製薬医学用語集
- absorption distribution metabolism excretion
- Academic Research Organization
- Academy of Physicians in Clinical Research
- adverse drug reaction
- Adverse Event
- area under the curve
- bioavailability
- Biological medicine, Biologics, Biopharmaceuticals, Biological products
- biomarker
- Bio-Venture、Biotech Venture
- Brand Plan
- Brand Team
- case report form
- Centers for Medicare & Medicaid Services
- Central Monitoring
- certified review board
- clinical research associate
- clinical research coordinator
- Clinical Study
- clinical study report
- Coding
- common technical document
- company core data sheet
- company core safety information
- conflicts of interest management
- Contract Manufacturing Organization
- contract research organization
- biomarker
- data and safety monitoring committee
- Data Management
- data safety monitoring board
- development safety update report
- Diagnosis Procedure Combination
- Digital Therapeutics
- Digital Therapeutics Alliance
- Double Blind
- drug interaction
- Drug lag
- Drug repositioning（DR，Drug Repurposing）
- due diligence
- electronic trial master file
- Eudra Vigilance data analysis system
- European Federation of Pharmaceutical Industries and Associations
- European Medicines Agency
- Exploratory Study
- Fast track
- FDA Adverse Event Reporting System
- first-in-human
- fragment-based drug design
- Generalisability, Generalisation
- Good Clinical Practice
- Good Laboratory Practice
- Good Manufacturing Practice
- Good Vigilance Practice
- Health Economics & Outcomes Research
- Health Technology Assessment
- highest non-severely toxic 1 dose
- incremental cost-effectiveness ratio
- independent data monitoring committee
- individual case safety report
- Informed Consent
- Informed Consent Form
- Institutional Review Board
- Integrity
- interactive voice response system
- interactive web response system
- Intercurrent Event
- Interim Analysis
- International Coalition of Medicines Regulatory Authorities
- International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
- International Conference on Pharmaceutical Medicine
- International Federation of Associations of Pharmaceutical Physicians & Pharmaceutical Medicine
- International Federation of Pharmaceutical Manufacturers & Associations
- Interview Form
- Investigational Medical Product
- investigator brochure
- Japanese Adverse Drug Event Report database
- Japan Pharmaceutical Manufacturers Association
- Japanese Association of Pharmaceutical Medicine
- Kaplen-Meier法
- kinase
- Life Cycle Management
- ligand-based drug design
- master file
- maximum tolerated dose
- Medicaid
- Medical Affairs
- medical information for risk assessment initiative Project
- medical representative
- Medical Science Liaison
- Medicare
- National Institute Health and Care Excellence
- National Institutes of Health
- Orphan Drug
- patent cooperation treaty
- patient reported outcome
- periodic benefit-risk evaluation report
- periodic safety update report
- Pharmaceutical Medicine Specialist Training
- pharmaceutical physician
- pharmaceutical price regulation scheme（PPRS）
- Pharmaceutical Research and Manufacturers of America
- Pharmaceuticals and Medical Devises Agency
- pharmacogenomics
- pharmacological action
- PharmaTrain
- Phase II Study
- Phase III Study
- post marketing surveillance
- power
- Precision Medicine
- proof of concept
- Protocol
- protocol deviation
- Quality of life
- quality-adjusted life year
- Randomized Controlled Study (Trial)
- Real World Data
- risk management plan
- serious adverse event
- Site Management Organization
- Software as a Medical Device
- source data verification
- Standard Operating Procedures
- STD10
- summary of product characteristics
- Superiority Trial
- suspected unexpected serious adverse reaction
- Technology Licensing Organization
- The Council for International Organizations of Medical Sciences
- toxicokinetics
- trial master file
- type I error rate
- Unites States Food and Drug Administration
- vaccine
- World Health Organization
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