First-in-human dose: current status review for better future perspectives

Aim The aim of this article is to understand the pros and cons of various methods involved in first-in-human (FIH) dose calculation and act decisively in dose escalations when calculating the maximum tolerated dose. Subjects and methods We reviewed early phase clinical trials for methods of FIH dose...

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Veröffentlicht in:	European journal of clinical pharmacology Jg. 76; H. 9; S. 1237 - 1243
Hauptverfasser:	Mishra, Archana, Sarangi, Sudhir Chandra, Reeta, Kh
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Berlin/Heidelberg Springer Berlin Heidelberg 01.09.2020 Springer Nature B.V
Schlagworte:	Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Biomedical and Life Sciences Biomedicine Clinical Trial Clinical trials Clinical Trials, Phase I as Topic - methods Clinical Trials, Phase I as Topic - standards Cyclic N-Oxides - administration & dosage Cyclic N-Oxides - adverse effects Developmental stages Dose-Response Relationship, Drug Drug development Drug dosages Humans Maximum Tolerated Dose Pharmaceutical Preparations - administration & dosage Pharmacodynamics Pharmacokinetics Pharmacology/Toxicology Pyridines - administration & dosage Pyridines - adverse effects Research Design Reviews PK/PD modelling Phase 1 Dose escalation First-in-human dose MABEL NOAEL
ISSN:	0031-6970, 1432-1041, 1432-1041
Online-Zugang:	Volltext
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