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標籤: fih
此標籤下有 30 條筆記。
2026年5月02日
FIH Oncology Drug Development Wiki
fih
index
oncology
2026年5月02日
ADC Dose Selection and Regimen Optimization
fih
adc
dose-optimization
project-optimus
rp2d
schedule
pk-variability
midd
2026年5月02日
ADC FIH Case Studies: B7-H3, HER2, and TROP-2
fih
adc
b7h3
her2
trop2
ild
biomarker
case-study
dose-escalation
2026年5月02日
ADC FIH: Clinical Pharmacology Framework
fih
adc
clinical-pharmacology
pk-pd
exposure-response
bioanalysis
2026年5月02日
Backfill Strategies and Adaptive Randomization for Dose Optimization
fih
statistics
bayesian
backfill
adaptive-randomization
dose-optimization
project-optimus
phase-i
2026年5月02日
BOIN Safety Rules: 'Cleared for Escalation' Is Not 'Declared Safe'
fih
statistics
bayesian
boin
dose-escalation
safety
intra-patient
phase-i
2026年5月02日
Clinician Teaching Module: Reading FIH Trials as Three Parallel Lines
fih
teaching
clinical-education
dose-optimization
translational
2026年5月02日
ctDNA as a Translational Endpoint in FIH Oncology Trials
fih
biomarker
ctdna
translational-endpoint
proof-of-mechanism
dose-optimization
2026年5月02日
ctDNA-Informed Dose Finding: From Exploratory Appendix to Decision Framework
fih
ctdna
dose-finding
dose-escalation
bayesian-design
molecular-response
project-optimus
2026年5月02日
ctDNA for Participant Selection and Prognosis in FIH Trials
fih
ctdna
patient-selection
prognosis
maxVAF
biomarker
shared-decision-making
2026年5月02日
Dose Escalation Design Comparison: 3+3, BOIN, CRM, and Beyond
fih
statistics
bayesian
boin
crm
dose-escalation
3plus3
phase-i
2026年5月02日
FDA 2024 Dose Optimization Guidance: Regulatory Language Becomes Requirement
fih
regulatory
fda
dose-optimization
guidance
rp2d
exposure-response
2026年5月02日
FDA-AACR 2025 Dose Optimization Trilogy: Start, Explore, Register
fih
dose-optimization
fda-aacr
registrational-trial
backfill
randomized-expansion
exposure-response
2026年5月02日
FIH Paper Reading Checklist for Clinicians
fih
teaching
journal-club
checklist
dose-optimization
2026年5月02日
FIH Starting Dose: The NOAEL/HNSTD to MABEL/PK-PD Framework
fih
starting-dose
noael
hnstd
mabel
pad
pk-pd
dose-selection
project-optimus
2026年5月02日
FIH Starting Dose Selection: From Safety Floor to Biological Hypothesis
fih
starting-dose
mabel
hnstd
noael
pad
dose-escalation
regulatory
2026年5月02日
Immune-Engager FIH: Building an RP2D Evidence Chain When MTD Is Not Reached
fih
immune-engager
rp2d
receptor-occupancy
pd-biopsy
checkpoint
bispecific
mtd
evidence-chain
project-optimus
2026年5月02日
Patient-Centered Tolerability: Making 'Can the Patient Live on This Dose?' a Measurable Endpoint
fih
tolerability
patient-reported-outcomes
pro
dose-optimization
project-optimus
teaching
2026年5月02日
Project Optimus: From MTD to Dose Optimization
fih
dose-optimization
project-optimus
fda
regulatory
mtr
rp2d
2026年5月02日
Radiopharmaceutical Therapy FIH: Activity, Dosimetry, and Dose Optimization
fih
rpt
radiopharmaceutical
dosimetry
alpha-emitter
lutetium
actinium
absorbed-dose
psma
2026年5月02日
SPIRIT-DEFINE and CONSORT-DEFINE: Raising the Quality Bar for FIH Trial Protocols and Reports
fih
reporting
protocol
quality
define
spirit
consort
teaching
2026年5月02日
Starting Dose Beyond MABEL: Immune-Activating Drugs and Population-Based Modeling
fih
starting-dose
mabel
immunotherapy
t-cell-engager
bispecific
pk-pd-modeling
cytokine-release
sting-agonist
population-modeling
2026年5月02日
SY-5007 RET Inhibitor: A Modern FIH Case Study
fih
ret-inhibitor
case-study
ctdna
biomarker
dose-escalation
dose-expansion
molecular-targeted-therapy
project-optimus
resistance
2026年5月02日
T-cell Engager: Clinical Workflow and Case Studies
fih
t-cell-engager
bispecific
clinical-workflow
alnuctamab
checkpoint-bispecific
subcutaneous-dosing
multiple-myeloma
case-study
2026年5月02日
T-cell Engager FIH: CRS Biology and Step-up Dosing Design
fih
t-cell-engager
bispecific
crs
step-up-dosing
mabel
midd
icans
2026年5月02日
Three Modern FIH Platforms: ADC, T-cell Engager, and Radiopharmaceutical Compared
fih
adc
t-cell-engager
rpt
comparison
dose-optimization
project-optimus
platform-specific
teaching
2026年5月02日
TITE-BOIN: Managing Late-Onset Toxicity and Fast Accrual in Phase I Trials
fih
statistics
bayesian
boin
tite-boin
late-toxicity
accrual
backfill
phase-i
2026年5月02日
HNSCC First-in-Human 試驗全景（AACR 2026）
hnscc
fih
phase1
clinical-trial
aacr-2026
2026年5月02日
HNSCC 試驗設計的缺口：分子創新 vs 設計保守
hnscc
trial-design
fih
adaptive-design
biomarker-selection
hpv-negative
combination-therapy
2026年5月01日
Head and Neck Cancer at AACR 2026
hnscc
adc
bispecific
checkpoint
biomarker
fih