Sökresultat - "Drug development"

Clinical pharmacology-how it shapes the drug development journey.

Kruse M; Parexel International GmbH, Berlin, Germany. matthias.kruse@parexel.com., Stankeviciute S; Parexel International UAB, Vilnius, Lithuania., Perry S; Parexel International Limited, Uxbridge, UK.

Journal Article; Review , 2025

Framework to identify innovative sources of value creation from platform technologies.

Jones CH; Pfizer, mRNA Commercial Strategy & Innovation, New York, NY 10018., Beitelshees M; Bulmore Consulting, Lockport, NY 14094., Hill A; Bulmore Consulting, Lockport, NY 14094., Griffiths D; Clearview Healthcare Partners, New York, NY 10001., Murphy M; Clearview Healthcare Partners, New York, NY 10001., Kapadia K; Clearview Healthcare Partners, New York, NY 10001., Dolsten M; Pfizer, mRNA Commercial Strategy & Innovation, New York, NY 10018., True JM; Pfizer, mRNA Commercial Strategy & Innovation, New York, NY 10018.

Journal Article; Systematic Review , 2025

The Role of Artificial Intelligence in Drug Discovery and Pharmaceutical Development: A Paradigm Shift in the History of Pharmaceutical Industries.

Vidiyala N; Small Molecule Drug Product Development, Cerevel Therapeutics, Cambridge, Massachusetts, 02141, USA., Sunkishala P; Process Validation, PCI Pharma Services, Bedford, New Hampshire, 03110, USA., Parupathi P; Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, New York, 11201, USA., Nyavanandi D; Small Molecule Drug Product Development, Cerevel Therapeutics, Cambridge, Massachusetts, 02141, USA. ndinesh624@gmail.com.

Journal Article; Review; Historical Article , 2025

Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.

Pasculli G; InSilicoTrials Technologies S.p.A., Trieste, Italy., Virgolin M; InSilicoTrials Technologies B.V., s-Hertogenbosch, the Netherlands., Myles P; Medicines and Healthcare products Regulatory Agency, London, UK., Vidovszky A; Unlearn.AI, San Francisco, California, USA., Fisher C; Unlearn.AI, San Francisco, California, USA., Biasin E; Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium., Mourby M; Centre for Health, Law, and Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, UK., Pappalardo F; Department of Drug and Health Sciences, University of Catania, Catania, Italy., D'Amico S; Humanitas Clinical and Research Center-IRCCS, Milan, Italy.; Train s.r.l., Milan, Italy., Torchia M; InSilicoTrials Technologies S.p.A., Trieste, Italy., Chebykin A; InSilicoTrials Technologies B.V., s-Hertogenbosch, the Netherlands., Carbone V; InSilicoTrials Technologies S.p.A., Trieste, Italy., Emili L; InSilicoTrials Technologies S.p.A., Trieste, Italy., Roeshammar D; InSilicoTrials Technologies S.p.A., Trieste, Italy.

Journal Article; Review , 2025

New discoveries in therapeutic targets and drug development pathways for type 2 diabetes mellitus under the guidance of precision medicine.

Tian X; School of Acupuncture-Moxibustion and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China., Wang L; Institute of Chinese Medical History and Literatures, China Academy of Chinese Medical Sciences, Beijing, 100700, China., Zhang L; Institute of Chinese Medical History and Literatures, China Academy of Chinese Medical Sciences, Beijing, 100700, China., Chen X; Institute of Chinese Medical Literature and Culture, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China., Wang W; China Academy of Chinese Medical Sciences, Xiyuan Hospital, Beijing, 100700, China., Zhang K; China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, 100700, China., Ge X; China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, 100700, China., Luo Z; China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, 100700, China., Zhai X; Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China. zhaixu@mail.cintcm.ac.cn., Shao H; Department of Special Examination, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China. Shq1969@163.com.

Journal Article; Review , 2025

Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review.

Mao B; Sanofi, Morristown, NJ, USA.; McWilliams School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, Texas, USA., Gao Y; Sanofi, Morristown, NJ, USA., Xu C; Sanofi, Morristown, NJ, USA., Macha S; Sanofi, Morristown, NJ, USA., Shao S; Sanofi, Morristown, NJ, USA. Shuai.Shao2@sanofi.com., Ahamadi M; Sanofi, Morristown, NJ, USA. malidi.ahamadi@sanofi.com.

Journal Article; Comparative Study; Review; Systematic Review , 2025

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

Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Pepin X; Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534, United States., Jamei M; Predictive Technologies, Certara U.K., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Sharma P; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge CB4 0WG, United Kingdom., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Wagner C; Global Drug Product Development, Global CMC Development, The Healthcare Business of Merck KGaA, Darmstadt 64293, Germany., Bransford P; Data and Computational Sciences, Vertex Pharmaceuticals Inc., Boston, Massachusetts 02210, United States., Kollipara S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, Telangana 500 090, India., Ahmed T; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, Telangana 500 090, India., Hingle M; Technical Research and Development, Novartis Pharma AG, 4051 Basel, Switzerland., Dallmann A; Bayer HealthCare SAS, Lille 59000, France., Scherholz M; Pharmaceutical Development, Bristol Myers Squibb, Route 206 and Province Line Road, Princeton, New Jersey 08543, United States., Stamatis SD; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285-0001, United States., Cano-Vega M; Drug Product Technologies, Amgen Inc., Thousand Oaks, California 91320, United States., Mistry N; Biopharmaceutics, Drug Product Development, Medicine Development and Supply, R&D, GSK, Ware SG12 0DP, United Kingdom., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 43183, Sweden., Borges L; Brazilian Health Regulatory Agency (ANVISA), Division of Therapeutic Equivalence (CETER), SIA Trecho 5 - Guará, Brasília, Federal District 71205-050, Brazil., Lindahl A; Swedish Medical Products Agency, Uppsala 752 37, Sweden., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States., Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Mitra A; Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts 02210, United States., Kushner J; Pfizer Inc, Groton, Connecticut 06340, United States., Harish Jain KM; Analytical Development and Operations, Gilead Sciences, 355 Lakeside Drive, Foster City, California 94404, United States., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States.

Journal Article; Review , 2025

Application of Real-World Evidence to Support FDA Regulatory Decision Making.

Khaowroongrueng V; Research Development and Innovation Department, The Government Pharmaceutical Organization, Bangkok, Thailand., Kim TE; Department of Clinical Pharmacology, Konkuk University Medical Center, Seoul, Republic of Korea., Park SI; Department of Pharmacology, College of Medicine, Kangwon National University, Chuncheon, Republic of Korea., Shin KH; College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, 41566, Republic of Korea. kshin@knu.ac.kr.; Infectious Disease Healthcare, Kyungpook National University, Daegu, 41566, Republic of Korea. kshin@knu.ac.kr.

Journal Article; Review , 2025

AI in fungal drug development: opportunities, challenges, and future outlook.

Li Y; College of Life and Health Sciences, Northeastern University, Shenyang, China., Qiao Y; College of Life and Health Sciences, Northeastern University, Shenyang, China., Ma Y; School of Public Health, Nantong University, Nantong, China., Xue P; School of Public Health, Nantong University, Nantong, China., Ding C; College of Life and Health Sciences, Northeastern University, Shenyang, China.

Journal Article; Review , 2025

Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance.

Duarte JG; Doctoral Program in Biomedical Sciences, School of Medicine & Biomedical Sciences, University of Porto (ICBAS-UP), Rua Jorge Viterbo Ferreira 228, 4050-513, Porto, Portugal., Duarte MG; Faculty of Pharmacy, University of Coimbra, Azinhaga Sta. Comba, 3000-548, Coimbra, Portugal., Piedade AP; University of Coimbra, CEMMPRE, Department of Mechanical Engineering, 3030-788, Coimbra, Portugal., Mascarenhas-Melo F; Higher School of Health, Polytechnic Institute of Guarda, Av. Dr. Francisco Sá Carneiro 50, 6300-559, Guarda, Guarda, Portugal. filipamelo@ff.uc.pt.; BRIDGES - Biotechnology Research, Innovation and Design for Health Products, Polytechnic University of Guarda, Avenida Dr. Francisco Sá Carneiro, N.º 50, 6300-559, Guarda, Portugal. filipamelo@ff.uc.pt.

Journal Article; Review , 2025

A Bayesian approach based on discounting factor for consistency assessment in multi-regional clinical trial.

Tong L; Department of Health Statistics, Faculty of Preventive Medicine, Air Force Medical University, Xi'an, Shaanxi, China.; Center for Disease Control and Prevention of Central Theater Command, Beijing, China., Li C; Department of Health Statistics, Faculty of Preventive Medicine, Air Force Medical University, Xi'an, Shaanxi, China.; Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, Xi'an, Shaanxi, China., Xia J; Department of Health Statistics, Faculty of Preventive Medicine, Air Force Medical University, Xi'an, Shaanxi, China.; Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, Xi'an, Shaanxi, China., Wang L; Department of Health Statistics, Faculty of Preventive Medicine, Air Force Medical University, Xi'an, Shaanxi, China.; Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, Xi'an, Shaanxi, China.

Journal Article , 2025

Use of real-world data for the development and the follow-up of drugs in rare diseases. The example of immune thrombocytopenia and autoimmune hemolytic anemia.

Moulis G; Service de médecine interne, centre de référence constitutif des cytopénies auto-immunes de l'adultes, CHU de Toulouse, Toulouse, France; CIC 1436, CHU de Toulouse, Toulouse, France. Electronic address: moulis.g@chu-toulouse.fr., Zadro Y; Service de médecine interne, centre de référence constitutif des cytopénies auto-immunes de l'adultes, CHU de Toulouse, Toulouse, France; CIC 1436, CHU de Toulouse, Toulouse, France., Sommet A; CIC 1436, CHU de Toulouse, Toulouse, France; Service de pharmacologie médicale et clinique, CHU de Toulouse, Toulouse, France., Lapeyre-Mestre M; CIC 1436, CHU de Toulouse, Toulouse, France; Service de pharmacologie médicale et clinique, CHU de Toulouse, Toulouse, France., Lafaurie M; CIC 1436, CHU de Toulouse, Toulouse, France; Service de pharmacologie médicale et clinique, CHU de Toulouse, Toulouse, France.

Journal Article; Review , 2025

Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints.

Luo X; Biometrics, Sarepta Therapeutics, Cambridge, Massachusetts, USA., Li L; Biometrics, Sarepta Therapeutics, Cambridge, Massachusetts, USA., Savenkov O; Biometrics, Sarepta Therapeutics, Cambridge, Massachusetts, USA., Liu W; Biometrics, Sarepta Therapeutics, Cambridge, Massachusetts, USA., Ni X; Biometrics, Sarepta Therapeutics, Cambridge, Massachusetts, USA., Tang W; Biometrics, Sarepta Therapeutics, Cambridge, Massachusetts, USA., Guo W; Department of Mathematical Sciences, New Jersey Institute of Technology, University Heights, Newark, New Jersey, USA.

Journal Article , 2025

Importance of Health Economics and Outcomes Research in the Product Lifecycle.

Dang A; Founder and CEO, MarksMan Healthcare Communications, J1309, Amethyst Tower, PBEL City, Peeramcheruvu Village, Rajendra Nagar Mandal, Hyderabad, Telangana, 500091, India. amit.d@marksmanhealthcare.com.

Journal Article; Review , 2025

Regulatory, Translational, and Operational Considerations for the Incorporation of Biomarkers in Drug Development.

Hatcher H; Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA., Stankeviciute S; Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA., Learn C; Cell and Gene Therapy Center of Excellence, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA. chris.learn@parexel.com., Qu AX; Biomarkers and Genomic Medicine, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA.

Journal Article; Review , 2025

The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis.

Xie RZ; RA Capital Management, 200 Berkeley Street, 18th Floor, Boston, MA, 02116, USA. rxie@racap.com., Cameron T; RA Capital Management, 200 Berkeley Street, 18th Floor, Boston, MA, 02116, USA., Kolchinsky P; RA Capital Management, 200 Berkeley Street, 18th Floor, Boston, MA, 02116, USA.

Journal Article , 2025

The need to consider market access for pharmaceutical investment decisions: a primer.

Ramagopalan SV; Centre for Pharmaceutical Medicine Research, King's College London, London, SE1 9NH, UK., Bacon C; Fingerpost Consulting, Pure Offices, Cheadle Royal Business Park, Brooks Drive, Cheadle, Manchester, SK8 3TD, UK., Walker M; Founder & CEO, Access InVivo, London, UK., Ryan ML; Founder & CEO, Koios Enterprises & Consulting, USA.; Executive Advisor, Numerof & Associates, USA.

Journal Article; Editorial , 2025

Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide.

Sychterz C; Bristol Myers Squibb, Princeton, New Jersey, USA., Chen P; Bristol Myers Squibb, Princeton, New Jersey, USA.; Bristol Myers Squibb, 556 Morris Ave, Summit, New Jersey, 07901, USA., Saxena A; Bristol Myers Squibb, Princeton, New Jersey, USA., Lin H; Bristol Myers Squibb, Princeton, New Jersey, USA., Chen L; Bristol Myers Squibb, Princeton, New Jersey, USA., Li Y; Bristol Myers Squibb, Princeton, New Jersey, USA.; Bristol Myers Squibb, 556 Morris Ave, Summit, New Jersey, 07901, USA., Gaohua L; Bristol Myers Squibb, Princeton, New Jersey, USA., Cheng Y; Bristol Myers Squibb, Princeton, New Jersey, USA. yiming.cheng@bms.com.; Bristol Myers Squibb, 556 Morris Ave, Summit, New Jersey, 07901, USA. yiming.cheng@bms.com.

Journal Article , 2025

Recent Advances in Drug Development for Hair Loss.

Kim J; New Hair Institute, Seoul 06034, Republic of Korea., Song SY; Institute for Human Tissue Restoration, Department of Plastic and Reconstructive Surgery, Yonsei University College of Medicine, Seoul 06134, Republic of Korea., Sung JH; Epi Biotech Co., Ltd., Incheon 21983, Republic of Korea.

Journal Article; Review , 2025

Enhancing clinical trial outcome prediction with artificial intelligence: a systematic review.

Qian L; Faculty of Computing Engineering Media, De Montfort University, Leicester, UK., Lu X; Faculty of Computing Engineering Media, De Montfort University, Leicester, UK., Haris P; Faculty of Health & Life Sciences, De Montfort University, Leicester, UK., Zhu J; Scitops Corporation, Shanghai, China., Li S; Faculty of Computing Engineering Media, De Montfort University, Leicester, UK., Yang Y; Faculty of Computing Engineering Media, De Montfort University, Leicester, UK. Electronic address: yyang@dmu.ac.uk.

Journal Article; Systematic Review , 2025