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First in Human

Known as: firstInHuman 
The first time an active substance or agent is administered to a human during a study.
National Institutes of Health

Papers overview

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2018
2018
Abstract CT072: First in human (FIH) dose escalation studies of intravenous administration of VSV-IFNβ-NIS (Voyager-V1™) in Stage IV or recurrent endometrial cancer
Introduction. VSV-IFNβ-NIS is an oncolytic vesicular stomatitis virus (VSV; Rhabdovirus family) with rapid replication kinetics… Expand
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2017
2017
Commentary: Why Pharmaceutical Scientists in Early Drug Discovery Are Critical for Influencing the Design and Selection of Optimal Drug Candidates
This commentary reflects the collective view of pharmaceutical scientists from four different organizations with extensive… Expand
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2017
2017
Accelerating patient access to novel biologics using stable pool‐derived product for non‐clinical studies and single clone‐derived product for clinical studies
Cell cloning and subsequent process development activities are on the critical path directly impacting the timeline for… Expand
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2017
2017
Comparative study of therapeutic antibody candidates derived from mini‐pool and clonal cell lines
The long journey of developing a drug from initial discovery target identification to regulatory approval often leaves many… Expand
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2016
2016
First in human (FIH) study of an OX40 agonist monoclonal antibody (mAb) PF-04518600 (PF-8600) in adult patients (pts) with select advanced solid tumors: Preliminary safety and pharmacokinetic (PK…
3079Background: Stimulating effector T cells is an attractive anti-cancer therapeutic strategy. PF-8600 is a novel fully human… Expand
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2016
2016
Adding value through accelerator mass spectrometry-enabled first in human studies.
Accelerator mass spectrometry (AMS) is an ultra-sensitive technique for the analysis of radiocarbon. It is applicable to… Expand
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2016
2016
The evolution of drug design at Merck Research Laboratories
On October 5, 1981, Fortune magazine published a cover article entitled the “Next Industrial Revolution: Designing Drugs by… Expand
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2015
2015
First in human nanotechnology doxorubicin delivery system to target epidermal growth factor receptors in recurrent glioblastoma
There are limited treatment options for patients with recurrent glioblastoma (GBM). The EnGeneIC delivery vehicle (EDV) is a… Expand
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2011
2011
Innovation in safety pharmacology testing.
This issue of the Journal of Pharmacological and Toxicological Methods (JPTM) is themed. It is the eighth in a series, arising… Expand
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2010
2010
Phase 1 study of conatumumab, a pro-apoptotic death receptor 5 agonist antibody, in Japanese patients with advanced solid tumors
PurposeConatumumab is a fully human monoclonal agonist antibody against human death receptor 5 (DR5). The primary objectives of… Expand
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