المؤلفون: Schmid A; Albstadt-Sigmaringen University, Sigmaringen, Germany. schmida@hs-albsig.de.

المصدر: Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2024; Vol. 2786, pp. 321-337.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Humana Press Country of Publication: United States NLM ID: 9214969 Publication Model: Print Cited Medium: Internet ISSN: 1940-6029 (Electronic) Linking ISSN: 10643745 NLM ISO Abbreviation: Methods Mol Biol Subsets: MEDLINE

مواضيع طبية MeSH: Clinical Trials as Topic* , mRNA Vaccines* , Quality Control*, Humans ; RNA, Messenger/genetics ; United States ; Investigational New Drug Application ; Vaccines, Synthetic

المؤلفون: Jha BS; Center for Cell Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA., Farnoodian M; Ocular and Stem Cell Translational Research Section, Ophthalmic Genetics and Visual Function Branch, National Eye Institute, National Institutes of Health, Bethesda, Maryland, USA., Bharti K; Ocular and Stem Cell Translational Research Section, Ophthalmic Genetics and Visual Function Branch, National Eye Institute, National Institutes of Health, Bethesda, Maryland, USA.

المصدر: Stem cells translational medicine [Stem Cells Transl Med] 2021 Feb; Vol. 10 (2), pp. 198-208. Date of Electronic Publication: 2020 Sep 18.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Oxford University Press Country of Publication: England NLM ID: 101578022 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2157-6580 (Electronic) Linking ISSN: 21576564 NLM ISO Abbreviation: Stem Cells Transl Med Subsets: MEDLINE

مواضيع طبية MeSH: Induced Pluripotent Stem Cells* , Investigational New Drug Application*, Regenerative Medicine/*legislation & jurisprudence , Transplantation, Autologous/*legislation & jurisprudence, Cell Differentiation ; Humans

المؤلفون: Lu J; Center for Drug Evaluation (CDE), National Medical Products Administration, Beijing, 100022, China. Electronic address: lujq@cde.org.cn., Wei W; Center for Drug Evaluation (CDE), National Medical Products Administration, Beijing, 100022, China.

المصدر: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Nov; Vol. 68, pp. 3-8. Date of Electronic Publication: 2020 Oct 20.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Academic Press Country of Publication: England NLM ID: 9004494 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-8320 (Electronic) Linking ISSN: 10451056 NLM ISO Abbreviation: Biologicals Subsets: MEDLINE

مواضيع طبية MeSH: Cell Differentiation*, Cell- and Tissue-Based Therapy/*methods , Investigational New Drug Application/*methods , Mesenchymal Stem Cells/*cytology , Pluripotent Stem Cells/*cytology, Cell- and Tissue-Based Therapy/standards ; Chemistry, Pharmaceutical/methods ; China ; Drug Approval/methods ; Humans ; Investigational New Drug Application/legislation & jurisprudence ; Mesenchymal Stem Cells/chemistry ; Pluripotent Stem Cells/chemistry ; Quality Control

المؤلفون: Johnson LM; St. Jude Children's Research Hospital., Duenas DM; Seattle Children's Research Institute., Wilfond BS; Seattle Children's Research Institute.; University of Washington School of Medicine.

المصدر: The American journal of bioethics : AJOB [Am J Bioeth] 2020 May; Vol. 20 (4), pp. 111-113.

نوع المنشور: Case Reports; Journal Article

بيانات الدورية: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 100898738 Publication Model: Print Cited Medium: Internet ISSN: 1536-0075 (Electronic) Linking ISSN: 15265161 NLM ISO Abbreviation: Am J Bioeth Subsets: MEDLINE

مواضيع طبية MeSH: Clinical Trial Protocols as Topic* , Ethics, Research* , Investigational New Drug Application* , Research Design*, Clinical Trials as Topic/*ethics , Drug Development/*ethics, Adolescent ; Humans ; Lupus Erythematosus, Systemic/prevention & control ; Minors ; Rare Diseases/prevention & control ; Risk ; United States ; United States Food and Drug Administration

المؤلفون: Wu C; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Lee SL; Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Taylor C; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Li J; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Chan YM; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Agarwal R; New Drug Products Branch II, Division of New Drug Products I, Office of New Drug Products, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Temple R; Office of the Center Director , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Throckmorton D; Office of the Center Director , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Tyner K; Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States.

المصدر: Journal of natural products [J Nat Prod] 2020 Feb 28; Vol. 83 (2), pp. 552-562. Date of Electronic Publication: 2020 Jan 24.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: American Society of Pharmacognosy Country of Publication: United States NLM ID: 7906882 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6025 (Electronic) Linking ISSN: 01633864 NLM ISO Abbreviation: J Nat Prod Subsets: MEDLINE

مواضيع طبية MeSH: Investigational New Drug Application*, Proanthocyanidins/*chemistry, Humans ; Molecular Structure ; Pharmaceutical Preparations ; United States

عنوان ترانسليتريتد: Nouvelles modalités de prescription des autorisations temporaires d’utilisation nominatives (ATUn) : une étape clé dans l’accès à l’innovation.

المؤلفون: Vignot S; Agence nationale de sécurité du médicament et des produits de santé (ANSM), 143-147, boulevard Anatole France, 93285 Saint-Denis cedex, France. Electronic address: stephane.vignot@ansm.sante.fr., Chapel E; Agence nationale de sécurité du médicament et des produits de santé (ANSM), 143-147, boulevard Anatole France, 93285 Saint-Denis cedex, France.

المصدر: Bulletin du cancer [Bull Cancer] 2019 Nov; Vol. 106 (11), pp. 943-945. Date of Electronic Publication: 2019 Sep 25.

نوع المنشور: Editorial

بيانات الدورية: Publisher: Elsevier Country of Publication: France NLM ID: 0072416 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1769-6917 (Electronic) Linking ISSN: 00074551 NLM ISO Abbreviation: Bull Cancer Subsets: MEDLINE

مواضيع طبية MeSH: Diffusion of Innovation* , Investigational New Drug Application* , Therapies, Investigational*, Antineoplastic Agents/therapeutic use ; Antineoplastic Agents, Immunological/therapeutic use ; Clinical Trials as Topic ; Europe ; Hematologic Agents/therapeutic use ; Humans

المؤلفون: Wang A; National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd., Tianjin, 300457, China.; Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, Tianjin, 300457, China., Zhang L; The Postdoctoral Research Station, School of Medicine, Nankai University, Tianjin, 300071, China.; Institute of Stem Cells, Health- Biotech (Tianjin) Stem Cell Research Institute Co., Ltd., Tianjin, 301700, China.; Key Laboratory of Radiation Technology and Biophysics, Institute of Biology & Hefei Institute of Physical Science, Chinese Academy of Sciences, Hefei, 230031, China.; Key Laboratory of Molecular Diagnostics and Precision Medicine for Surgical Oncology in Gansu Province & NHC Key Laboratory of Diagnosis and Therapy of Gastrointestinal Tumor, Gansu Provincial Hospital, Lanzhou, 730000, China., Zhao M; National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd., Tianjin, 300457, China.; Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, Tianjin, 300457, China., Yu H; National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd., Tianjin, 300457, China.; Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, Tianjin, 300457, China.; The Postdoctoral Research Station, School of Medicine, Nankai University, Tianjin, 300071, China.

المصدر: Current stem cell research & therapy [Curr Stem Cell Res Ther] 2023; Vol. 18 (8), pp. 1032-1040.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Bentham Science Publishers Country of Publication: United Arab Emirates NLM ID: 101272517 Publication Model: Print Cited Medium: Internet ISSN: 2212-3946 (Electronic) Linking ISSN: 1574888X NLM ISO Abbreviation: Curr Stem Cell Res Ther Subsets: MEDLINE

مواضيع طبية MeSH: Graft vs Host Disease*/therapy , Hematopoietic Stem Cell Transplantation* , Mesenchymal Stem Cells* , Mesenchymal Stem Cell Transplantation*, Humans ; Investigational New Drug Application ; Immunomodulation

المؤلفون: Scott C; Division of Applied Regulatory Science, Food and Drug Administration, Silver Spring, MD 20993, USA; Oak Ridge Institute for Science and Education, Oak Ridge, TN 37830, USA., Dodson A; Division of Applied Regulatory Science, Food and Drug Administration, Silver Spring, MD 20993, USA; Oak Ridge Institute for Science and Education, Oak Ridge, TN 37830, USA., Saulnier M; Office of New Drugs, Food and Drug Administration, Silver Spring, MD 20993, USA., Snyder K; Office of New Drugs, Food and Drug Administration, Silver Spring, MD 20993, USA., Racz R; Division of Applied Regulatory Science, Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: Rebecca.Racz@fda.hhs.gov.

المصدر: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2022 Sep-Oct; Vol. 117, pp. 107205. Date of Electronic Publication: 2022 Aug 01.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 9206091 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-488X (Electronic) Linking ISSN: 10568719 NLM ISO Abbreviation: J Pharmacol Toxicol Methods Subsets: MEDLINE

مواضيع طبية MeSH: Drugs, Investigational* , Vesicular Monoamine Transport Proteins*, Histamine ; Humans ; Investigational New Drug Application/methods ; United States ; United States Food and Drug Administration

المؤلفون: Saka H; Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi., Oki M; Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi., Kitagawa C; Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi., Kogure Y; Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi., Kojima Y; Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi., Saito AM; Clinical Research Center, National Hospital Organization, Nagoya Medical Center, Aichi., Ishida A; Department of Respiratory/Infectious Diseases, St. Marianna University School of Medicine Hospital, Kanagawa., Miyazawa T; Department of Respiratory/Infectious Diseases, St. Marianna University School of Medicine Hospital, Kanagawa., Takeda K; Department of Medical Oncology, Osaka City General Hospital, Osaka., Nakagawa K; Department of Medical Oncology, Kindai University Hospital, Osaka., Sasada S; Department of Respiratory Medicine, Tokyo Saiseikai Central Hospital, Tokyo., Negoro S; Department of Medical Oncology, Hyogo Cancer Center, Hyogo, Japan.

المصدر: Japanese journal of clinical oncology [Jpn J Clin Oncol] 2018 Apr 01; Vol. 48 (4), pp. 376-381.

نوع المنشور: Clinical Trial, Phase II; Journal Article

بيانات الدورية: Publisher: Oxford University Press Country of Publication: England NLM ID: 0313225 Publication Model: Print Cited Medium: Internet ISSN: 1465-3621 (Electronic) Linking ISSN: 03682811 NLM ISO Abbreviation: Jpn J Clin Oncol Subsets: MEDLINE

مواضيع طبية MeSH: Investigational New Drug Application* , Pleurodesis*/adverse effects , Sterilization*, Pleural Effusion, Malignant/*therapy , Talc/*therapeutic use, Adult ; Aged ; Endpoint Determination ; Female ; Humans ; Japan ; Male ; Middle Aged ; Talc/adverse effects ; Treatment Outcome

المؤلفون: Baldrick P; Product Development and Market Access Consulting, Clinical Development & Commercialisation Services, Labcorp Drug Development Inc. (formerly Covance), Harrogate, North Yorkshire, HG3 1PY, United Kingdom. Electronic address: paul.baldrick@covance.com.

المصدر: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2022 Apr; Vol. 130, pp. 105130. Date of Electronic Publication: 2022 Feb 04.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE

مواضيع طبية MeSH: Interprofessional Relations*, Drug Approval/*organization & administration , Government Agencies/*organization & administration, Europe ; Humans ; Investigational New Drug Application/organization & administration ; Marketing/organization & administration