The Ultimate Glossary of Life Science Terms and Acronyms [Over 450 Terms]

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

  1. What does eTMF stand for? Tweet this question
  2. Here's a test: Who know's what a CSR is? Tweet this question
  3. 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.

About the Author: Oliver Pearce

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