Works matching Drug development

Results: 5000

Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, p. S104, doi. 10.1002/jcph.1478

By:

Bi, Youwei;
Liu, Jiang;
Li, Lingjue;
Yu, Jingyu;
Bhattaram, Atul;
Bewernitz, Michael;
Li, Ruo‐jing;
Liu, Chao;
Earp, Justin;
Ma, Lian;
Zhuang, Luning;
Yang, Yuching;
Zhang, Xinyuan;
Zhu, Hao;
Wang, Yaning

Publication type:

Article

Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, p. S104, doi. 10.1002/jcph.1478

By:

Bi, Youwei;
Liu, Jiang;
Li, Lingjue;
Yu, Jingyu;
Bhattaram, Atul;
Bewernitz, Michael;
Li, Ruo‐jing;
Liu, Chao;
Earp, Justin;
Ma, Lian;
Zhuang, Luning;
Yang, Yuching;
Zhang, Xinyuan;
Zhu, Hao;
Wang, Yaning

Publication type:

Article

Implications of Pediatric Initiatives on CNS Drug Development for All Ages--2020 and Beyond: Second of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development.

Published in:

Innovations in Clinical Neuroscience, 2023, v. 20, n. 1-3, p. 18

By:

PANDINA, GAHAN;
BUSNER, JOAN;
HORRIGAN, JOSEPH P.;
MCSHERRY, CHRISTINE;
BATEMAN-HOUSE, ALISON;
PANI, LUCA;
KANDO, JUDITH

Publication type:

Article

Special Challenges in Pediatric Drug Development: First of Three Sets of Expanded Proceedings from the ISCTM Autumn Conference on Pediatric Drug Development.

Published in:

Innovations in Clinical Neuroscience, 2023, v. 20, n. 1-3, p. 13

By:

HARVEY, PHILIP D.;
BUSNER, JOAN;
PANDINA, GAHAN;
TAYLOR, H. GERRY;
GRABB, MEG;
JIMENEZ-SHAHED, JOOHI

Publication type:

Article

器官芯片与工程化人体组织在药物研发中的应用前景.

Published in:

Chinese Journal of Tissue Engineering Research / Zhongguo Zuzhi Gongcheng Yanjiu, 2020, v. 24, n. 29, p. 4717, doi. 10.3969/j.issn.2095-4344.2711

By:

陈沛杉;
张海燕

Publication type:

Article

Clinical pharmacology—how it shapes the drug development journey.

Published in:

European Journal of Clinical Pharmacology, 2025, v. 81, n. 4, p. 597, doi. 10.1007/s00228-025-03811-z

By:

Kruse, Matthias;
Stankeviciute, Simona;
Perry, Sheryl

Publication type:

Article

Introduction to the mini special issue on next generation drug discovery and development: rethinking translational pharmacology for accelerated drug development.

Published in:

Drug Metabolism Reviews, 2021, v. 53, n. 2, p. 171, doi. 10.1080/03602532.2021.1909614

By:

Nwabufo, Chukwunonso K.

Publication type:

Article

Collaboration in Development of New Drugs.

Published in:

Production & Operations Management, 2021, v. 30, n. 11, p. 3943, doi. 10.1111/poms.13377

By:

Tian, Zhili;
Gurnani, Haresh;
Xu, Yi

Publication type:

Article

Drug-induced QT interval prolongation: regulatory perspectives and drug development.

Published in:

Annals of Medicine, 2004, v. 36, p. 47, doi. 10.1080/17431380410032445

By:

Shah, Rashmi R

Publication type:

Article

Cancer drug development in Europe: a selection of new agents under development at the European Drug Development Network.

Published in:

2003

By:

Lacombe, D.;
Butler-Smith, A.;
Therasse, P.;
Fumoleau, P.;
Burtles, S.;
Calvert, H.;
Marsoni, S.;
Sessa, C.;
Verweij, J.

Publication type:

journal article

Model-Informed Drug Discovery and Development Strategy for the Rapid Development of Anti-Tuberculosis Drug Combinations.

Published in:

Applied Sciences (2076-3417), 2020, v. 10, n. 7, p. 2376, doi. 10.3390/app10072376

By:

van Wijk, Rob C.;
Ayoun Alsoud, Rami;
Lennernäs, Hans;
Simonsson, Ulrika S. H.

Publication type:

Article

Model-based clinical drug development in the past, present and future: a commentary.

Published in:

British Journal of Clinical Pharmacology, 2015, v. 79, n. 1, p. 108, doi. 10.1111/bcp.12341

By:

Kimko, Holly;
Pinheiro, José

Publication type:

Article

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.

Published in:

Pharmaceutical Research, 2022, v. 39, n. 8, p. 1669, doi. 10.1007/s11095-022-03288-w

By:

Madabushi, Rajanikanth;
Seo, Paul;
Zhao, Liang;
Tegenge, Million;
Zhu, Hao

Publication type:

Article

Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases: Third of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development.

Published in:

Innovations in Clinical Neuroscience, 2023, v. 20, n. 1-3, p. 25

By:

BUSNER, JOAN;
PANDINA, GAHAN;
DAY, SIMON;
MAHABLESHWARKAR, ATUL;
KEMPF, LUCAS;
SHEEAN, MARIA;
DUNN, JUDITH

Publication type:

Article

Patient-centered drug development and the Learning Health System.

Published in:

Learning Health Systems, 2017, v. 1, n. 3, p. n/a, doi. 10.1002/lrh2.10027

By:

Crawford, Laura S.;
Matczak, Gerald J.;
Moore, Erin M.;
Haydar, Rita A.;
Coderre, Pauline T.

Publication type:

Article

Advances in pharmacokinetic-pharmacodynamic modelling for pediatric drug development: extrapolations and exposure-response analyses.

Published in:

Expert Review of Clinical Pharmacology, 2023, v. 16, n. 12, p. 1201, doi. 10.1080/17512433.2023.2288171

By:

Goulooze, Sebastiaan C.;
Vis, Peter W.;
Krekels, Elke H.J.;
Knibbe, Catherijne A.J.

Publication type:

Article

Advances in drug development for targeted therapies for glioblastoma.

Published in:

Medicinal Research Reviews, 2020, v. 40, n. 5, p. 1950, doi. 10.1002/med.21676

By:

Yan, Ge;
Wang, Yunfu;
Chen, Jincao;
Zheng, Wenzhong;
Liu, Changzhen;
Chen, Shi;
Wang, Lianrong;
Luo, Jie;
Li, Zhiqiang

Publication type:

Article

Utility of physiologically based pharmacokinetic (PBPK) modeling in oncology drug development and its accuracy: a systematic review.

Published in:

European Journal of Clinical Pharmacology, 2018, v. 74, n. 11, p. 1365, doi. 10.1007/s00228-018-2513-6

By:

Saeheng, Teerachat;
Na-Bangchang, Kesara;
Karbwang, Juntra

Publication type:

Article

Modelling and simulation as research tools in paediatric drug development.

Published in:

European Journal of Clinical Pharmacology, 2011, v. 67, p. 75, doi. 10.1007/s00228-010-0974-3

By:

Bellanti, Francesco;
Della Pasqua, Oscar

Publication type:

Article

Regulatory scientific advice in drug development: does company size make a difference?

Published in:

European Journal of Clinical Pharmacology, 2011, v. 67, n. 2, p. 157, doi. 10.1007/s00228-010-0919-x

By:

Putzeist, Michelle;
Mantel-Teeuwisse, Aukje;
Gispen-De Wied, Christine;
Hoes, Arno;
Leufkens, Hubert

Publication type:

Article

An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results.

Published in:

European Journal of Clinical Pharmacology, 2009, v. 65, n. 3, p. 315, doi. 10.1007/s00228-008-0601-8

By:

Hole, Ola P.;
Nitter-Hauge, Sigurd;
Cederkvist, Henrik R.;
Winther, Finn Ø.

Publication type:

Article

Positron emission tomography microdosing: a new concept with application in tracer and early clinical drug development.

Published in:

European Journal of Clinical Pharmacology, 2003, v. 59, n. 5/6, p. 357, doi. 10.1007/s00228-003-0643-x

By:

Bergström, Mats;
Grahnén, Anders;
Långström, Bengt

Publication type:

Article

Aldehyde oxidase mediated drug metabolism: an underpredicted obstacle in drug discovery and development.

Published in:

Drug Metabolism Reviews, 2022, v. 54, n. 4, p. 427, doi. 10.1080/03602532.2022.2144879

By:

Gajula, Siva Nageswara Rao;
Nathani, Tanaaz Navin;
Patil, Rashmi Madhukar;
Talari, Sasikala;
Sonti, Rajesh

Publication type:

Article

Entering the era of computationally driven drug development.

Published in:

Drug Metabolism Reviews, 2020, v. 52, n. 2, p. 283, doi. 10.1080/03602532.2020.1726944

By:

Maharao, Neha;
Antontsev, Victor;
Wright, Matthew;
Varshney, Jyotika

Publication type:

Article

Ethical aspects in the use of artificial intelligence in the process of drug development.

Published in:

Brasov Medical Journal / Jurnal Medical Brasovean, 2023, n. 2, p. 53, doi. 10.31926/jmb.2023.2.8

By:

Pitel, Ecaterina;
Leașu, Florin;
Nicolau, Andrada;
Rogozea, Liliana

Publication type:

Article

Views of European Drug Development Stakeholders on Treatment Optimization and Its Potential for Use in Decision-Making.

Published in:

Frontiers in Pharmacology, 2020, p. 1, doi. 10.3389/fphar.2020.00043

By:

Saesen, Robbe;
Lejeune, Stéphane;
Quaglio, Gianluca;
Lacombe, Denis;
Huys, Isabelle

Publication type:

Article

Nematophilic bacteria associated with entomopathogenic nematodes and drug development of their biomolecules.

Published in:

Frontiers in Microbiology, 2022, v. 13, p. 1, doi. 10.3389/fmicb.2022.993688

By:

Awori, Ryan Musumba

Publication type:

Article

Invited review: Drug development for tauopathies.

Published in:

Neuropathology & Applied Neurobiology, 2015, v. 41, n. 1, p. 81, doi. 10.1111/nan.12192

By:

Grüninger, Fiona

Publication type:

Article

Development of Natural Compound Molecular Fingerprint (NC-MFP) with the Dictionary of Natural Products (DNP) for natural product-based drug development.

Published in:

Journal of Cheminformatics, 2020, v. 12, n. 1, p. 1, doi. 10.1186/s13321-020-0410-3

By:

Seo, Myungwon;
Shin, Hyun Kil;
Myung, Yoochan;
Hwang, Sungbo;
No, Kyoung Tai

Publication type:

Article

Application of Model‐Informed Drug Development in Dose Selection and Optimization for siRNA Therapies.

Published in:

Journal of Clinical Pharmacology, 2024, v. 64, n. 7, p. 799, doi. 10.1002/jcph.2418

By:

Yuan, Ye;
Li, Liang;
Earp, Justin;
Ma, Lian;
Bhattaram, Venkatesh Atul;
Sharma, Vishnu;
Tong, Alexander;
Wang, Yaning;
Liu, Jiang;
Zhu, Hao

Publication type:

Article

The Importance of Assessing Drug Pharmacokinetics and Pharmacodynamics in the Obese Population During Drug Development.

Published in:

Journal of Clinical Pharmacology, 2023, v. 63, p. S78, doi. 10.1002/jcph.2361

By:

Moore, Kenneth T.;
Zannikos, Peter N.;
Masters, Joanna C.;
Willmann, Stefan;
Shen, Jinshan;
Frost, Charles

Publication type:

Article

Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective.

Published in:

Journal of Clinical Pharmacology, 2023, v. 63, p. S65, doi. 10.1002/jcph.2349

By:

Pan, Xiaolei;
Wang, Li;
Liu, Jiang;
Earp, Justin C.;
Yang, Yuching;
Yu, Jingyu;
Li, Fang;
Bi, Youwei;
Bhattaram, Atul;
Zhu, Hao

Publication type:

Article

Obesity Considerations in Pediatric Drug Development, 2016–2021.

Published in:

Journal of Clinical Pharmacology, 2023, v. 63, p. S18, doi. 10.1002/jcph.2305

By:

Samuels, Sherbet;
Bhatt‐Mehta, Varsha;
Park, Kyunghun;
Burckart, Gilbert J.

Publication type:

Article

Regulatory Framework for Drug Development in Rare Diseases.

Published in:

Journal of Clinical Pharmacology, 2022, v. 62, p. S15, doi. 10.1002/jcph.2171

By:

Korth‐Bradley, Joan M.

Publication type:

Article

Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases.

Published in:

Journal of Clinical Pharmacology, 2022, v. 62, p. S27, doi. 10.1002/jcph.2143

By:

Li, Ruo‐Jing;
Ma, Lian;
Li, Fang;
Li, Liang;
Bi, Youwei;
Yuan, Ye;
Li, Yangbing;
Xu, Yuan;
Zhang, Xinyuan;
Liu, Jiang;
Bhattaram, Venkatesh Atul;
Wang, Jie;
Schuck, Robert;
Pacanowski, Michael;
Zhu, Hao

Publication type:

Article

Maternal–Fetal Drug Development: An Industry Perspective.

Published in:

Journal of Clinical Pharmacology, 2022, v. 62, p. S18, doi. 10.1002/jcph.2124

By:

Burnham, Janelle;
Darsey, Edress

Publication type:

Article

Physiologically Based Pharmacokinetic Modeling and Allometric Scaling in Pediatric Drug Development: Where Do We Draw the Line?

Published in:

Journal of Clinical Pharmacology, 2021, v. 61, p. S83, doi. 10.1002/jcph.1834

By:

Johnson, Trevor N.;
Ke, Alice B.

Publication type:

Article

Incorporating Ontogeny in Physiologically Based Pharmacokinetic Modeling to Improve Pediatric Drug Development: What We Know About Developmental Changes in Membrane Transporters.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, p. S56, doi. 10.1002/jcph.1489

By:

Cheung, Kit Wun Kathy;
Groen, Bianca D.;
Burckart, Gilbert J.;
Zhang, Lei;
Wildt, Saskia N.;
Huang, Shiew‐Mei

Publication type:

Article

Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, p. S87, doi. 10.1002/jcph.1482

By:

Conklin, Laurie S.;
Hoffman, Eric P.;
den Anker, John

Publication type:

Article

Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, n. 5, p. 625, doi. 10.1002/jcph.1359

By:

Shebley, Mohamad;
Menon, Rajeev M.;
Gibbs, John P.;
Dave, Nimita;
Marroum, Patrick J.;
Kim, Su Y.

Publication type:

Article

Incorporating Ontogeny in Physiologically Based Pharmacokinetic Modeling to Improve Pediatric Drug Development: What We Know About Developmental Changes in Membrane Transporters.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, p. S56, doi. 10.1002/jcph.1489

By:

Cheung, Kit Wun Kathy;
Groen, Bianca D.;
Burckart, Gilbert J.;
Zhang, Lei;
Wildt, Saskia N.;
Huang, Shiew‐Mei

Publication type:

Article

Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, p. S87, doi. 10.1002/jcph.1482

By:

Conklin, Laurie S.;
Hoffman, Eric P.;
den Anker, John

Publication type:

Article

FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".

Published in:

Journal of Clinical Pharmacology, 2018, v. 58, n. 12, p. 1655, doi. 10.1002/jcph.1285

By:

Akbar, Mohammad;
Berry‐Bibee, Erin;
Blithe, Diana L.;
Day, Ruth S.;
Edelman, Alison;
Höchel, Joachim;
Jamshidi, Roxanne;
Kim, Myong‐Jin;
Li, Li;
Purohit, Vivek S.;
Turpin, Jim A.;
Scott, Pamela E.;
Strauss, David G.;
Sun, Haiying;
Tepper, Naomi K.;
Zhang, Lei;
Yu, Chongwoo

Publication type:

Article

Estimating the clinical cost of drug development for orphan versus non-orphan drugs.

Published in:

2019

By:

Jayasundara, Kavisha;
Hollis, Aidan;
Krahn, Murray;
Mamdani, Muhammad;
Hoch, Jeffrey S.;
Grootendorst, Paul

Publication type:

journal article

Rare disease registries: potential applications towards impact on development of new drug treatments.

Published in:

2018

By:

Jansen-van der Weide, Marijke C.;
Gaasterland, Charlotte M. W.;
Roes, Kit C. B.;
Pontes, Caridad;
Vives, Roser;
Sancho, Arantxa;
Nikolakopoulos, Stavros;
Vermeulen, Eric;
van der Lee, Johanna H.

Publication type:

journal article

One small step in time, one giant leap for DMPK kind – a CRO perspective of the evolving core discipline of drug development.

Published in:

Xenobiotica, 2022, v. 52, n. 8, p. 797, doi. 10.1080/00498254.2022.2124389

By:

Kendrick, John S.;
Webber, Colin

Publication type:

Article

Is there a role of synovial biopsy in drug development?

Published in:

2016

By:

Filkova, Maria;
Cope, Andrew;
Mant, Tim;
Galloway, James

Publication type:

journal article

Optimal designs for phase II/III drug development programs including methods for discounting of phase II results.

Published in:

2020

By:

Erdmann, Stella;
Kirchner, Marietta;
Götte, Heiko;
Kieser, Meinhard

Publication type:

journal article

New frontiers in immune checkpoint B7-H3 (CD276) research and drug development.

Published in:

2023

By:

Getu, Ayechew Adera;
Tigabu, Abiye;
Zhou, Ming;
Lu, Jianrong;
Fodstad, Øystein;
Tan, Ming

Publication type:

Literature Review

Genetically engineered mice in drug development.

Published in:

1999

By:

Livingston, J. N.

Publication type:

journal article