Works about DRUG development

Results: 5000

Dynamic Information Borrowing From External Data in Clinical Trials: The Elastic Commensurate Prior Approach.

Published in:

Statistics in Medicine, 2025, v. 44, n. 13/14, p. 1, doi. 10.1002/sim.70129

By:

Huang, Jike;
Jia, Fan;
Li, Jiaxuan;
Xie, Wanqiu;
Rong, Zhiwei;
Mi, Lan;
Song, Yuqin;
Hou, Yan

Publication type:

Article

Recent Advances in Solid Lipid Nanoparticle Preparation: Methods, Ingredients, and Routes of Administration.

Published in:

Journal of Drug Delivery & Therapeutics, 2025, v. 15, n. 6, p. 175, doi. 10.22270/jddt.v15i6.7160

By:

Khisho, Chira Ibrahim;
Alfahad, Mohanad

Publication type:

Article

Simultaneous Method Development for Pseudoephedrine Hydrochloride and Desloratadine.

Published in:

Journal of Drug Delivery & Therapeutics, 2025, v. 15, n. 6, p. 6, doi. 10.22270/jddt.v15i6.7157

By:

Jain, Neha;
Kakde, Amol;
Kori, Mohan Lal

Publication type:

Article

Neurobiomarkers: Basic Aspects and Their Relevance in Nonclinical Studies.

Published in:

Toxicologic Pathology, 2025, v. 53, n. 4, p. 381, doi. 10.1177/01926233251335849

By:

Greiter-Wilke, Andrea;
Beckmann, Nicolau;
Glaab, Warren E.;
Theil, Diethilde J.;
Pardo, Ingrid D

Publication type:

Article

Methamphetamine and traumatic brain injury outcomes: an analysis of 29,416 patients from the national trauma data bank.

Published in:

Brain Injury, 2025, v. 39, n. 8, p. 646, doi. 10.1080/02699052.2025.2469705

By:

Sheets, Nicholas W.;
Shen, Yan;
Garland, Jeneva M.;
Plurad, David S.;
Harbour, Lori F.;
Orlando, Alessandro;
Fakhry, Samir M.

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

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

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

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

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

A community-led initiative to de-risk and advance Parkinson's disease therapeutic targets.

Published in:

NPJ Parkinson's Disease, 2025, v. 11, n. 1, p. 1, doi. 10.1038/s41531-025-01039-3

By:

Vaiana, Alexandra;
Behr, Jonathan;
Birol, Ryan;
Blauwendraat, Cornelis;
Casey, Bradford;
Chowdhury, Kushan;
Citron, Martin;
Crapser, Joshua;
Dardov, Victoria;
Ducotterd, Fiona;
Dumanis, Sonya;
Dunlop, John;
Durborow, Michelle;
Fiske, Brian;
Golden, Jessica;
Hannestad, Jonas;
Hung, Wendy;
Kemp, Jennifer;
Kleiman, Robin;
Knight, Adam

Publication type:

Article

Supplementary approaches to perinatal depression: a review of pathogenesis, herbal interventions, and dietary supplements.

Published in:

Frontiers in Psychology, 2025, p. 1, doi. 10.3389/fpsyg.2025.1529339

By:

Yang, Quancheng;
Lv, Yi;
Gao, Shenrong;
Zhang, Yu;
Zhai, Xuejia

Publication type:

Article

Insights from precision-cut lung slices—investigating mechanisms and therapeutics for pulmonary hypertension.

Published in:

Respiratory Research, 2025, v. 26, n. 1, p. 1, doi. 10.1186/s12931-025-03290-x

By:

Studley, William R.;
Lamanna, Emma;
Nold-Petry, Claudia A.;
Qin, Cheng Xue;
Bourke, Jane E.

Publication type:

Article

Multiscale modeling of drug-induced liver injury from organ to lobule.

Published in:

NPJ Digital Medicine, 2025, v. 8, n. 1, p. 1, doi. 10.1038/s41746-025-01736-6

By:

Malka-Markovitz, Alon;
Camara Dit Pinto, Stelian;
Cherkaoui, Mohammed;
Levine, Steven M.;
Anandasabapathy, Sharmila;
Sood, Gagan K.;
Dhingra, Sadhna;
Yujia, Gao;
Vierling, John M.;
Gallo, Nicolas R.

Publication type:

Article

Desulfurizative Fluorination of N‐CF3 Thioformamides for the Efficient Synthesis of N(CF3)(CF2H) Amines with Enhanced Stability.

Published in:

Angewandte Chemie, 2025, v. 137, n. 26, p. 1, doi. 10.1002/ange.202506154

By:

Wycich, Gina;
Ponce‐de‐León, Jaime;
Liu, Linhao;
Schoenebeck, Franziska

Publication type:

Article

Vimseltinib: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 985, doi. 10.1007/s40265-025-02191-z

By:

Lee, Arnold

Publication type:

Article

Mirdametinib: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 977, doi. 10.1007/s40265-025-02190-0

By:

Hoy, Sheridan M.

Publication type:

Article

Catumaxomab: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 957, doi. 10.1007/s40265-025-02187-9

By:

Syed, Yahiya Y.

Publication type:

Article

Datopotamab Deruxtecan: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 965, doi. 10.1007/s40265-025-02185-x

By:

Blair, Hannah A.

Publication type:

Article

ARTIFICIAL INTELLIGENCE IN DRUG DEVELOPMENT, CLINICAL TRIALS, AND HEALTHCARE.

Published in:

Acta Medica Medianae, 2025, v. 64, n. 1, p. 71, doi. 10.5633/amm.2025.0110

By:

Karalis, Vangelis;
Catić-Đorđević, Aleksandra

Publication type:

Article

Abstracts.

Published in:

2008

By:

Srivastava, S.

Publication type:

Abstract

Genomic approach to biomarker identification and its recent applications.

Published in:

Cancer Biomarkers, 2006, v. 2, n. 3/4, p. 103, doi. 10.3233/CBM-2006-23-404

By:

He, Yudong D.

Publication type:

Article

The process chain for peptidomic biomarker discovery.

Published in:

Cancer Biomarkers, 2005, v. 1, n. 4/5, p. 235

By:

Schrader, Michael;
Selle, Hartmut

Publication type:

Article

Evaluating Protocols for Assessing Toxicological Effects of Ethnopharmacological Agents on the Central Nervous System.

Published in:

Tropical Journal of Health Sciences, 2025, v. 32, n. 1, p. 31, doi. 10.4314/tjhc.v32i1.5

By:

Umukoro, E. K.;
Elijah, O. B.;
Moke, E. G.

Publication type:

Article

A Comprehensive Overview of US-FDA-Approved Anticancer Drugs and Biologics in 2023: An Observational Study.

Published in:

Journal of Pharmacy & Bioallied Sciences, 2025, v. 17, n. 1, p. 27, doi. 10.4103/jpbs.jpbs_730_25

By:

Shukla, Ajay Kumar;
Misra, Saurav

Publication type:

Article

Optimizing Chemotherapy Dose and Schedule by Norton-Simon Mathematical Modeling.

Published in:

Breast Disease, 2010, v. 31, n. 1, p. 7, doi. 10.3233/BD-2009-0290

By:

Traina, Tiffany A.;
Dugan, Ute;
Higgins, Brian;
Kolinsky, Kenneth;
Theodoulou, Maria;
Hudis, Clifford A.;
Norton, Larry

Publication type:

Article

Editorial: Striking the Right Balance for Eligibility Criteria for Clinical Trials in Inflammatory Bowel Disease.

Published in:

2025

By:

Solitano, Virginia;
Jairath, Vipul;
Danese, Silvio

Publication type:

Editorial

Two case reports of rare cocaine-associated dermatoses: Pyoderma gangrenosum and linear IgA bullous dermatosis.

Published in:

2025

By:

Cino, Daniela;
Marzario, Barbara;
Colantonio, Sophia;
Kirchhof, Mark G.

Publication type:

Case Study

Efficient synthesis and characterization of imidazo[1,2‐a]pyridine‐8‐carboxamide derivatives: A promising scaffold for drug development.

Published in:

Vietnam Journal of Chemistry, 2024, v. 62, n. 4, p. 556, doi. 10.1002/vjch.202300362

By:

Bhatt, Keval;
Patel, Dhara;
Rathod, Mrudangsinh;
Patel, Ashish;
Shah, Drashti

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

Application of estimand framework to the design and analysis of multi-regional clinical trials.

Published in:

Journal of Biopharmaceutical Statistics, 2025, v. 35, n. 4, p. 661, doi. 10.1080/10543406.2024.2362736

By:

Niu, Cuizhen;
Liang, Liwen;
Fu, Rong;
Zhong, Wenyan;
Wang, William W.B.

Publication type:

Article

An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment.

Published in:

Journal of Biopharmaceutical Statistics, 2025, v. 35, n. 4, p. 485, doi. 10.1080/10543406.2024.2341683

By:

Wu, Liwen;
Lin, Jianchang

Publication type:

Article

Statistical methods to control for confounders in rare disease settings that use external control.

Published in:

Journal of Biopharmaceutical Statistics, 2025, v. 35, n. 4, p. 531, doi. 10.1080/10543406.2024.2341650

By:

He, Jiwei;
Zhang, Di;
Li, Feng

Publication type:

Article

A Coalition to Advance Treatments for Parkinson's Disease, Dementia with Lewy Bodies, and Related Disorders.

Published in:

Journal of Parkinson's Disease, 2024, v. 14, n. 6, p. 1105, doi. 10.3233/JPD-230257

By:

Kopil, Catherine M.;
Asis, Angelica;
Campbell, Clyde;
Chowdhury, Sohini;
Dexter, David T.;
Fargo, Keith N.;
Lee, Karen K.;
Matthews, Helen;
Taylor, Angela;
Xiao, Yuge;
Stephenson, Diane

Publication type:

Article

This is NOT the End for Immunotherapy in Parkinson's Disease – A Perspective from Early Drug Development Scientists.

Published in:

Journal of Parkinson's Disease, 2022, v. 12, n. 8, p. 2293, doi. 10.3233/JPD-229008

By:

Brundin, Patrik;
Svoboda, Hanno;
Bonni, Azad;
Pagano, Gennaro

Publication type:

Article

Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2022 Update.

Published in:

Journal of Parkinson's Disease, 2022, v. 12, n. 4, p. 1073, doi. 10.3233/JPD-229002

By:

McFarthing, Kevin;
Rafaloff, Gary;
Baptista, Marco;
Mursaleen, Leah;
Fuest, Rosie;
Wyse, Richard K.;
Stott, Simon R.W.

Publication type:

Article

Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2021 Update.

Published in:

Journal of Parkinson's Disease, 2021, v. 11, n. 3, p. 891, doi. 10.3233/JPD-219006

By:

McFarthing, Kevin;
Rafaloff, Gary;
Baptista, Marco A.S.;
Wyse, Richard K.;
Stott, Simon R. W.

Publication type:

Article

Parkinson's Disease Drug Development Since 1999: A Story of Repurposing and Relative Success.

Published in:

Journal of Parkinson's Disease, 2021, v. 11, n. 2, p. 421, doi. 10.3233/JPD-202184

By:

Boucherie, Deirdre M.;
Duarte, Gonçalo S.;
Machado, Tiago;
Faustino, Patrícia R.;
Sampaio, Cristina;
Rascol, Olivier;
Ferreira, Joaquim J.

Publication type:

Article

Modeling Parkinson's Disease Using Patient-specific Induced Pluripotent Stem Cells.

Published in:

Journal of Parkinson's Disease, 2018, v. 8, n. 4, p. 479, doi. 10.3233/JPD-181353

By:

Li, Hong;
Jiang, Houbo;
Zhang, Boyang;
Feng, Jian

Publication type:

Article

Stomaching the Possibility of a Pathogenic Role for Helicobacter pylori in Parkinson’s Disease.

Published in:

Journal of Parkinson's Disease, 2018, v. 8, n. 3, p. 367, doi. 10.3233/JPD-181327

By:

McGee, David J.;
Lu, Xiao-Hong;
Disbrow, Elizabeth A.

Publication type:

Article

Rising to the Challenges of Clinical Trial Improvement in Parkinson's Disease.

Published in:

Journal of Parkinson's Disease, 2015, v. 5, n. 2, p. 263, doi. 10.3233/JPD-150541

By:

Mathur, Soania;
DeWitte, Steve;
Robledo, Israel;
Isaacs, Tom;
Stamford, Jon

Publication type:

Article

Drug discovery in the context of precision medicine and artificial intelligence.

Published in:

Expert Review of Precision Medicine & Drug Development, 2024, v. 9, n. 1, p. 42, doi. 10.1080/23808993.2024.2393089

By:

Hasanzad, Mandana;
Nosrati, Marzieh;
Khatami, Fatemeh;
Rahmani, Parham;
Sarhangi, Negar;
Nikfar, Shekoufeh;
Abdollahi, Mohammad

Publication type:

Article

Psoriasis inversa inducida por rituximab en un paciente con neuromielitis óptica.

Published in:

Dermatología Revista Mexicana, 2025, v. 69, n. 3, p. 403, doi. 10.24245/dermatolrevmex.v69i3.10522

By:

Pérez Vázquez, Gil;
García Rodríguez, Génesis Eglitza;
Rojas Caballero, Julia Stephanie;
Montes Hernández, Viridiana;
Díaz Molina, Valeria Lyzzete

Publication type:

Article

REACTION OF 6-AMINO-2-METHYLBENZOPYRIMIDIN- 4-ONE WITH ARYL SULFACHLORIDES.

Published in:

Austrian Journal of Technical & Natural Sciences, 2025, n. 3/4, p. 91, doi. 10.29013/AJT-25-3.4-91-94

By:

Abduxakimovich, Zulpanov Fazliddin;
Juraevich, Elmuradov Burkhon;
Oybek ugli, Kholikov Akbar;
Alijon kizi, Akhmedova Malika;
Xurramovich, Arzanov Ravshan

Publication type:

Article

Chemical compositions and pharmacological activities of Xanthium strumarium.

Published in:

Asian Journal of Traditional Medicines, 2024, v. 19, n. 6, p. 342

By:

Ruoming Li;
Yunpeng Yang;
Xiaomeng Zhang;
Yibo Wang;
Wenhan Wang;
Yao Zhao;
Yu Chen

Publication type:

Article