Search Results - "Drug development"

Improvements in Data Quality Can Boost Efficiency and Reduce Development Costs: A Pharmacometric CRO's Perspective.

Authors: de la Peña A Fiedler-Kelly J Humphrey RL et al.

Source: The AAPS journal [AAPS J] 2025 Dec 05; Vol. 28 (1), pp. 28. Date of Electronic Publication: 2025 Dec 05.

Publication Type: Journal Article

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

MeSH Terms: Drug Development*/economics , Drug Development*/methods , Drug Development*/standards , Data Accuracy* , Drug Industry*/economics, Humans ; Surveys and Questionnaires

Recent Utilization of Pediatric Extrapolation and Modeling and Simulation Approaches in Pediatric Drug Development in Japan.

Authors: Nakashima A Tsujimoto A Saito M et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Dec; Vol. 65 (12), pp. 1889-1899. Date of Electronic Publication: 2025 Aug 17.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

MeSH Terms: Drug Development*/methods , Models, Biological*, Humans ; Japan ; Child ; Drug Approval ; Computer Simulation ; Pediatrics

Developing New Drugs for the COVID-19 Emergency: Anatomy of the U.S. Response.

Authors: Moore TJ Socal MP Anderson G

Source: Pharmacotherapy [Pharmacotherapy] 2025 Nov; Vol. 45 (11), pp. 780-790. Date of Electronic Publication: 2025 Oct 22.

Publication Type: Journal Article; Review

Journal Info: Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 8111305 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1875-9114 (Electronic) Linking ISSN: 02770008 NLM ISO Abbreviation: Pharmacotherapy Subsets: MEDLINE

MeSH Terms: COVID-19 Drug Treatment* , Antiviral Agents*/therapeutic use , Antiviral Agents*/economics , Drug Development*/organization & administration , Drug Development*/methods , Drugs, Investigational*/therapeutic use, Humans ; United States ; Drug Approval ; United States Food and Drug Administration ; COVID-19 ; SARS-CoV-2/drug effects

Use of Biomarkers in Drug Development for Regulatory Purposes.

Authors: Schuck RN Sekar V

Source: Clinical and translational science [Clin Transl Sci] 2025 Oct; Vol. 18 (10), pp. e70377.

Publication Type: Journal Article

Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

MeSH Terms: Biomarkers*/analysis , Drug Approval*/legislation & jurisprudence , Drug Development*/legislation & jurisprudence , Drug Development*/methods, Humans ; Reproducibility of Results ; United States ; United States Food and Drug Administration

A Case Study of Model-Informed Drug Development of a Novel PCSK9 Antisense Oligonucleotide. Part 2: Phase 2 to Phase 3.

Authors: Knöchel J Nilsson C Carlsson B et al.

Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2025 Oct; Vol. 14 (10), pp. 1556-1561. Date of Electronic Publication: 2025 Aug 05.

Publication Type: Case Reports; Journal Article

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE

MeSH Terms: Oligonucleotides, Antisense*/administration & dosage , Oligonucleotides, Antisense*/pharmacology , Proprotein Convertase 9*/genetics , Drug Development*/methods , PCSK9 Inhibitors*, Humans ; Cholesterol, LDL/blood ; Computer Simulation ; Models, Biological ; Clinical Trials, Phase III as Topic

Paediatric Strategy Forum for medicinal product development of agents targeting GD2 ganglioside in children and adolescents with cancer.

Authors: DuBois SG Moreno L Bagatell R et al.

Source: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2025 Dec 09; Vol. 231, pp. 116093. Date of Electronic Publication: 2025 Nov 05.

Publication Type: Journal Article; Review

Journal Info: Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE

MeSH Terms: Gangliosides*/antagonists & inhibitors , Gangliosides*/immunology , Gangliosides*/metabolism , Neoplasms*/drug therapy , Neoplasms*/immunology , Neoplasms*/metabolism , Drug Development* , Antineoplastic Agents, Immunological*/therapeutic use , Antineoplastic Agents*/therapeutic use, Humans ; Child ; Adolescent ; Neuroblastoma/drug therapy ; Neuroblastoma/immunology ; Immunoconjugates/therapeutic use ; Antibodies, Monoclonal/therapeutic use

Can the Development of Orphan Drugs Include Wider Patient Engagement? A Citizens' Jury to Explore a Promissory Notion.

Authors: Frost J Mandizha J van den Dungen C et al.

Corporate Authors: Frost J Mandizha J van den Dungen C et al.

Source: Health expectations : an international journal of public participation in health care and health policy [Health Expect] 2025 Dec; Vol. 28 (6), pp. e70524.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 9815926 Publication Model: Print Cited Medium: Internet ISSN: 1369-7625 (Electronic) Linking ISSN: 13696513 NLM ISO Abbreviation: Health Expect Subsets: MEDLINE

MeSH Terms: Patient Participation*/methods , Orphan Drug Production* , Rare Diseases*/drug therapy , Drug Development*, Humans ; Clinical Trials as Topic ; Anthropology, Cultural ; Community Participation

How AI Transforms Regulatory Submission: Current Clinical Implementation and Future Prospects.

Authors: Podichetty JT Bauer AM Xu R et al.

Source: Clinical and translational science [Clin Transl Sci] 2025 Dec; Vol. 18 (12), pp. e70434.

Publication Type: Journal Article

Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

MeSH Terms: Artificial Intelligence*/trends , Drug Development*/methods , Drug Development*/legislation & jurisprudence , Drug Approval*, Humans ; United States Food and Drug Administration ; United States

AAV Gene Therapy Drug Development and Translation of Engineered Ocular and Neurotropic Capsids: A Systematic Review Using Natural Language Processing.

Authors: Agbim C Wu HY Kim C et al.

Source: Clinical and translational science [Clin Transl Sci] 2025 Dec; Vol. 18 (12), pp. e70428.

Publication Type: Journal Article; Systematic Review; Review

Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

MeSH Terms: Dependovirus*/genetics , Capsid* , Genetic Vectors*/administration & dosage , Genetic Vectors*/genetics , Genetic Therapy*/methods , Drug Development*/methods, Humans ; Animals ; Natural Language Processing ; Translational Research, Biomedical ; Gene Therapy Agents

A review on pyrimidine-based pharmacophore as a template for the development of hybrid drugs with anticancer potential.

Authors: Sharma S Babu MA Kumar R et al.

Source: Molecular diversity [Mol Divers] 2025 Dec; Vol. 29 (6), pp. 5283-5305. Date of Electronic Publication: 2025 Feb 12.

Publication Type: Journal Article; Review

Journal Info: Publisher: ESCOM Science Publishers Country of Publication: Netherlands NLM ID: 9516534 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-501X (Electronic) Linking ISSN: 13811991 NLM ISO Abbreviation: Mol Divers Subsets: MEDLINE

MeSH Terms: Antineoplastic Agents*/chemistry , Antineoplastic Agents*/pharmacology , Antineoplastic Agents*/therapeutic use , Pyrimidines*/chemistry , Pyrimidines*/pharmacology , Pyrimidines*/therapeutic use , Drug Development* , Neoplasms*/drug therapy, Humans ; Drug Discovery/methods ; Animals ; Drug Design ; Pharmacophore

Investigation of bone toxicity in drug development: review of current and emerging technologies.

Authors: Tuladhar A Guffroy M Finnema SJ et al.

Source: Toxicological sciences : an official journal of the Society of Toxicology [Toxicol Sci] 2025 Dec 01; Vol. 208 (2), pp. 207-224.

Publication Type: Journal Article; Review

Journal Info: Publisher: Oxford University Press Country of Publication: United States NLM ID: 9805461 Publication Model: Print Cited Medium: Internet ISSN: 1096-0929 (Electronic) Linking ISSN: 10960929 NLM ISO Abbreviation: Toxicol Sci Subsets: MEDLINE

MeSH Terms: Bone and Bones*/drug effects , Bone and Bones*/pathology , Bone and Bones*/metabolism , Drug Development*/methods , Toxicity Tests*/methods, Animals ; Humans ; Bone Remodeling/drug effects

Bromodomain containing protein 4 (BRD4) and cancer therapy: A glimpse at dual-target drug development.

Authors: Li Z Wang H Liu B et al.

Source: Biochemical pharmacology [Biochem Pharmacol] 2025 Dec; Vol. 242 (Pt 4), pp. 117418. Date of Electronic Publication: 2025 Oct 11.

Publication Type: Journal Article; Review

Journal Info: Publisher: Elsevier Science Country of Publication: England NLM ID: 0101032 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2968 (Electronic) Linking ISSN: 00062952 NLM ISO Abbreviation: Biochem Pharmacol Subsets: MEDLINE

MeSH Terms: Cell Cycle Proteins*/metabolism , Cell Cycle Proteins*/antagonists & inhibitors , Neoplasms*/drug therapy , Neoplasms*/metabolism , Neoplasms*/genetics , Transcription Factors*/metabolism , Transcription Factors*/antagonists & inhibitors , Transcription Factors*/genetics , Antineoplastic Agents*/administration & dosage , Antineoplastic Agents*/pharmacology , Drug Development*/methods , Drug Delivery Systems*/methods , Drug Delivery Systems*/trends, Humans ; Animals ; Bromodomain Containing Proteins

A Fast Path from Innovation to Safe and Effective Medicines.

Authors: Arlett P Ehmann F Herold R et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2025 Dec; Vol. 118 (6), pp. 1392-1404. Date of Electronic Publication: 2025 Oct 28.

Publication Type: Journal Article; Review

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

MeSH Terms: Drug Development*/methods , Drug Development*/legislation & jurisprudence, Humans ; Drug Industry ; Drug Approval

Making modafinil: Classification and serendipity in drug development.

Authors: Scholte SJ Yaqub O

Source: Social studies of science [Soc Stud Sci] 2025 Dec; Vol. 55 (6), pp. 842-861. Date of Electronic Publication: 2025 Mar 18.

Publication Type: Journal Article; Historical Article

Journal Info: Publisher: Sage Publications Country of Publication: United States NLM ID: 7506743 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1460-3659 (Electronic) Linking ISSN: 03063127 NLM ISO Abbreviation: Soc Stud Sci Subsets: MEDLINE

MeSH Terms: Modafinil*/history , Modafinil*/classification , Drug Development*/history, Humans ; History, 20th Century ; Orphan Drug Production/history ; History, 21st Century

Add-on combination therapy with monoclonal antibodies: Implications for drug development.

Authors: Cummings J Burstein AH Fillit H

Source: The journal of prevention of Alzheimer's disease [J Prev Alzheimers Dis] 2025 Dec; Vol. 12 (10), pp. 100359. Date of Electronic Publication: 2025 Oct 27.

Publication Type: Journal Article; Review

Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 101638820 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2426-0266 (Electronic) Linking ISSN: 22745807 NLM ISO Abbreviation: J Prev Alzheimers Dis Subsets: MEDLINE

MeSH Terms: Alzheimer Disease*/drug therapy , Drug Development* , Antibodies, Monoclonal*/therapeutic use, Humans ; Drug Therapy, Combination ; Amyloid beta-Peptides ; Antibodies, Monoclonal, Humanized/therapeutic use

History and Evolution of Innovations in Clinical Pharmacology.

Authors: Lesko LJ van der Graaf PH

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2025 Dec; Vol. 118 (6), pp. 1313-1328. Date of Electronic Publication: 2025 Sep 24.

Publication Type: Journal Article; Review; Historical Article

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

MeSH Terms: Pharmacology, Clinical*/history , Pharmacology, Clinical*/trends , Pharmacology, Clinical*/methods , Drug Development*/history , Drug Development*/methods , Drug Development*/trends , Drug Industry*/history , Drug Industry*/trends, Humans ; History, 21st Century ; History, 20th Century

Current Status on the Convergence of Artificial Intelligence and Formulation Development in Industry: A Review.

Authors: Warke S Katari O Jain S

Source: AAPS PharmSciTech [AAPS PharmSciTech] 2025 Nov 26; Vol. 27 (1), pp. 44. Date of Electronic Publication: 2025 Nov 26.

Publication Type: Journal Article; Review

Journal Info: Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932 (Electronic) Linking ISSN: 15309932 NLM ISO Abbreviation: AAPS PharmSciTech Subsets: MEDLINE

MeSH Terms: Artificial Intelligence*/trends , Drug Industry*/methods , Drug Industry*/trends , Drug Development*/methods , Drug Development*/trends , Drug Compounding*/methods, Humans ; Machine Learning ; Chemistry, Pharmaceutical/methods

Opportunities for AI-based Model-informed Drug Development: A Comparative Analysis of NONMEM and AI-based Models for Population Pharmacokinetic Prediction.

Authors: Mao B Gao Y Xu C et al.

Source: The AAPS journal [AAPS J] 2025 Nov 18; Vol. 28 (1), pp. 21. Date of Electronic Publication: 2025 Nov 18.

Publication Type: Journal Article; Comparative Study

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

MeSH Terms: Drug Development*/methods , Models, Biological* , Artificial Intelligence* , Pharmacokinetics*, Humans ; Nonlinear Dynamics ; Machine Learning ; Computer Simulation ; Deep Learning

Nature-Inspired Pathogen and Cancer Protein Covalent Inhibitors: From Plants and Other Natural Sources to Drug Development.

Authors: Roviello GN; Institute of Biostructures and Bioimaging, Italian National Research Council (IBB-CNR), Via P. Castellino 111, 80131 Naples, Italy.

Source: Pathogens (Basel, Switzerland) [Pathogens] 2025 Nov 12; Vol. 14 (11). Date of Electronic Publication: 2025 Nov 12.

Publication Type: Journal Article; Review

Journal Info: Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101596317 Publication Model: Electronic Cited Medium: Internet ISSN: 2076-0817 (Electronic) Linking ISSN: 20760817 NLM ISO Abbreviation: Pathogens Subsets: MEDLINE

MeSH Terms: Biological Products*/pharmacology , Biological Products*/chemistry , Drug Development* , Antineoplastic Agents*/pharmacology , Antineoplastic Agents*/chemistry , Plants*/chemistry , Neoplasms*/drug therapy , Anti-Infective Agents*/pharmacology , Anti-Infective Agents*/chemistry , Neoplasm Proteins*/antagonists & inhibitors, Humans ; Drug Discovery ; Fungi/chemistry ; Animals ; Bacteria/chemistry

Children's drug research and development incentives and market pricing optimization based on medical imaging.

Authors: Mu X Wu L

Source: Scientific reports [Sci Rep] 2025 Nov 06; Vol. 15 (1), pp. 38944. Date of Electronic Publication: 2025 Nov 06.

Publication Type: Journal Article

Journal Info: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE

MeSH Terms: Drug Development*/economics , Diagnostic Imaging*/economics, Humans ; Child ; Magnetic Resonance Imaging ; Tomography, X-Ray Computed ; Neural Networks, Computer ; Costs and Cost Analysis ; Motivation