Works matching IS 07248741 AND DT 2025 AND VI 42 AND IP 5

Results: 14

Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 731, doi. 10.1007/s11095-025-03861-z

By:

Fang, Lanyan;
Tsakalozou, Eleftheria;
Wu, Fang;
Ritterbeck, Daniel;
Zhao, Liang;
Zhang, Lei;
Lionberger, Robert

Publication type:

Article

Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 819, doi. 10.1007/s11095-025-03849-9

By:

Cheng, Yi-Hsien;
Thomas, Sherin;
Tsang, Yu Chung;
Almeida, Susana;
Ashraf, Muhammad;
Fotaki, Nikoletta;
Heimbach, Tycho;
Patel, Nikunjkumar;
Shah, Harshil;
Jiang, Xiaojian;
Kim, Myong-Jin;
Moody, Rebecca;
Rostami‐Hodjegan, Amin;
Singh, Romi;
Zhao, Liang;
Babiskin, Andrew;
Wu, Fang

Publication type:

Article

Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 727, doi. 10.1007/s11095-025-03868-6

By:

Fang, Lanyan;
Tsakalozou, Eleftheria;
Polli, James E.

Publication type:

Article

Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 835, doi. 10.1007/s11095-025-03866-8

By:

Pal, Arindom;
Alam, Khondoker;
Stier, Ethan;
Heimbach, Tycho;
Cristofoletti, Rodrigo;
Al‐Gousous, Jozef;
Langguth, Peter;
Žakelj, Rebeka;
Ahmed, Tausif;
Almeida, Susana;
Fan, Jianghong;
Kolhatkar, Vidula;
Paixão, Paulo;
Rayeni, Mohan Krishna;
Zhang, Lei;
Wu, Fang

Publication type:

Article

Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 753, doi. 10.1007/s11095-025-03865-9

By:

Cheng, Yi-Hsien;
Pal, Arindom;
Moody, Rebecca;
Heimbach, Tycho;
Lukacova, Viera;
Patel, Nikunjkumar;
Rullo, Gregory;
Xu, Yunming;
Ahmed, Tausif;
Kerwash, Essam;
Fang, Lanyan;
Wu, Fang

Publication type:

Article

PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 847, doi. 10.1007/s11095-025-03846-y

By:

Wu, Fang;
Tsakalozou, Eleftheria;
Burckart, Gilbert J.;
Žakelj, Rebeka;
Gaohua, Lu;
Sagawa, Kazuko;
Lukacova, Viera;
Vaithiyalingam, Siva;
Fan, Jianghong;
Fotaki, Nikoletta;
Patel, Nikunjkumar;
Fang, Lanyan

Publication type:

Article

Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 785, doi. 10.1007/s11095-025-03844-0

By:

Kollipara, Sivacharan;
Friden, Markus;
Heimbach, Tycho;
Saha, Pratik;
De Backer, Jan;
Ahmed, Tausif;
Nicholas, Timothy

Publication type:

Article

Immunogenicity of Generic Peptide Impurities: Current Orthogonal Approaches.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 805, doi. 10.1007/s11095-025-03843-1

By:

De Groot, Anne S.;
Mattei, Aimee;
Gabriel, Benjamin;
Calderini, Jennifer;
Roberts, Brian J.;
Lelias, Sandra;
McAllister, Mitchell;
Boyle, Christine;
Martin, William;
Richard, Guilhem

Publication type:

Article

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

Leveraging Model Master Files from a Technology Company Perspective: Facilitating Quantitative Medicine in Regulatory Frameworks.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 795, doi. 10.1007/s11095-025-03833-3

By:

De Backer, Jan;
Clarke, James;
Sadafi, Hosein;
Ganley, William;
Spires, Jessica

Publication type:

Article

Correction: Leveraging Model Master Files for Long-Acting Injectables.

Published in:

2025

By:

Gong, Yuqing;
Hopefl, Robert;
Li, Tonglei;
Hooker, Andrew C.;
Silva, Daniela Amaral;
Alam, Khondoker;
Ducharme, Murray;
Moody, Rebecca;
Saha, Pratik;
Babiskin, Andrew

Publication type:

Correction Notice

Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 765, doi. 10.1007/s11095-025-03831-5

By:

Liu, Jiang;
Yang, Yuching;
Gobburu, Joga;
Musante, Cynthia J.;
Klein, Martin;
Zhao, Liang;
Madabushi, Rajanikanth;
Zhu, Hao

Publication type:

Article

Leveraging Model Master Files for Long-Acting Injectables.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 747, doi. 10.1007/s11095-025-03824-4

By:

Gong, Yuqing;
Hopefl, Robert;
Li, Tonglei;
Hooker, Andrew C.;
Silva, Daniela Amaral;
Alam, Khondoker;
Ducharme, Murray;
Moody, Rebecca;
Saha, Pratik;
Babiskin, Andrew

Publication type:

Article

Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products.

Published in:

Pharmaceutical Research, 2025, v. 42, n. 5, p. 773, doi. 10.1007/s11095-025-03823-5

By:

Walenga, Ross L.;
Alam, Khondoker;
Clarke, James F.;
De Backer, Jan;
Fridén, Markus;
Hamadeh, Abdullah;
Mowli, Jay;
Sonti, Sujatha;
Spires, Jessica;
Tan, Ming-Liang;
Musuamba, Flora T.;
Tsakalozou, Eleftheria

Publication type:

Article