Abbreviations and acronyms 

# | a | b| c | d | e | f | g | h | i | j | k | l | m | n | o | p | q | r | s | t | u | v | w | x | y | z

 

#

5-HT Serotonin

5-hydroxytryptamine = serotonin

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A

ACDM = Association for Clinical Data Management

ACE = acetylcholinesterase

ACH = Acetylcholine  

ACS = American Chemical Society

ACTH = Adrenocorticotropic hormone

ADH = Alcohol dehydrogenase

ADH, vasopressin = Antidiuretic hormone

ADME = absorption, distribution, metabolism and excretion 

ADMET = absorption, distribution, metabolism, excretion and toxicity

ADR = adverse drug reaction

AE = adverse event

AEs = adverse events

AIDS = Acquired Immune Deficiency Syndrome

AIG = Active Ingredient Group

ALS = amyotrophic lateral sclerosis

ANDA = Abbreviated New Drug Application

ANOVA = Analysis of variance

AOQL = AVERAGE OUTGOING QUALITY LEVEL

AQL = ACCEPTABLE QUALITY LEVEL

AR = adverse reaction

ASC = Advertising Standards Canada  

ASCII = American Standard Code for Information Interchange

ASQ = American society for quality

ATP = adenosine triphosphate  

ATP = Advanced Technology Program  

ATPE = Aqueous two-phase extraction

AWG = Expert Working Groups   

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B  

BAA = Broad Agency Announcements

BBB = Blood Brain Barrier

BGTD = Biologics and Genetic Therapies Directorate

β-End = β-Endorphin   

BI = biological indicator

BIMO = Bioresearch Monitoring  

BIs = biological indicators

BL1-LS = Biosafety Level 1 large-scale

BLA = Biologics License Application  

BODs = Boards of Directors 

BPR = Batch Production Records

BPRs = Basic Research Plans   

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C

CADRMP = Canadian Adverse Drug Reaction Monitoring Program

CAT = choline acetyltransferase

CBER = Center for Biologics Evaluation and Research

CCS = cell-cycle specific

CDA = clinical data analyses

CDC = clinical data coordinator

CDC Centers for Disease Control

CDER = Center of Drug Evaluation and Research

CDISC = Clinical Data Interchange Standards Consortium

CDM = Clinical Data Management

CDS = clinical data specialist  

CED = Cause-Effect Diagram

CFD = clean file declaration

CFR = Code of Federal Regulations  

cGMP = current Good Manufacturing Process  

CHEM = Labs  chemistry  

CIB = Clinical Investigator's Brochure  

CIS = Clintrial Integration Solution

CL = clinical listing

CMV = Cyto-Megalo Virus

CO = cardiac output

COPD  = Chronic Obstructive Pulmonary Disease   

CONMEDS = Concomitant medications

COSTART = Coding Symbols for a Thesaurus of Adverse Reaction Terms

COX = cyclooxygenase  

CMA = Continuous Market Application

Cp = Process Capability

CPG = consumer packaged goods

CPMP = Committee for Proprietary Medicinal Product

CPR = emergency planning and response           

CRA = clinical research associate

CRC = clinical research coordinator

CRF = case report form

CRO = Contract Research Organization  

CRS = clinical research scientist 

CS = clinical scientist 

CSF = Cerebrospinal Fluid

CSO = Consumer Safety Officer

CT = clinical trail  

CTAB  = cetyltrimethylammonium bromide

CTD = Common Technical Document

CTQ = critical to quality    

CV = curriculum vitae

CVA = Cardiovascular Accident

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D

DA = Dopamine

DBL = data base lock

DBMS = database management system

DCC = data change convention

DCF = data clarification form  

DCI = Data Capture Interface 

DCFs = data clarification forms

DCM = Data collection module

DDAVP® =  desmopressin acetate,  1-deamino-8- d -arginine vasopressin

DEHP = diethylhexylphthalate

DEMO = Demographics and subject characteristics  

DHHS = department of health and human services

DHP = Data Handling Protocol

DIA = Drug Information Association   

DISPOSIT = Disposition

DIN = Drug Identification Number

DIT = diiodotyrosine  

DMARD = disease-modifying antirheumatic drug 

DMAIC = process (define, measure, analyze, improve, control)

DMADV methodology (define, measure, analyze, design, verify) 

DMF = drug master file  

DMID = Division of Microbiology and Infectious Diseases

DMOP = data management operational plan

DOB = date of birth

DOD = date of death

DOPA = 3,4-dihydroxyphenylalanine

DPD = Drug Product Database  

DPMO = Defects per Million Opportunities

DSMB = Data and Safety Monitoring Board

DSMBs = Data and Safety Monitoring Boards 

DVGs = discrete value groups

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E  

ECG = Electrocardiogram

ECF = Extra Cellular Fluid  

e-CRF = Electronic Case Report Form 

ECs = ethics committees

EDC = Electronic Data Capture  

EFPIA = European Federation of Pharmaceutical Industries and Associations 

EFTA = European Free Trade Are a

EFTA = European Free Trade Association

EIR = Establishment Inspection Report

ELISA = enzyme-linked immunosorbent assay

EMEA = European Agency for te Evaluation of Medical Products

EMR = electronic medical record

EPA = Environmental Protection Agency

EPDM = ethylene propylene diene monomer

ERISA = Employee Retirement Income Security Act 1974

ESA = EMISSION SPECTROGRAPHIC ANALYSIS  

EtO = Ethylene oxide

EU = endotoxin units

EWG = Expert Working Group

EXPOSURE = Drug exposure    

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F

FDA = Food and Drug Administration

FDM = Functional Deployment Matrix

FOB = functional observation battery

FOI = Freedom of Information

FOIA = Freedom of Information Act 

FSH = Follicle Stimulating Hormone

FU = fraction unbound  

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G

G6PD = Glucose-6-phosphate dehydrogenase

GABA = Gamma-Aminobutyric acid

GAMP = Good Automated Manufacturing Practice  

GC = gas chromatography

GCP = Good Clinical practice  

GCDMP = Good Clinical Data Management Practice

GDP = Good Distribution Practice

GFR = glomerular filtration rate

GH = Growth Hormone

GHTF = Global Harmonization Task Force

GI = Gastro Intestinal 

GIT = Gastro Intestinal Tract

GLP = Good Laboratory Practices

GMP = good manufacturing practice (cGMP)  

GTP = guanosine triphosphatE

GUI = Graphical User Interface

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H

HDL = high-density lipoproteins +

HEMA = Labs hematology

HHS = Health and Human Services

HIPAA = Health Insurance Portability and Accountability Act 

HIV = human immune-deficiency virus

HIV = Human Immunodeficiency Virus  

HLT = High level term

HLGT = High level group term

HMG-CoA = 3-hydroxy-3-methylglutaryl coenzyme A

HMW = high-molecular-weight 

HPFB = Health Products and Food Branch

HPFBI = Health Products and Food Branch Inspectorate

HPLC = high-pressure liquid chromatography

HTS = high throughput screening  

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I

IACUC = Institutional Animal Care and Use Committee 

IB = Investigator's Brochure   

IBCTs = Internet Based Clinical Trials

IC = Institute and Center

ICD-CM = International Classification of Diseases with Clinical Modification

ICDRA = International Conference of Drug Regulatory Authorities

ICH  = International Conference on Harmonisation

IDDM = Insulin-dependent diabetes mellitus

IDE = independent development evaluation

IDMC = Independent Data-Monitoring Committee

IEC = independent ethics committee 

IFPMA = International Federation of Pharmaceutical Manufacturers Association 

IM = intramuscularly 

IME = important medical event

IMPs = investigative medicinal products

IND = investigational new drug  

IOL = intraocular lens

IOM = Institute of Medicine

IOM = Investigations Operations Manual  

IOP = Interim/Interface Operating Procedure

IP = investigational product  

IPO = initial public offering

IQ = INSTALLATION QUALIFICATION

IQL = INDIFFERENCE QUALITY LEVEL  

IRB = institutional review board 

IRB/IEC = INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE

IRR=internal rate of return  

IRS = Internal Revenue Service  

ISE = Information Systems Engineering 

ISM = Independent Safety Monitor  

ISS = Information System Services

IV = intravenous 

IVD = in vitro diagnostic

IVDs = in vitro diagnostics  

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J

J-ART = Japanese Adverse Reaction Terminology

JD = Doctor of Jurisprudence 

JGA = juxtaglomerular apparatus

JPMA = Japan Pharmaceutical Manufacturers Association  

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K

KPIs = Key Performance Indicators

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L

LAL = limulus amebocyte lysate

LAR - legally authorized representative

LD50 = lethal dose for 50% of test subjects

LDL = low-density lipoproteins

LH = Luteinizing hormone

LLOQ = lower limit of quantification

LLT =  Lowest level term

LMW = low-molecular-weight  

LSL = Lower Spec Limit

LTPD = LOT TOLERANCE PERCENT DEFECTIVE

LVLP = last visit, last patient  

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M  

MAb = monoclonal antibody

MAC = Mycombacterium avium Complex

MAO = monoamine oxidase  

MBI = mercapto-benzimidazole-sulfonic acid

MC = membrane chromatography

MCA = Medicines Control Agency

MCO = managed-care organization

MCOs = managed-care organizations

MedDRA = Medical Dictionary for Regulatory Activities  

MEDHIST = Past medical history  

MEP = mercaptoethyl pyridine

MHLW = Ministry of Health, Labor and Welfare, Japan

MHW = Ministry of Health and Welfare

MI =  Myocardial Infarction

MIT = monoiodotyrosine

MMSE = Mini-Mental State Examination

MRA = mutual recognition agreement

MRSA = Methicillin-Resistant Staphylococcus aureus  

MS = mass spectrometric

MSH = melanocyte stimulating hormone

MSSO = Maintenance and Support Services Organization  

MWCB = MASTER WORKING CELL BANK

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N

NAFTA = North American Free Trade Agreement

NAI = No Action Indicated

NAPA = N-acetylprocainamide

NCCS = non-cell-cycle specific

NCEs = Networks of Centres of Excellence

NCI = National Cancer Institute 

NCR = no carbon required

NDA = New Drug Application

NDS = New Drug Submission  in Canada

NE = Norepinephrine  

NF = National Fonnulary

NHS = Nation Health Service

NIAID = National Institute of Allergy and Infectious Diseases

NIDDM  = Non-insulin-dependent diabetes mellitus

NIEHS = National Institute of Environmental Health Sciences 

NIH = national institute of health 

NIHS = National Institute of Health Sciences (Japan)  

NIST = National Institute of Standards and Technologies

NOC = Notice of Compliance

NOC/c = Notice of Compliance with Conditions

NPH = neutral protamine Hagedorn  

NPV= net present value

NRC = National Research Council

NSABP = National Surgical Adjuvant Breast and Bowel Project (NSABP)

NSAIDs = non-steroidal anti-inflammatory drugs

NTP = National Toxicology Program

NTs = neurotransmitters  

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O  

OAI = Official Action Indicated

OCRA = Office of Clinical Research Affairs

OCTs = Online Clinical Trials 

ODB = Ontario Drug Benefits

ODM = Object Data Manager

OECD = Organization for Economic Cooperation and Development

OPRR = Office for Protection from Research Risks   

OQ = OPERATIONAL QUALIFICATION

ORA = Office of Regulatory Affairs

OTC = over the counter  

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P  

PA = physician assistants

PAAB = Pharmaceutical Advertising Advisory Board

PAGE = poly-acrylamide gel electrophoresis  

PAR = Proven Acceptable Range

PAT = Process Analytical Technology 

PBMS = pharmacy benefits management organizations  

PCs = Personal Computers

PD = Parkinson’s disease HD = Huntington’s disease AD = Alzheimer’s diseaseHSV = Herpes Simplex Virus  

PDC = paper data capture

pdf = Portable Document Format

PDL = POPULATION DOUBLING LEVEL

PE = Physical examination  

PEG = polyethylene glycol

PERT = program evaluation and review technique  

PGP ® =  Pretty Good Privacy®

PhRMA = Pharmaceutical Research and Manufacturers of America  

PI = Principal Investigator

PIDA = Public Interest Disclosure Act 1998  

PLOT = preclinical lead optimisation technologies 

PMA = Pre-Market Approval

PO = Per oral

PO = Project Officer  

Pp = Process Performance

PPD = Purified Protein Derivative 

PLCs = Programmable logic controllers

 PQ = PERFORMANCE QUALIFICATION  

PRDA = Program Research and Development Announcements

PRL = Prolactine

PSA = Public Service Announcement  

PT = Preferred term

PTT = Partial Thromboplastin Time (test)

PUVA = Psoralen Ultra-Violet A

PZI = protamine zinc insulin.

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Q

QAU = quality assurance units  

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R  

RCA = regional clinical associate 

RDE = remote data entry

RN = registered nurse 

ROI= return on investment

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S

SAEs = serious adverse events

SAS = Statistical Analytical System+

SBOA = Summary Basis Of Approval 

SBR = styrene butadiene rubber 

SC = Steering Committee  

SCDM = Society for Clinical Data Management

SDR = Source Document Review  

SDMB = safety data monitoring boards

SDV = source data verification

SIBR = Small Business Innovative Research 

SIC = STANDARD INDUSTRIAL CLASSIFICATION CODE

SIC. =   Spelled incorrectly

SIP = steam-in-place

SIADH = Syndrome of inappropriate Anti-diuretic Hormone

SKAs = skills, knowledge, and abilities

SKK = Seikagaku Corporation  of Tokyo  

SLE  = Systemic Lupus Erythematosus (aka Disseminated Lupus Erythematosus, D  

SLR = spore log reduction

SMC = Safety Monitoring Committe

SMO = site management organization   

SOC = System Organ Class

SPC = Statistical process control

SPOOS = significant payments of other sorts

SQL = structured query language

SVP = small volume parenteral 

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T

TC = total cholesterol  

TCO =  total cost of ownership

TEAVs = Treatment-emergent abnormal values

TEM = Transmission Electron Microscopy

TEM = Triethylenemelamine

TGS = triglycerides

TPD = Therapeutic Products Directorate  

TPR = total peripheral vascular resistance

TRH =  Thyrotropin Releasing Hormone  

TSB = trypticase soy broth

TSH = thyroid stimulating hormone 

TPP = Therapeutic Products Panel 

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U  

UNIX = Universal Network Information Exchange

URINE = Labs urinalysis  

ULOQ = upper limit of quantification

USL = Upper Spec Limit

USP = United States Pharmacopoeia   

UWMC  = University of Washington Medical Center  

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V

VAI = Voluntary Action Indicated

VAMC = Vetrqans affairs Medical Center  

VEBs = ventricular ectopic beats  

VITAL = Vital signs

VLDL = very low-density lipoproteins 

VOC = VOLATILE ORGANIC COMPOUND

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W  

WANs = Wide Area Networks

WBC = white blood cell

WHO-ART = World Health Organization Adverse Reaction Terminology  

WFI = water for injection

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X

 

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Y

 

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Z

  

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Copyright Kriger Research Center Inc. 2003