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...

Full description

Saved in:

Bibliographic Details
Published in:	European journal of clinical pharmacology Vol. 76; no. 9; pp. 1237 - 1243
Main Authors:	Mishra, Archana, Sarangi, Sudhir Chandra, Reeta, Kh
Format:	Journal Article
Language:	English
Published:	Berlin/Heidelberg Springer Berlin Heidelberg 01.09.2020 Springer Nature B.V
Subjects:	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 Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Be the first to leave a comment!