang

Publication type:

Article

Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00715-z

By:

Sharan, Satish;
Choi, Sungwoo;
Zou, Yuan;
Wang, Yan;
Kim, Myong-Jin;
Fang, Lanyan;
Choi, Stephanie;
Makhlouf, Fairouz;
Grosser, Stella C.;
Zhang, Xinyuan;
Zhao, Liang

Publication type:

Article

New Model–Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00507-3

By:

Loingeville, Florence;
Bertrand, Julie;
Nguyen, Thu Thuy;
Sharan, Satish;
Feng, Kairui;
Sun, Wanjie;
Han, Jing;
Grosser, Stella;
Zhao, Liang;
Fang, Lanyan;
Möllenhoff, Kathrin;
Dette, Holger;
Mentré, France

Publication type:

Article

Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.

Published in:

PLoS ONE, 2023, v. 18, n. 10, p. 1, doi. 10.1371/journal.pone.0292231

By:

Herndon, Thomas M.;
Ausin, Cristina;
Brahme, Nina N.;
Schrieber, Sarah J.;
Luo, Michelle;
Andrada, Frances C.;
Kim, Carol;
Sun, Wanjie;
Zhou, Lingjie;
Grosser, Stella;
Yim, Sarah;
Ricci, M. Stacey

Publication type:

Article

Qualitative versus Quantitative Treatment-by-Subgroup Interaction in Equivalence Studies with Multiple Subgroups.

Published in:

Statistics in Biopharmaceutical Research, 2023, v. 15, n. 4, p. 737, doi. 10.1080/19466315.2022.2123385

By:

Wanjie Sun;
Schuirmann, Don;
Grosser, Stella

Publication type:

Article

Statement on P-values.

Published in:

2021

By:

Gwise, Thomas;
Rothmann, Mark D.;
James Hung, H.M.;
Amatya, Anup;
Rothwell, Rebecca;
Wang, Sue Jane;
Wu, Yute;
Smith, Fraser;
Weng, Yu-Ting;
Andraca-Carrera, Eugenio;
Grosser, Stella;
Chattopadhyay, Somesh;
Collins, Sylva H.

Publication type:

Letter

A Meta-Analysis of Missing Data and Non-Compliance Data in Clinical Endpoint Bioequivalence Studies.

Published in:

Statistics in Biopharmaceutical Research, 2016, v. 8, n. 3, p. 334, doi. 10.1080/19466315.2016.1201000

By:

Sun, Wanjie;
Zhou, Lingjie;
Grosser, Stella;
Kim, Carol

Publication type:

Article

Determining Equivalence for Generic Locally Acting Drug Products.

Published in:

Statistics in Biopharmaceutical Research, 2015, v. 7, n. 4, p. 337, doi. 10.1080/19466315.2015.1093541

By:

Grosser, Stella;
Park, Misook;
Raney, Sam G.;
Rantou, Elena

Publication type:

Article

Increased Immune Activation Precedes the Inflection Point of CD4 T Cells and the Increased Serum Virus Load in Human Immunodeficiency Virus Infection.

Published in:

Journal of Infectious Diseases, 1998, v. 178, n. 2, p. 423, doi. 10.1086/515629

By:

Salazar-Gonzalez, Jesus F.;
Martinez-Maza, Otoniel;
Nishanian, Parunag;
Aziz, Najib;
Shen, Lu-Ping;
Grosser, Stella;
Taylor, Jeremy;
Detels, Roger;
Fahey, John L.

Publication type:

Article

Postpartum and nonpostpartum depression: differences in presentation and response to pharmacologic treatment.

Published in:

2000

By:

Hendrick, Victoria;
Altshuler, Lori;
Strouse, Tom;
Grosser, Stella;
Hendrick, V;
Altshuler, L;
Strouse, T;
Grosser, S

Publication type:

journal article

Statistical considerations in the design, analysis and interpretation of clinical studies that use patient-reported outcomes.

Published in:

2014

By:

Kammerman, Lisa A;
Grosser, Stella

Publication type:

Journal Article

Statistical considerations in the design, analysis and interpretation of clinical studies that use patient-reported outcomes*.

Published in:

Statistical Methods in Medical Research, 2014, v. 23, n. 5, p. 393, doi. 10.1177/0962280213498013

By:

Kammerman, Lisa A;
Grosser, Stella

Publication type:

Article

Model‐based bioequivalence approach for sparse pharmacokinetic bioequivalence studies: Model selection or model averaging?

Published in:

Statistics in Medicine, 2024, v. 43, n. 18, p. 3403, doi. 10.1002/sim.10088

By:

Philipp, Morgane;
Tessier, Adrien;
Donnelly, Mark;
Fang, Lanyan;
Feng, Kairui;
Zhao, Liang;
Grosser, Stella;
Sun, Guoying;
Sun, Wanjie;
Mentré, France;
Bertrand, Julie

Publication type:

Article