日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report

生理生物制药建模(PBBM)应用现状及新展望:研讨会报告

Tannergren, Christer; Arora, Sumit; Babiskin, Andrew; Borges, Luiza; Chatterjee, Parnali; Cheng, Yi-Hsien; Dallmann, André; Govada, Anitha; Heimbach, Tycho; Hingle, Martin; Kollipara, Sivacharan; Kotzagiorgis, Evangelos; Lindahl, Anders; Mackie, Claire; Malamatari, Maria; Mitra, Amitava; Moody, Rebecca; Pepin, Xavier; Polli, James; Raines, Kimberly; Rullo, Gregory; Sanghavi, Maitri; Savkur, Rajesh; Singh, Rajendra; Sjögren, Erik; Suarez-Sharp, Sandra; Thomas, Sherin; Veerasingham, Shereeni; Wei, Kevin; Wu, Fang; Xu, Yunming; Yoon, Miyoung; Rege, Bhagwant

Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions

基于生理学的生物制药模型开发报告模板:为满足监管申报要求而需考虑的质量改进问题

Arora, Sumit; Pepin, Xavier; Jamei, Masoud; Sharma, Pradeep; Heimbach, Tycho; Wagner, Christian; Bransford, Philip; Kollipara, Sivacharan; Ahmed, Tausif; Hingle, Martin; Dallmann, André; Scherholz, Megerle; Stamatis, Stephen D; Cano-Vega, Mario; Mistry, Nena; Tannergren, Christer; Borges, Luiza; Lindahl, Anders; Rullo, Gregory; Mackie, Claire; Mitra, Amitava; Kushner, Joseph; Harish Jain, Krutika Meena; Polli, James E

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

基于生理的生物药剂学建模(PBBM):药品质量、监管和行业展望的最佳实践:2023 年研讨会总结报告

Mackie, Claire; Arora, Sumit; Seo, Paul; Moody, Rebecca; Rege, Bhagwant; Pepin, Xavier; Heimbach, Tycho; Tannergren, Christer; Mitra, Amitava; Suarez-Sharp, Sandra; Borges, Luiza Novaes; Kijima, Shinichi; Kotzagiorgis, Evangelos; Malamatari, Maria; Veerasingham, Shereeni; Polli, James E; Rullo, Gregory

PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report

PBBM基础模型、模型验证和应用步骤的考量:研讨会总结报告

Heimbach, Tycho; Musuamba Tshinanu, Flora; Raines, Kimberly; Borges, Luiza; Kijima, Shinichi; Malamatari, Maria; Moody, Rebecca; Veerasingham, Shereeni; Seo, Paul; Turner, David; Fang, Lanyan; Stillhart, Cordula; Bransford, Philip; Ren, Xiaojun; Patel, Nikunjkumar; Sperry, David; Chen, Hansong; Rostami-Hodjegan, Amin; Lukacova, Viera; Sun, Duxin; Nguefack, Jean-Flaubert; Carducci, Tessa; Grimstein, Manuela; Pepin, Xavier; Jamei, Masoud; Stamatopoulos, Konstantinos; Li, Min; Sanghavi, Maitri; Tannergren, Christer; Mandula, Haritha; Zhao, Zhuojun; Ju, Tzuchi Rob; Wagner, Christian; Arora, Sumit; Wang, Michael; Rullo, Gregory; Mitra, Amitava; Kollipara, Sivacharan; Chirumamilla, Siri Kalyan; Polli, James E; Mackie, Claire

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

制定具有临床意义的口服药物溶出度规范——产业和监管视角

McAllister, Mark; Flanagan, Talia; Boon, Karin; Pepin, Xavier; Tistaert, Christophe; Jamei, Masoud; Abend, Andreas; Kotzagiorgis, Evangelos; Mackie, Claire

Preliminary investigation of 6,7-dihydropyrazolo[1,5-a]pyrazin-4-one derivatives as a novel series of mGlu5 receptor positive allosteric modulators with efficacy in preclinical models of schizophrenia

对6,7-二氢吡唑并[1,5-a]吡嗪-4-酮衍生物作为一类新型mGlu5受体正向变构调节剂的初步研究,该类化合物在精神分裂症的临床前模型中显示出疗效

Conde-Ceide, Susana; Alcázar, Jesús; Alonso de Diego, Sergio A; López, Silvia; Martín-Martín, María Luz; Martínez-Viturro, Carlos M; Pena, Miguel-Angel; Tong, Han Min; Lavreysen, Hilde; Mackie, Claire; Bridges, Thomas M; Daniels, J Scott; Niswender, Colleen M; Jones, Carrie K; Macdonald, Gregor J; Steckler, Thomas; Conn, P Jeffrey; Stauffer, Shaun R; Lindsley, Craig W; Bartolomé-Nebreda, José Manuel

Discovery and SAR of novel series of imidazopyrimidinones and dihydroimidazopyrimidinones as positive allosteric modulators of the metabotropic glutamate receptor 5 (mGlu5)

发现并研究新型咪唑并嘧啶酮和二氢咪唑并嘧啶酮类化合物作为代谢型谷氨酸受体5 (mGlu5) 正向变构调节剂的构效关系

Martín-Martín, María Luz; Bartolomé-Nebreda, José Manuel; Conde-Ceide, Susana; Alonso de Diego, Sergio A; López, Silvia; Martínez-Viturro, Carlos M; Tong, Han Min; Lavreysen, Hilde; Macdonald, Gregor J; Steckler, Thomas; Mackie, Claire; Bridges, Thomas M; Daniels, J Scott; Niswender, Colleen M; Noetzel, Meredith J; Jones, Carrie K; Conn, P Jeffrey; Lindsley, Craig W; Stauffer, Shaun R

Further optimization of the mGlu5 PAM clinical candidate VU0409551/JNJ-46778212: Progress and challenges towards a back-up compound

mGlu5 PAM 临床候选药物 VU0409551/JNJ-46778212 的进一步优化:备选化合物的进展与挑战

Zhou, Ya; Malosh, Chrysa; Conde-Ceide, Susana; Martínez-Viturro, Carlos Manuel; Alcázar, Jesus; Lavreysen, Hilde; Mackie, Claire; Bridges, Thomas M; Daniels, J Scott; Niswender, Colleen M; Jones, Carrie K; Macdonald, Gregor J; Steckler, Thomas; Conn, P Jeffrey; Stauffer, Shaun R; Bartolomé-Nebreda, José Manuel; Lindsley, Craig W

Acyl dihydropyrazolo[1,5-a]pyrimidinones as metabotropic glutamate receptor 5 positive allosteric modulators

酰基二氢吡唑并[1,5-a]嘧啶酮作为代谢型谷氨酸受体5正向变构调节剂

Malosh, Chrysa; Turlington, Mark; Bridges, Thomas M; Rook, Jerri M; Noetzel, Meredith J; Vinson, Paige N; Steckler, Thomas; Lavreysen, Hilde; Mackie, Claire; Bartolomé-Nebreda, José M; Conde-Ceide, Susana; Martínez-Viturro, Carlos M; Piedrafita, María; Sánchez-Casado, M Rosa; Macdonald, Gregor J; Daniels, J Scott; Jones, Carrie K; Niswender, Colleen M; Conn, P Jeffrey; Lindsley, Craig W; Stauffer, Shaun R

Tetrahydronaphthyridine and dihydronaphthyridinone ethers as positive allosteric modulators of the metabotropic glutamate receptor 5 (mGlu₠).

四氢萘啶和二氢萘啶酮醚作为代谢型谷氨酸受体 5 (mGluâ‚) 的正向变构调节剂

Turlington Mark, Malosh Chrysa, Jacobs Jon, Manka Jason T, Noetzel Meredith J, Vinson Paige N, Jadhav Satyawan, Herman Elizabeth J, Lavreysen Hilde, Mackie Claire, Bartolomé-Nebreda José M, Conde-Ceide Susana, Martín-Martín M Luz, Tong Han Min, López Silvia, MacDonald Gregor J, Steckler Thomas, Daniels J Scott, Weaver C David, Niswender Colleen M, Jones Carrie K, Conn P Jeffrey, Lindsley Craig W, Stauffer Shaun R