In today's ever-changing business environment we see more and more terms, acronyms and phrases being used than we have ever done before, and unfortunately the life science industry is no different. With the emergence of new technology and new therapeutics, attempting to put a name on things in pharma can become quite the exercise.
With this in mind, we thought it might be helpful to put together a one size fits all glossary of life science terms, terminology, acronyms, abbreviations or however you like to call them! Some of which you may know, and some you just might discover for the first time. We scoured the internet, books and people to come up with something comprehensive. You will find over 450 terms to make name-dropping a 3-to-5 word phrase in a board meeting or networking event a breeze.
I hope that you will pass this blog post along to others in your organization and maybe even print it out to have on hand when others have questions about the many terms used in the Life Sciences.
So here goes...
A
AAAS American Association for the Advancement of Science
AABB American Association of Blood Banks
AADA Abbreviated Antibiotic Drug Application (FDA) (used primarily for generics)
AAMC Association of American Medical Colleges
AAPP American Academy of Pharmaceutical Physicians
AAPS American Association of Pharmaceutical Scientists
ABPI Association of the British Pharmaceutical Industry
ACCP American College of Clinical Pharmacology
ACE adverse clinical event
ACIL a national trade association representing independent, commercial scientific, and engineering firms (formerly the American Council of Independent Laboratories)
ACP renamed ACRP in 1997
ACPU Association of Clinical Pharmacology Units
ACRA Associate Commissioner for Regulatory Affairs (FDA)
ACRP Association of Clinical Research Professionals, formerly Associates in Clinical Pharmacology (ACP)
ACRPI now the Institute of Clinical Research (UK)
ACT Applied Clinical Trials magazine
ACTG AIDS Clinical Trials Group (NIAID)
ACTU AIDS Clinical Trials Unit (NIH)
AD antidepressant; Alzheimer’s disease
ADAMHA Alcohol, Drug Abuse, and Mental Health Administration (no longer exists)
ADAS Alzheimer’s Disease Assessment Scale
ADAS COG Alzheimer’s Disease Assessment Scale, Cognitive Subscale
ADE adverse drug event; adverse drug effect
ADME absorption, distribution, metabolism, and excretion (used to describe pharmacokinetic processes)
ADR adverse drug reaction
AE adverse event; adverse experience
AEGIS ADROIT Electronically Generated Information Service
AERS Adverse Event Reporting System (FDA)
AFCR See AFMR
AFMR American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)
AHA Area Health Authority (UK)
AHCPR Agency for Health Care Policy Research (NIH)
AICRC Association of Independent Clinical Research Contractors (UK)
AMC academic medical center
AMA American Medical Association
AmFAR American Foundation for AIDS Research
AMG Arzneimittelgesetz (German Drug Law)
AMI acute myocardial infarction
ANDA Abbreviated New Drug Application (for a generic drug)
ANOVA analysis of variance (statistics)
AOAC Association of Official Analytical Chemists
APB Association Pharmaceutique Belge (Belgium)
APhA American Pharmaceutical Association
API active pharmaceutical ingredient
ARDS adult respiratory distress syndrome
ARENA Applied Research Ethics National Association
ARO academic research organization
ASAP administrative systems automation project (FDA)
ASCII American Standard Code for Information Interchange (computer files)
ASCPT American Society for Clinical Pharmacology and Therapeutics
ASQ American Society for Quality, formerly American Society for Quality Control
AUC area under the curve (statistics)
AZT zidovudine (HIV treatment)
B
BARQA British Association of Research Quality Assurance
BCE beneficial clinical event
BDPA Bureau of Drug Policy and Administration (China)
BEUC European Bureau of Consumer Unions
BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)
BGA Bundesgesundheitsamt (Federal health office; former German public health agency)
BGVV Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany)
BIO Biotechnology Industry Organization
BIRA British Institute of Regulatory Affairs
BLA Biologics License Application (FDA)
BPAD bipolar affective disorder
BPI Bundesverband der Pharmazeutischen Industrie EV (Germany)
BrAPP British Association of Pharmaceutical Physicians
BSA body surface area
C
CA Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations)
CAD coronary artery disease
CAPRA Canadian Association of Pharmaceutical Regulatory Affairs
CAS Chemical Abstracts Service
CBCTN Community Based Clinical Trials Network
CBER Center for Biologics Evaluation and Research (FDA)
CCI Committee on Clinical Investigations. See also CCPPRB, CHR, CPHS, CRB, EAB, EC, HEX, IEC, IRB, LREC, MREC, NIRB, REB
CCPPRB Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also CCI, CHR, CPHS, CRB, EAB, EC, HEX, IEC, IRB, LREC, MREC, NIRB, REB
CCRA Certified Clinical Research Associate. ACRP certification of monitors.
CCRP Certified Clinical Research Professional. SOCRA certification of coordinators, monitors, and other research professionals.
CCRC Certified Clinical Research Coordinator. Certification issued to clinical coordinators by ACRP.
CDC Centers for Disease Control and Prevention (Atlanta, GA)
CDER Center for Drug Evaluation and Research (FDA)
CDISC Clinical Data Interchange Standards Consortium (formerly the Clinical Data Interchange Standards Committee, a DIA committee)
CDM clinical data management
CDRH Center for Devices and Radiological Health (FDA)
CEN Comité Européen de Normalisation (European Committee for Standardization)
CEU continuing education unit
CF consent form
CFR Code of Federal Regulations (usually cited by title and part, for example, Title 21, Part 211 is shown as 21 CFR 211)
cGMP current good manufacturing practices
CHR committee on human research. See also CCI, CCPPRB, CPHS, CRB, EAB, EC, HEX, IEC, IRB, LREC, MREC, NIRB, REB
CIOMS Council for International Organisations of Medical Sciences (postapproval international ADR reporting, UK)
CIP Certified IRB Professional
CIS Commonwealth of Independent States
CLIA Clinical Laboratory Improvements Amendments
Cmax concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug
CMC chemistry, manufacturing, and control
CME continuing medical education
CMS Centers for Medicare and Medicaid Services
CNS central nervous system
COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA
CPHS committee for the protection of human subjects
CPMP Committee for Proprietary Medicinal Products (EU)
CPSC Consumer Product Safety Commission (U.S.)
CRA clinical research associate. See also CCRA
CRADA cooperative research and development agreement (with NIH)
CRB case record book
CRB central review board
CRC clinical research coordinator. See also CCRC, SC, SSC
CRF case report form (sometimes case record form)
CRO contract research organization. See also IPRO
CSDD Center for the Study of Drug Development
CSM Committee on Safety of Medicines (UK)
CSO Consumer Safety Officer (FDA)
CSR clinical study report
CSU clinical supply unit
CT clinical trial
CTC clinical trial certificate (UK)
CTEP Clinical Therapeutics Evaluation Program (NCI)
CTM clinical trials materials
CTX clinical trial exemption (MCA)
cv curriculum vitae
CVM Center for Veterinary Medicine (FDA)
D
DAWN Drug Abuse Warning Network
DD Department of Drugs (Swedish regulatory agency)
DEA Drug Enforcement Administration (U.S.)
DEN Drug Experience Network
DES Data Encryption Standard
DESI Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962)
DGD Now OGD (formerly CBER’s Division of Generic Drugs)
DGPharMed Deutsche Gesell-schaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly FÄPI
DHEW Department of Health, Education and Welfare (U.S., now split into DHHS and Department of Education)
DHHS Department of Health and Human Services (U.S.)
DHTML dynamic HTML (IT)
DIA Drug Information Association
DoD Department of Defense (U.S.)
DPC-PTR Act Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman-Hatch or Hatch-Waxman bill)
DRG Division of Research Grants (NIH); Diagnosis Related Groups
DSI Division of Scientific Investigations (FDA)
DSM Diagnostic and Statistical Manual (of the American Psychiatric Association)
DSMB Data and Safety Monitoring Board
DSNP development of standardized nomenclature project (FDA)
DTC direct-to-consumer (drug advertising)
DTD document type definition (for electronic interchange)
E
EAB advisory board. See also CCI, CCPPRB, CHR, CPHS, CRB, EC, HEX, IEC, IRB, LREC, MREC, NIRB, REB
EAB Editorial Advisory Board (Applied Clinical Trials)
EC ethics committee. See also CCI, CCPPRB, CHR, CPHS, CRB, EAB, HEX, IEC, IRB, LREC, MREC, NIRB, REB
EC European Commission (in documents older than the mid-1980s, EC may mean European Community)
ECJ European Court of Justice
ECOG Eastern Cooperative Oncology Group (U.S.)
ECPHIN European Community Pharmaceutical Products Information Network
ECU European Currency Unit
EDC electronic data capture
EDI electronic data interchange
EDMS electronic document management system
EEC European Economic Community, now EU; some regulatory documents still have EEC document numbers
EFGCP European Forum for Good Clinical Practice
EFPIA European Federation of Pharmaceutical Industries and Associations
EFTA European Free Trade Association
EIR Establishment Inspection Report (FDA)
ELA Establishment License Application (FDA)
EMEA European Agency for the Evaluation of Medicinal Products
EMS electronic mail service
EORTC European Organization for the Research and Treatment of Cancer
EP European Parliament
EPAR European Public Assessment Report
EPO European Patent Office
EPRG European Pharmacovigilance Research Group
ER Essential Requirements (EMEA)
ESRA European Society of Regulatory Affairs
ESTRI Electronic Standards for the Transfer of Regulatory Information (M2)
eTMF electronic trial master file
EU European Union
EUDRA European Union Drug Regulatory Authorities
EWG expert working group
F
FAQ frequently asked questions (IT)
Farmindustria The Association of Italian Pharmaceutical Manufacturers
FD&C Act Food, Drug, and Cosmetic Act (U.S.)
FDA Food and Drug Administration (U.S.)
FDAMA FDA Modernization Act
FDLI Food and Drug Law Institute
FFPM Fellow of the Faculty of Pharmaceutical Medicine (UK)
FRCP Fellow of the Royal College of Physicians, sometimes followed by a place name–for example, FRCP (Edin.)–that indicates a university medical school
FTC Federal Trade Commission (U.S.)
FTP File Transfer Protocol
FWA federal-wide assurance
G
GAO General Accounting Office (U.S. government)
GBP good business practice
Gbps gigabits or billions of bits per second (data transmission)
GCP good clinical practice
GCRP good clinical research practice
GLP good laboratory practice
GMP good manufacturing practices
GP general practitioner; general practice (UK)
GPMS good post-marketing surveillance practice (Japan)
GRAS generally regarded as safe (foods)
GXP Good X Practice (FDA compliance; X can mean: Clinical, Laboratory, Manufacturing, Pharmaceutical, etc.)
H
HARTS Hoechst Adverse Reaction Terminology System
HCFA Health Care Financing Administration (HHS)
HEX human experimentation committee
HHS Department of Health and Human Services (U.S., also called DHHS)
HIMA Health Industry Manufacturers Association
HL7 Health Level 7 (clinical data interchange)
HPB Health Protection Branch, Laboratory Centre for Disease Control (Canada)
HPLC high performance liquid chromatography
HSRC human subjects review committee
HTML Hypertext Markup Language (IT)
HTTP hypertext transfer protocol (IT)
I
IB investigator’s brochure
IC informed consent
ICD9 International Classification of Diseases, 9th revision. See also MedDRA
ICF informed consent form
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICR Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK)
ICSR individual case safety report
ICS report integrated
ICTH International Committee on Thrombosis and Haemostases
IDDM insulin-dependent diabetes mellitus
IEC independent ethics committee
IEEE The Institute of Electrical and Electronic Engineers, Inc.
IFAPP International Federation of Associations of Pharmaceutical Physicians
IFPMA International Federation of Pharmaceutical Manufacturers’ Associations
IG Inspector General (HHS)
IKS Interkantonale Kontrollstelle für Heilmittel (Switzerland)
IMP investigational materials plan
IND Investigational New Drug application (FDA). See also TIND
IOM Institute of Medicine (National Academy of Science, U.S.)
IPRO independent pharmaceutical research organization. See also CRO
IRB institutional review board; independent review board. See also CCI, CCPPRB, CHR, CPHS, CRB, EAB, EC, HEX, IEC, LREC, MREC, NIRB, REB
IRD International Registration Document
ISCB International Society for Clinical Biostatistics
ISDN Integrated Services Digital Network
ISO International Organization for Standardization
ISP Internet service provider
IT information technology
ITU-T Telecommunication Standardization Sector of the International Telecommunications Union
IVD in vitro device; in vitro diagnostics
IVF in vitro fertilization
IVF/ET in vitro fertilization/ embryo transfer
IVR interactive voice response (telephone technology)
J
JCAHO Joint Commission on Accreditation of Healthcare Organizations
JCPT Journal of Clinical Pharmacology and Therapeutics
JCRDD Journal of Clinical Research and Drug Development
JCRP Journal of Clinical Research and Pharmacoepidemiology
JMA Japan Medical Association
JPMA Japan Pharmaceutical Manufacturers Association
K
Kbps thousands of bits per second (data transmission)
KS Kaposi’s sarcoma
L
LAN local area network (IT)
LIF Swedish Pharmaceutical Industry Association
LKP Leiter der klinischen Prüfung, under the German Drug Law, the physician who is head of clinical testing
LOA letter of agreement
LREC local research ethics committee(UK). See also CCI, CCPPRB, CHR, CPHS, CRB, EAB, EC, HEX, IEC, IRB, MREC, NIRB, REB
MA marketing authorization
M
Mbps millions of bits per second (data transmission)
MCA Medicines Control Agency (UK)
MDR Medical Device Reporting
MECU million ECU
MEDDRA Medical Dictionary for Drug Regulatory Affairs
MedDRA Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART,
ICD9, and others)
MEDLARS Medical Literature Analysis and Retrieval System
MEFA Association of the Danish Pharmaceutical Industry
MEP Member of the European Parliament
MHW Ministry of Health and Welfare (Koseisho, Japan’s drug regulatory agency)
MOH Ministry of Health (UK, Canada, others)
MOPH Ministry of Public Health
MOU memorandum of understanding (an MOU between FDA and a regulatory agency in another country allows mutual recognition of inspections)
MR medical representative (Japan)
MRA medical research associate
MREC multicentre research ethics committee(UK). See also CCI, CCPPRB, CHR, CPHS, CRB, EAB, EC, HEX, IEC, IRB, LREC, NRB, REB
MRI magnetic resonance imaging
MTD maximum tolerated dose
MVP master validation plan
N
NABR National Association for Biomedical Research
NAF Notice of Adverse Findings (FDA post-audit letter)
NAI No Action Indicated (most favorable FDA post-inspection classification)
NAS new active substance (UK)
NAS—NRC National Academy of Sciences—National Research Council (U.S.)
NBAC National Bioethics Advisory Commission (U.S.)
NCCAM National Center for Complementary and Alternative Medicine, formerly Office of Alternative Medicine (NIH)
NCCTG North Central Cancer Treatment Group (U.S.)
NCE new chemical entity
NCHGR National Center for Human Genome Research (NIH)
NCHS National Center for Health Statistics (in CDC)
NCI National Cancer Institute (NIH)
NCPIE National Council on Patient Information and Education (Washington, DC)
NCR no carbon [paper] required
NCRR National Center for Research Resources (NIH)
NCVIA National Childhood Vaccine Injury Act (1986)
NDA New Drug Application (FDA)
NDS New Drug Study (Canada’s new drug application)
NEFARMA Dutch Association of the Innovative Pharmaceutical Industry
NEI National Eye Institute (NIH)
NGO nongovernmental organization
NHI National Health Insurance (Japan)
NHLBI National Heart, Lung and Blood Institute (NIH)
NHS National Health Service (UK)
NIA National Institute on Aging (NIH)
NIAAA National Institute on Alcohol Abuse and Alcoholism (NIH)
NIAID National Institute of Allergies and Infectious Diseases (NIH)
NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)
NICHD National Institute of Child Health and Human Development (NIH)
NIDA National Institute on Drug Abuse (NIH)
NIDCD National Institute on Deafness and Other Communication Disorders (NIH)
NIDDK National Institute of Diabetes and Digestive and Kidney Diseases (NIH)
NIDR National Institute of Dental Research (NIH)
NIEHS National Institute of Environmental Health Sciences (NIH)
NIGMS National Institute of General Medical Sciences (NIH)
NIH National Institutes of Health (DHHS)
NIMH National Institute of Mental Health (NIH)
NINDS National Institute of Neurological Disorders & Stroke (NIH)
NINR National Institute of Nursing Research (NIH)
NIRB non-institutional review board
NLM National Library of Medicine (NIH)
NME new molecular entity
NRB non-institutional review board, also known as an independent review board. See also CCI, CCPPRB, CHR, CPHS, CRB, EAB, EC, HEX, IEC, IRB, LREC, MREC, REB
NSCLC non—small cell lung carcinoma
NTP National Toxicology Program
O
OAI Official Action Indicated (serious FDA post-inspection classification)
OAM See NCCAM
ODAC The Oncologic Drugs Advisory Committee (U.S.)
ODE Office of Drug Evaluation (CDER now has five such offices: ODE I, II, III, IV, and V)
OGD Office of Generic Drugs (CDER, formerly DGB)
OGE Office of Government Ethics (formerly part of Office of Personnel Management, separate executive branch in 1989)
OHRP Office for Human Research Protections
OIG Office of the Inspector General
OJC Office Journal of the European Union—C Series (Information)
OJL Office Journal of the European Union—L Series (Legislation)
OMB Office of Management and Budget (U.S.)
OPRR Office for Protection from Research Risks (predecessor to OHRP)
OSHA Occupational Safety Health Administration (U.S.)
OTA Office of Technology Assessment (U.S.; abolished by Congress, fall 1995)
OTC over-the-counter (refers to nonprescription drugs)
P
PAB Pharmaceutical Affairs Bureau (Japan)
PAHO Pan American Health Organization
PCC Poison Control Center
PCP Pneumocystis carinii pneumonia
PD pharmacodynamics
PDA personal digital assistant (Palm Pilot, for example)
PDF Portable Document Format
PDQ Physicians’ Data Query (NCI-sponsored cancer trial registry)
PDR Physicians’ Desk Reference
PDUFA Prescription Drug User Fee Act (1992, U.S.)
PEM prescription event monitoring
PERI Pharmaceutical Education & Research Institute (not-for-profit division of PhRMA)
PFT pulmonary function tests
PhRMA Pharmaceutical Research and Manufacturers of America (formerly PMA)
PHS Public Health Service (U.S.)
PI principal investigator
PK pharmacokinetics
PKI public key infrastructure (IT)
PLA Product License Application (FDA)
PMA Pre-Market Approval application (FDA)
PMS post-marketing surveillance
PPI patient package insert
PPO preferred provider organization; policy and procedure order
PR public relations
PRIM&R Public Responsibility in Medicine and Research (Boston, MA)
PROG peer-review oversight group (NIH)
PSUR periodic safety update report
PTC Points to Consider
Q
QA quality assurance
QbD Quality by Design
QAU quality assurance unit
QC quality control
QL quality of life
QOL quality of life
R
R&D research and development
R&TD research and technological development
RADAR Risk Assessment of Drugs–Analysis and Response
RAPS Regulatory Affairs Professionals Society
RCT randomized clinical trial
RDE remote data entry
RDRC Radioactive Drug Research Committee
REB research ethics board (Canada). See also CCI, CCPPRB, CHR, CPPHS, CRB, EAB, EC, HEX, IEC, IRB, LREC, MREC, NRB
RKI Robert-Koch-Institut, Bundesinstitut für Infektionskrankheiten und nich-übertragbare Krankheiten (Federal Institute for Infectious and Non-communicable Diseases, Germany)
RL regulatory letter (FDA post-audit letter)
S
SAE serious adverse event
SAS Statistical Analysis System (commonly used statistical analysis package)
SATCM State Administration of Traditional Chinese Medicine (China)
SBA summary basis of approval
SC study coordinator. See also CRC, CCRC, SSC
SCT Society for Clinical Trials
SD standard deviation
SDA State Drug Administration (China)
SDAT Senile Dementia of the Alzheimer’s Type
SE standard error (statistics)
SEA Single European Act of 1987
SEER Surveillance, Epidemiology, and End Results (Registry of NCI)
SGML Standard Generalized Markup Language (IT)
SLA service level agreement
SMART Submission Management and Review Tracking (FDA)
SME significant medical event
SMO site management organization
SmPC Summary of Product Characteristics
SNDA Supplemental New Drug Application
SNIP Syndicat National de l’Industrie Pharmaceutique (France)
SNOMED Systematized Nomenclature of Medicine (a dictionary)
SOCRA Society of Clinical Research Associates
SOP standard operating procedure
SPAC State Pharmaceutical Administration of China
SPM Society of Pharmaceutical Medicine (UK)
SQA Society of Quality Assurance
SQAP systems quality assurance plan
SSC study site coordinator. See also CRC, CCRC, SC
SSCT Swedish Society for Clinical Trials
SSFA Società di Scienze Farmacologiche Applicate (Italy)
SSM skin surface microscopy
STD sexually transmitted disease
STT short term tests
SUD sudden unexpected death
SWOG Southwest Oncology Group (U.S.)
T
TB tuberculosis
TCP/IP Transmission Control Protocol/Internet Protocol
TESS treatment emergent signs and symptoms
TIND Treatment IND. See also IND
TK toxicokinetics
tmax the time after dosing when Cmax occurs
TMO trial management organization
U
UK United Kingdom
URL uniform resource locator (address of a Web site)
USC United States Code (book of laws)
USDA Department of Agriculture (U.S.)
USP United States Pharmacopeia
V
VA Veterans Administration (officially, United States Department of Veterans Affairs)
VAERS Vaccine Adverse Event Reporting System
VAI Voluntary Action Indicated (FDA post-audit inspection classification)
VPN virtual private network
W
WAN wide area network
WHO World Health Organization
WHOART World Health Organization Adverse Reaction Terminology
WL Warning Letter (most serious FDA post-audit letter, demands immediate action within 15 days)
WRAIR Walter Reed Army Institute of Research (DoD)
WTO World Trade Organization
www World Wide Web
X
XML Extensible Markup Language (IT)
Test your colleagues and friends
- What does eTMF stand for? Tweet this question
- Here's a test: Who know's what a CSR is? Tweet this question
- EMEA - What does it stand for? Tweet this question
Are there any that we missed? Leave a comment below so we can add them to the list.
