Saturday, April 09, 2005

This material has been published by the International Biopharmaceutical Association . Please note this material does not give any medical advice.

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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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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
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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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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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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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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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
EtO = Ethylene oxide
EU = endotoxin units
EWG = Expert Working Group
EXPOSURE = Drug exposure
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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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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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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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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
IRB = institutional review board
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-ART = Japanese Adverse Reaction Terminology
JD = Doctor of Jurisprudence
JGA = juxtaglomerular apparatus
JPMA = Japan Pharmaceutical Manufacturers Association
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KPIs = Key Performance Indicators
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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
LVLP = last visit, last patient
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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
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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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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
ORA = Office of Regulatory Affairs
OTC = over the counter
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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
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
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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QAU = quality assurance units
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RCA = regional clinical associate
RDE = remote data entry
RN = registered nurse
ROI= return on investment
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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. = 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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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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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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VAI = Voluntary Action Indicated
VAMC = Vetrqans affairs Medical Center
VEBs = ventricular ectopic beats
VITAL = Vital signs
VLDL = very low-density lipoproteins
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WANs = Wide Area Networks
WBC = white blood cell
WHO-ART = World Health Organization Adverse Reaction Terminology
WFI = water for injection
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Copyright Kriger Research Center Inc. 2005

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