المؤلفون: Tomlinson L; Global Pathology, Pfizer Inc., Cambridge, MA, 02140, USA., Ramsden D; DMPK Oncology, AstraZeneca, Boston, MA, 02451, USA., Leite SB; European Commission Joint Research Centre, Ispra, 21027, Italy., Beken S; Federal Agency for Medicines and Health Products, Brussels, 1210, Belgium., Bonzo JA; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Brown P; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Candarlioglu PL; Complex In Vitro Models, GSK, Stevenage, SG1 2NY, UK., Chan TS; Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, 06877, USA., Chen E; DMPK, Genentech, South San Francisco, CA, 94080, USA., Choi CK; Preclinical Safety, Biogen, Cambridge, MA, 02142, USA., David R; Clinical Pharmacology & Safety Sciences, AstraZeneca, Cambridge, CB2 0AA, UK., Delrue N; Organisation for Economic Co-operation and Development, Paris, 75016, France., Devine PJ; Discovery Toxicology, Bristol Myers Squibb, San Diego, CA, 09130, USA., Ford K; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Garcia MI; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Gosset JR; DMPK, Pfizer Inc., Cambridge, MA, 02139, USA., Hewitt P; Chemical and Preclinical Safety, Merck Healthcare KGaA, 64293, Darmstadt, Germany., Homan K; Complex in Vitro Systems Group, Genentech, South San Francisco, CA, 94080, USA., Irrechukwu O; Preclinical Sciences and Translational Safety, Johnson and Johnson Innovation Medicine, Spring House, PA, 19002, USA., Kopec AK; Drug Safety Research & Development, Pfizer Inc., Groton, CT, 06340, USA., Liras JL; Pharmacokinetics, Dynamics & Metabolism-Medicine Design, Pfizer, Cambridge, MA, 02139, USA., Mandlekar S; Clinical Pharmacology, Genentech, South San Francisco, CA, 94080, USA., Raczynski A; Preclinical Safety Assessment, Vertex Pharmaceuticals Inc., Boston, MA, 02210, USA., Sadrieh N; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Sakatis MZ; Non-Clinical Safety, In Vitro/In Vivo Translation, GSK R&D, Ware, SG12 9TJ, UK., Siegel J; Center for Drug Evaluation and Research, Office of New Drugs, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Sung K; Center for Biologics Evaluation and Research, Office of Cellular Therapy and Human Tissue, Cellular and Tissue Therapy Branch, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Sunyovszki I; Translational Cellular Sciences, Biogen, Cambridge, MA, 02142, USA., Van Vleet TR; AbbVie, Inc., North Chicago, IL, 60064, USA., Ekert JE; UCB Pharma, Cambridge, MA, 02140, USA., Hardwick RN; Discovery Toxicology, Bristol Myers Squibb, San Diego, CA, 09130, USA.

المصدر: Advanced biology [Adv Biol (Weinh)] 2024 Aug; Vol. 8 (8), pp. e2300131. Date of Electronic Publication: 2023 Oct 09.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Wiley-VCH GmbH Country of Publication: Germany NLM ID: 101775319 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2701-0198 (Electronic) Linking ISSN: 27010198 NLM ISO Abbreviation: Adv Biol (Weinh) Subsets: MEDLINE

مواضيع طبية MeSH: Drug Industry*/legislation & jurisprudence , Drug Industry*/standards , Drug Development*/legislation & jurisprudence , Drug Development*/standards, Humans ; United States ; United States Food and Drug Administration/legislation & jurisprudence ; United States Food and Drug Administration/standards

المؤلفون: Nene L; Department of Pharmacology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa., Flepisi BT; Department of Pharmacology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa., Brand SJ; Center of Excellence for Pharmaceutical Sciences, Department of Pharmacology, North-West University, Potchefstroom, South Africa., Basson C; Department of Physiology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa., Balmith M; Department of Pharmacology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa. Electronic address: marissa.balmith@up.ac.za.

المصدر: Clinical therapeutics [Clin Ther] 2024 Aug; Vol. 46 (8), pp. e6-e14. Date of Electronic Publication: 2024 Jul 08.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Excerpta Medica Country of Publication: United States NLM ID: 7706726 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-114X (Electronic) Linking ISSN: 01492918 NLM ISO Abbreviation: Clin Ther Subsets: MEDLINE

مواضيع طبية MeSH: Drug Development*/legislation & jurisprudence , Drug Development*/methods , Artificial Intelligence*, Humans ; Deep Learning ; Machine Learning ; Natural Language Processing

المؤلفون: Zhang Y; College of Science, Harbin Institute of Technology (Shenzhen), Shenzhen, Guangdong, China; School of Medicine, The Chinese University of Hong Kong (Shenzhen), Shenzhen, Guangdong, China., Mastouri M; College of Science, Harbin Institute of Technology (Shenzhen), Shenzhen, Guangdong, China., Zhang Y; College of Science, Harbin Institute of Technology (Shenzhen), Shenzhen, Guangdong, China. Electronic address: zhangyang07@hit.edu.cn.

المصدر: Med (New York, N.Y.) [Med] 2024 Sep 13; Vol. 5 (9), pp. 1050-1070. Date of Electronic Publication: 2024 Aug 21.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Cell Press Country of Publication: United States NLM ID: 101769215 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2666-6340 (Electronic) Linking ISSN: 26666340 NLM ISO Abbreviation: Med Subsets: MEDLINE

مواضيع طبية MeSH: Artificial Intelligence* , Drug Discovery*/methods , Drug Development*/methods , Clinical Trials as Topic*/methods, Humans

المؤلفون: Miesle JE; Synthetic Molecule Design and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. miesleje@lilly.com., Osei-Yeboah F; Pharmaceutical Development, Biogen, Cambridge, MA, USA., Pauli-Bruns A; Biologics Drug Product Development, Sanofi, Frankfurt, Germany., Chen B; Product Development Science & Technology, Abbvie, North Chicago, IL, USA., Manceva S; Biologics Drug Product Development, Teva Branded Pharmaceuticals, West Chester, PA, USA., Wade JB; Technical Services/Manufacturing Science, Eli Lilly and Company, Indianapolis, IN, USA., Yin S; Drug Product Development, BMS, New Brunswick, NJ, USA., Desai D; Drug Product Development, BMS, New Brunswick, NJ, USA., Dirat O; Global Regulatory Sciences - CMC Advisory Office, Pfizer, Sandwich, UK., Bhugra C; Drug Product Development, GSK, Collegeville, PA, USA., Stauffer F; UCB Pharma, Brussels, Belgium.

المصدر: Pharmaceutical research [Pharm Res] 2024 Sep; Vol. 41 (9), pp. 1775-1786. Date of Electronic Publication: 2024 Sep 04.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE

مواضيع طبية MeSH: Drug Industry*/methods , Drug Development*/methods , Drug Development*/legislation & jurisprudence, Surveys and Questionnaires ; Humans ; Pharmaceutical Preparations/chemistry ; Drug Design ; Quality Control

المؤلفون: Mullard A

المصدر: Nature reviews. Drug discovery [Nat Rev Drug Discov] 2024 Sep; Vol. 23 (9), pp. 650.

نوع المنشور: News; Journal Article

بيانات الدورية: Publisher: Nature Pub. Group Country of Publication: England NLM ID: 101124171 Publication Model: Print Cited Medium: Internet ISSN: 1474-1784 (Electronic) Linking ISSN: 14741776 NLM ISO Abbreviation: Nat Rev Drug Discov Subsets: MEDLINE

مواضيع طبية MeSH: Drug Development*/economics , Drug Development*/methods, Humans ; Drug Costs ; Cost-Benefit Analysis/methods

المؤلفون: West J; Keck Graduate Institute, 535 Watson Drive, Claremont, CA 91711, USA., Olk P; Daniels College of Business, Denver University, 2101 S. University Blvd., Denver, CO 80208, USA. Electronic address: Paul.Olk@du.edu.

المصدر: Drug discovery today [Drug Discov Today] 2024 Sep; Vol. 29 (9), pp. 104103. Date of Electronic Publication: 2024 Jul 15.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Elsevier Science Ltd. Country of Publication: England NLM ID: 9604391 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5832 (Electronic) Linking ISSN: 13596446 NLM ISO Abbreviation: Drug Discov Today Subsets: MEDLINE

مواضيع طبية MeSH: Alzheimer Disease*/drug therapy , Drug Development*/methods , Public-Private Sector Partnerships*, Humans ; Cooperative Behavior

المؤلفون: Smith ZP; Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. zachary.smith605922@tufts.edu., DiMasi JA; Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA., Getz KA; Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Sep; Vol. 58 (5), pp. 855-862. Date of Electronic Publication: 2024 May 21.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Drug Development*/economics, Humans ; Clinical Trials as Topic/economics ; Prescription Drugs/economics ; Time Factors ; Commerce/economics

المؤلفون: Hill A; Pfizer, 66 Hudson Boulevard, New York, NY 10001, USA., True JM; Pfizer, 66 Hudson Boulevard, New York, NY 10001, USA., Jones CH; Pfizer, 66 Hudson Boulevard, New York, NY 10001, USA. Electronic address: charles.jones@pfizer.com.

المصدر: Trends in biotechnology [Trends Biotechnol] 2024 Sep; Vol. 42 (9), pp. 1072-1075. Date of Electronic Publication: 2024 Feb 20.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Elsevier Science Publishers Country of Publication: England NLM ID: 8310903 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-3096 (Electronic) Linking ISSN: 01677799 NLM ISO Abbreviation: Trends Biotechnol Subsets: MEDLINE

مواضيع طبية MeSH: Artificial Intelligence* , Synthetic Biology*/methods , Synthetic Biology*/trends , Drug Development*/methods, Humans ; COVID-19/virology ; SARS-CoV-2/genetics ; SARS-CoV-2/drug effects ; COVID-19 Drug Treatment ; Pandemics

المؤلفون: Rahman A; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA., Shah M; Division of Oncology I, Office of Oncologic Diseases, Office of New Drugs, CDER, US Food and Drug Administration, Silver Spring, Maryland, USA., Shord SS; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.

المصدر: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Sep; Vol. 116 (3), pp. 577-591. Date of Electronic Publication: 2024 Jul 29.

نوع المنشور: Journal Article; Review

بيانات الدورية: 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

مواضيع طبية MeSH: Antineoplastic Agents*/administration & dosage , Antineoplastic Agents*/therapeutic use , Antineoplastic Agents*/adverse effects , Drug Development*/legislation & jurisprudence , Drug Development*/methods , Neoplasms*/drug therapy , Drug Approval*/legislation & jurisprudence, Humans ; Dose-Response Relationship, Drug ; Drug Dosage Calculations

المؤلفون: Singh R; Pfizer Research and Development, 10555 Science Center Dr, San Diego, CA, 92121, USA. drugdevpro@gmail.com., Wang W; Merck & Co., Inc, 126 East Lincoln Ave, Rahway, NJ, 07065, USA., Chakravarty A; Pfizer Chief Medical Affairs Office, 66 Hudson Boulevard, New York, NY, 10001, USA., Wang J; Center of Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Economic and Technological Development Zone, Beijing, China., Uyama Y; Regulatory Science Center, Pharmaceuticals and Medical Devices Agency, Shin‑Kasumigaseki Building, 3‑3‑2, Kasumigaseki, Chiyoda‑ku, Tokyo, 100‑0013, Japan.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Sep; Vol. 58 (5), pp. 845-854. Date of Electronic Publication: 2024 May 12.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Drug Development*/legislation & jurisprudence, Humans ; Clinical Trials as Topic ; Guidelines as Topic ; Multicenter Studies as Topic ; COVID-19