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医薬品・医療機器開発用語集

A

ABAbortion
Abbreviated NDA
Abdominal pain
ACabdominal circumference
Accidental Symptom
ACEAdverse Clinical Event
Acne
ADAlzheimer’s Disease
ADAtopic Dermatitis
ADEAdverse Drug Event
ADLActivities of Daily Living
ADME Absorption, Distribution, Metabolism, and Excretion
(used to describe pharmacokinetic processes)
Administration
ADRAdverse Drug Reaction
AEAdverse Event, Adverse Experience
AEDAntiepileptic Drug
AESGPEuropean Proprietary Medicines Manufacturers Association
AfAtrial fibrillation
AGAngiography
AHCPRAgency for Health Care Policy &Research
AIDSAcquired immune deficiency syndrome
ALCOAAttributable,Legible,Contemporaneous,Original,Accurate
ALCOA(CCEA)(Complete,Consistent,Enduring,Available when needed)
Algorithm
Alternative hypothesis
AMAAmerican Medical Association
AMEDJapan Agency for Medical Research and Development
Amendment
Amendment (to the protocol)
AMGArzneimittelgesetz
AMIAcute Myocardial Infarction
ANDAAbbreviated New Drug Application
Anemia
Anorexia
ANOVAAnalysis of Variance
Antibody Drug
APAngina Pectoris
APhAAmerican Pharmaceutical Association
ApoApoplexy
AppAppendicitis
Applicable Regulatory Requirement(s)
Approval
Approval
ARCAIDS-Related Complex
ARDSAdult Respiratory Distress Syndrome
ARFAcute Renal Failure
Arthritis
ASCOAmerican Society of Clinical Oncology
ASCPTAmerican Society for Clinical Pharmacology and Therapeutics
ASQCAmerican Society for Quality Control
Asthma
AUCArea Under the blood concentration time Curve
Audit Certificate
Audit Report
Audit Trail
Authorized Representative

B

BABioavailability
BABronchial Asthma
BEBioequivalence
Bias
BIOBiotechnology Industry Association
Bioavailability
Bioinformatics
Biostatistics
Bleeding
Blind Study
Blinding / Masking
Blood Concentration
BPblood pressure
Breast Cancer
Bridging Study
BSBlood sugar
BW/Wtbody weight

C

CACompetent Authority
CaCarcinoma
CADCoronary artery disease
Cancer
CANDAComputer-Assisted NDA
CAPACorrective Action and Preventive Action
Carcinogenicity
Cardiology
Carry-over effect
CASChemical Abstracts Service
Case-control Study
CatCataract
CBChronic bronchitis
CBERCenter for Biologics Evaluation and Research
CBFCerebral Blood Flow
CCCommon cold
CDCCenter for Disease Control and Prevention
CDERCenter for Drug Evaluation and Research
CDISCClinical Data Interchange Standards Consortium
CDLClinical Data Liaison
CDRHCenter for Devices and Radiological Health
CE Marking
Cervical Cancer
CFRCode of Federal Regulations
CHDCoronary Heart Disease
Chest pain
Chronic Disease
CICerebral Infarction
CIOMSCouncil for International Organizations of Medical Sciences
Clinical Significance
Clinical Study (Trial) Report
Clinical Trial Registry
CmaxMaximum Drug Concentration
CMCChemistry, Manufacturing, and Control
CMOContract Manufacturing Organization
CNSCentral Nervous System
Co-medical
Cohort Study
Colorectal Cancer
Combined / Combination Therapy
Comparative Study
Comparator (Product)
Compensation
Competent Authorities
Complete Clinical Data Package
Compliance (in relation to trials)
Concomitant Drug / Medication
Confidentiality
Confidentiality
Confirmatory trial
Constipation
Content Validity
Contract
Control group
Controlled Study
Coordinating Committee
Coordinating Investigator
Cough
CPACyclophosphamide
CRAClinical Research Associate
CRCClinical Research Coordinator
CRFCase Report Form
CROContract Research Organization
Crossover Trials
CSDDCenter for the Study of Drug Development
CSOContract Sales Organization
CSOContract Service Organization
CTClinical Trial
CTCAECommon Terminology Criteria for Adverse Events
CTDCommon Technical Document
CTNClinical Trial plan Notification
Custom-made Medicine
cv.Curriculum Vitae
CVMCenter for Veterinary Medicine
Cytokine
Cytomegalovirus infections

D

Data Acquisition
Data Validation
DBDatabase(s)
DBTDouble Blind Test
DDSDrug Delivery System
DEADrug Enforcement Association
Declaration of Helsinki
Degradation Product
Depression
Depressive type
Dermatology
DHHSU.S. Department of Health and Human Services
DIADrug Information Association
Dialysis
Diarrhea
DIBDDevelopment International Birth Day
Dietary Supplement
Direct Access
Dissolution Test
Distribution volume
Dizziness
DLTDose Limiting Toxicity
DMDiabetes mellitus
DMData Management
DMFDrug Master File
Documentation
Dosage
Dosage form
Dose
Dose Finding Study
Dose interval
Dose regimen
Dose response
Dose-response curve
Double-blind Study
Double-dummy
DRGDiagnosis Related Groups
Dropout
Drug Design
Drug Development
Drug history / Drug profile
DSMCData and Safety Monitoring Committee
DSURDevelopment Safety Update Report
Duration of dosing
Dyslipidemia
Dyspepsia
Dysuria

E

EABEthical Advisory Board
EBMEvidence- Based Medicine
ECEthical Committee
ECGElectrocardiography
eCTDElectronic Common Technical Document
EDErectile Dysfunction
EDCElectronic Data Capture
Edema
Efficacy
EFGCPEuropean Forum on Good Clinical Practice
EFPIAEuropean Federation of Pharmaceutical Industries
EIREstablishment Inspection Report
EMEAEuropean Medicines Evaluations Agency
Emphysema
Endocrinology
Endpoint
EPIEpidemiology
Epidemiological Study
Epidemiological Survey
Epidemiology
Epigastric distress
EPOEuropean Patent Office
Equivalence Study
ESembryo stem cell
Essential Documents
Ethnic Differences
EUEU directives
EurdaCTEuropean Clinical Trials Database
Exanthema
Exclusion criteria
Exploratory trial
Extrinsic Ethnic Factors

F

Factorial Study Design
FASFull Analysis Set
Fatigue
FBSFasting Blood sugar
FDAFood and Drug Administration
FDLIFood and Drug Law Institute
Fever
First-in-man (human) study
First-in-man (human) study
First-line drug
First-pass effect
Follicular Lymphoma
FTCFederal Trade Commission
FxFracture

G

G-CSFGranulocyte Colony Stimulating Factor
Gastric Cancer
GCPGood Clinical Practice
Gene Therapy
Generic drugs
Genome Medicine
Genotoxicity (mutagenicity)
GIGastrointestinal
Glioblastoma multiforme
Glioma
GLPGood Laboratory Practice
GMPGood Manufacturing Practice
GPGeneral Practitioner
GPSPGood Post-marketing Study Practice
GQPGood Quality Practice
GSGallstone
GUGastric ulcer
GVPGood Vigilance Practice
Gynaecology

H

HCFAHealth Care Financing Administration
Head and Neck Cancer
Headache
Healthy Volunteer
Heart Failure
Hematemesis
Hematologic Neoplasms
Hematuria
Hemoptysis
HENHome Enteral Nutrition
Hepatic Impairment
Hepatitis A
HIDAHealth Industry Distributor Association
HIVHuman Immunodeficiency Virus
HIV infections
HRHeart Rate
HtHeight
Human Subject
Hyperlipemia
Hyperlipidemia
Hypotension

I

IBInvestigator’s Brochure
IBDInternational Birth Day
ICInformed Consent
ICCIn-Country Caretaker
ICHInternational Conference on Harmonization
ICHIntracerebral hemorrhage
Idiopathic
IDMCIndependent Data Monitoring Committee
IECIndependent Ethics Committee
Immunology
IMPInvestigational (Medicinal) Product
Impartial Witness
IMPDInvestigational Medicinal Product Dossier
Impurity
Inclusion criteria
INDInvestigational New Drug
Indication
Influenza
Inspection
Institution (medical)
Insurance
Interim Analysis
Interim Clinical Trial / Study Report
Intervention Study
Intrinsic Ethnic Factor
Investigational Product
Investigator
IPInterstitial Pneumonia
iPSinduced Pluripotent Stem cells
IRBIndependent / Institutional Review Board
Ischuria
ISOInternational Standards Organization
Itch
ITTIntention to treat
IVDIn Vitro Device, In Vitro Diagnostics
IVFIn Vitro Fertilization
IVHIntravenous Hyperalimentation

J

JCAHJoint Commission for the Accreditation of Hospitals
JCAHOJoint Commission for the Accreditation of Health Care Organizations
JCROAJapan Contract Research Organization Association
JPMAJapan Pharmaceutical Manufacturers Association

K

Kaplan-Meier method
Kidney Transplantation
KSKaposi’s Sarcoma

L

Laboratory
LDLethal dose
Legally Acceptable Representative
Life threatening
Lifestyle drug
Liver Cancer
Liver Transplantation
LLLymphocytic Leukemia
LNLupus Nephritis
Lymphoma
Lymphoma, B-Cell

M

Mantle Cell Lymphoma
MDMedical Doctor
MDDMedical Device Directives
MDVMedical Device Vigilance
Mechanism of Action
MedDRAMedical Dictionary for Drug Regulatory Affairs
MedDRAMedical Dictionary for Rerulatory Activities
Medical Conditions
Medical Economics
Medical Writing
Megatrials
Meta-analysis
Metabolism
Metastatic brain tumor
Metastatic cancer
MGMyasthenia Gravis
MHLWMinistry of Health, Labour and Welfare
Microdose Study
MLMyelogenous Leukemia
MMMalignant Melanoma
MMMultiple Myeloma
Monitor
Monitoring
Monitoring Report
MOUMemorandum of Understanding
MRIMagnetic Resonance Imaging
MRTMean Residence Time
MSMember States
MSMultiple Sclerosis
MTDMaximum Tolerated Dose
Multicenter Study/Trial
Multinational Study/Trial
Multiple Dose

N

NASNational Academy of Sciences
Nasopharyngeal Cancer
Nausea
NCENew Chemical Entity
NCHSNational Center for Health Statistics
NCINational Cancer Institute
NDANew Drug Application
NDANondisclosure Agreement
Neoplasm
Neoplasm Metastasis
Nephrology
Nervous
Neurology
NIHNational Institute of Health
NMNuclear Medicine
NMENew Molecular Entity
Non-blind Study Study
Non-Hodgkin’s Lymphoma
Non-Inferiority Trial
Nonclinical Study
Noncompliance
NSAIDNonsteroidal anti-inflammatory drug
NSCLCNon-Small Cell Lung Cancer
NTPNational Toxicology Program
Nucleic acid
Null hypothesis
Nuremberg Code

O

OAIOfficial Action Indicated
Obesity
Off-label use
Oncology
Open Study
Open-label study
Ophthalmology
Opinion (in relation to Independent Ethics Committee)
Original Medical Record
Orphan Drug
OSHAOccupational Safety Health Administration
Osteoporosis
OTCOver-the-counter
Outsourcing
Ovarian Cancer

P

P/PRpulse rate
Package (Pack) Insert
Pain
Palpitation
Pancreatic Cancer
Patent Term
Patient Advocate
Patient File
Patient’s Right
PDPharmacodynamics
Pediatric
Peripheral Arterial Disease
Personal Physician
Personalized Medicine
PETPosition Emission Tomography
PETPositron Emission Tomography
PGxPharmacogenomix
Pharmaceutical Industry
Pharmacoeconomics
Pharmacogenetics
Pharmacology
Pharmacovigilance
Phase I unit / facility
Phase IIa (study / trial)
Phase IIb (study / trial)
PhRMAPharmaceutical Research and Manufacturers of America
PHSPublic Health Service
Physician
PIPrincipal Investigator
PKPharmacokinetics
Placebo
PLMProduct Life cycle Management
PMDAPharmaceuticals and Medical Devices Agency
PMSPostmarketing Surveillance
PnPneumonia
Pneumonia
PnxPneumothorax
POCProof-of-Concept
Pollaki(s)uria
Post-Approval
Post-Menopausal Osteopenia
Post-Menopausal Osteoporosis
Post-Operative Nausea and Vomiting
PPOPreferred Provider Organization
PPSPer Protocol Set
Preclinical Studies
Preferred vendor / CRO
Process Patent
Prodrug
Prospective Cohort Study
Prostate Cancer
Protocol
Protocol Amendment
Psoriasis
PSURPeriodic Safety Update Report
PSURPeriodic Safety Update Report
Purpura
PVPemphigus Vulgaris

Q

QAQuality Assurance
QCQuality Control
QMSQuality Management System
QOLQuality of Life
Qualified Person
Qualitative variable
Quantitative variable
Quasi drug

R

R&DResearch and Development
RARheumatoid arthritis
Random sampling
Randomization
RAPSRegulatory Affairs Professionals Society
Raw data
RBMRisk Based Monitoring
RCTRandomized Controlled Trial
RDRheumatic disease
RDRecommended Dose
RDERemote Data Entry
Record access
Recruitment (subjects)
Recruitment period
Regimen
Regulatory Affairs
Regulatory Authorities
Renal Cell Cancer
Renal Impairment
Repeated Dose
Reproductive health
Reproductive toxicity
Resuscitation
Retrospective study
RFRenal Failure
Rhinorrhea
Risk-Benefit Analysis
Route of Administration
RR(ORR)Response Rate (Overall Response Rate)

S

SAESerious Adverse Event
Safety
Sarcoma
SBASummary Basis of Approval
SBRSummary Basis of Re-examination
SBTSingle Blind Test
SCStudy Coordinator
Schizophrenia
SCTSociety for Clinical Trials
SDStandard Deviation
SDVSource Data Verification
SEStandard Error
Selection bias
Serious ADRSerious Adverse Drug Reaction
SFDAState Food and Drug Administration
Shortness of breath
Simple Randomization
Single Blind Study
Single Dose
Single Dose Toxicity Study
Site selection
Site visit
Sleeplessness
SMOSite Management Organization
SNPsSingle Nucleotide Polymorphisms
Soft Tissue Infections
SOPStandard Operating Procedure
Sore throat
Source Data
Source Documents
Sponsor
Sponsor-Investigator
Sputum
Ststool
Standardization
Statistical Significance
Statistics Analysis
STDSexually Transmitted Disease
Study Nurse
Subinvestigator
Subject
Subject Identification Code
Substance Patent
SUDSudden Unexpected Death
Surrogate Endpoint
Surrogate Measure
Surrogate Variable
SUSARsSuspected Unexpected Serious Adverse Reactions
Swelling
Syncope

T

Tachycardia
Tailor-made Medicine
TBTuberculosis
TDMTherapeutic Drug Monitoring
Tenderness
Therapeutic
Therapeutic agent
Therapeutic Dose Range
Thirst
Thrombocytopenic Purpura
TKToxicokinetics
Toxicogenomics
Toxicology
TPMTotal Parenteral Nutrition
Transplantation
Tremor
Trial Coordinator
Trial Design
Trial Site
Triple-blind study

U

Ulcer
UMNUnmet Medical Needs
Unexpected Adverse Drug Reaction
Ururine
Urinary Tract Cancer
USUltrasonography
USPUnited States Pharmacopoeia
USPUnited States Patent
USPTOUnited States Patent and Trademark Office
UTIUrinary Tract Infection

V

Vaccination
Vaccine
Validity check
Verify
Volunteer (for clinical trials)
Vomiting
Vulnerable Subjects

W

Wash out period
Well-being (of the trial subjects)
WHOWorld Health Organization
Withdrawal of subjects

NEWS

NEWS GROUP

Future Opportunity Resource

〒111-0032
東京都台東区浅草1-39-11
デンボービル5F
TEL 03-5806-9776
FAX 03-3843-8188

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