Innovative early development regulatory approaches: expIND, expCTA, microdosing.

Innovative early development regulatory approaches: expIND, expCTA, microdosing.

Item
http://www.wikidata.org/entity/Q37037370
Evaluation of agile designs in first-in-human (FIH) trials--a simulation studyThe European and American use of exploratory approaches for first-in-human studies.Phase 0 clinical trials: recommendations from the Task Force on Methodology for the Development of Innovative Cancer TherapiesPhase 0 clinical trials in oncology new drug development.HIV protease inhibitors in pulmonary hypertension: rationale and design of a pilot trial in idiopathic pulmonary arterial hypertension.Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patientDesigning phase 0 cancer clinical trials.Phase 0 clinical studies in oncology.Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies.Microdosing studies using accelerated mass spectrometry as exploratory investigational new drug trials.PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications.Role of Phase 0 trials in drug development.Case studies addressing human pharmacokinetic uncertainty using a combination of pharmacokinetic simulation and alternative first in human paradigms.Biomedical accelerator mass spectrometry: recent applications in metabolism and pharmacokineticsBiomedical Conventions and Regulatory Objectivity
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Innovative early development regulatory approaches: expIND, expCTA, microdosing.

Item
http://www.wikidata.org/entity/Q37037370
description
article científic
@ca
article scientifique
@fr
articolo scientifico
@it
artigo científico
@pt
bilimsel makale
@tr
scientific article published on 19 December 2007
@en
vedecký článok
@sk
vetenskaplig artikel
@sv
videnskabelig artikel
@da
vědecký článek
@cs
name
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@en
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@nl
type
label
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@en
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@nl
prefLabel
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@en
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@nl
P1433
P1476
P2093
P2888
P304
P31
P356
P407
P433
P478
P577
P5875
P6179
P698
P356
P1433
P1476
Innovative early development regulatory approaches: expIND, expCTA, microdosing.
@en
P2093
P2888
P304
P31
P356
P407
P433
P478
P577
P5875
P6179
P698