Glossary
ABC-ATP-binding
ABC transporters (ATP binding cassette) form a large family of membrane proteins that share an ATP-binding cassette as a common structural element
ADA
Anti-Drug Antibodies
ADC
Antibody Drug Conjugate
ADD
Acceptable Daily Dose
ADE
Adverse Drug Event
ADME
absorption, distribution, metabolism and excretion
ADR
Adverse Drug Reaction
AE
Adverse Event
AESGP
Association of the European Self-Medication Industry
OEL
Occupational exposure limit
AHU
Air handling unit
ALARP
As Low As Resonable Practicable
AMC
Airborne Molecular Contamination
AMG
German Drug Law
AMG-AV
German Drug Law Notification Regulation
AMG-EV
German Drug Law Regulation on the submission of documents
AMIS
German Drug Information System
AMTS
Drug Therapy Safety
AMVV
German Regulation on the prescription of medicinal products
ANOVA
Analysis of Variance
AP
American Patent
AP
Aqua Purificata
APA
Aseptic Processing Area
APR
Annual Product Review
ASR
Annual Safety Report
AT
Advanced Therapies
ATD
Anti-Tampering-Device
BBB (Artificial)
(Artificial) Brain Blood Barier
Caco2 Permeation
colon epithelial cancer cell line Permeation (Carcinoma colon)
CCIT
Container Closure Integrity Testing
cIEF
Capillary isoelectric focusing
CLIA
Chemiluminescence Immunoassays
CSF
colony-stimulating factor
CYPs (Human)
Cytochromes P450 (CYP) are heme proteins with enzymatic activity (oxidoreductases)
DBS
Dried Blood Spots
DIO
deiodinase types I, II, or III (DIO1, DIO2 or DIO3, respectively)
DER
Drug Extract Ratio
DGGF
German Society for Good Research Practice
DIA
Drug Information Association
DICI
Drug-Induced-Cholestasis-Index
DIMDI
German Institute for Medical Documentation and Information
DIO
Diet-induced obesity
DIP
Desinfection in Place
DMF
Drug Master File
DMPK
Drug metabolism and pharmacokinetics
DMPQ
Division of Manufacturing and Product Quality
DNEL
Derived No-Effect Level
DoE
Design of Experiments
DPhG
German Pharmaceutical Society
DSP
downstream processes
E&L
Extractables and Leachables
EC 50
Effective Concentration 50 %
ECLIA
Electrochemiluminescence Assays
EGFR
Epidermal Growth Factor Receptor
ELV
Exposure Limit Value
EPO
Erythropoeitin
FEFO
First expired - First out
G-CSF
Human granulocyte colony-stimulating factor
GDP
Good Distribution Practices
GSH
Glutathione
GSP
Good Storage Practice
GSSH
GSSG + 2 e + 2 H+ -> 2 GSH: -240 mV
GST
Glutathione S-transferase
HAPI
Highly Active Pharmaceutical Ingredient
HAS
Highly Active Substances
HCP
Host cell proteins
HPAPI
Highly Potent Active Pharmaceutical Ingredient
i.a.
intra-arterial
i.c.
intracutaneous
i.m.
intramuscular
i.v.
intravenous
ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
IRMA
Immuno radiometric assays
IVD
In-vitro Diagnostic
IVIVC
In-vitro- / In-vivo-Correlation
KBT
Preservative load test
KKS
Coordination center for clinical studies
KP
Clinical pharmacy
KP
Clinical trial
LA
lack of approval
LADME
Liberation, absorption or reabsorption, distribution, metabolism and excretion.
LAL
Limulus amebocyte lysate test
LBDD
Ligand Based Drug Design
LDH
Lactate dehydrogenase
LIA
Luminescence immunoassay
LKP
Head of the clinical trial
LOAEL
Lowest Observed Adverse Effect Level
LOEL
Lowest Observed Effect Level
MA
Marketing Authorization
MAA
Application to a Marketing Authorization
mAB
monoclonal antibody
MACO
Maximal Allowable Carry Over
MAO
Monoamine oxidase
MCB
Master Cell Bank
MCH
Mean corpuscular hemoglobin
MCHC
Mean corpuscular hemoglobin concentration
MDCK
Madin Darby Canine Kidney
MDO
Multi Dose (Container)
MED
Minimum Effect Dose
MKT
Mean kinetic temperature
MPPS
Most Penetrating Particle Size
MTG
Human Animal Genetic engineering
MVD
Maximum Valid Dilution
NAP
National Authorised Product
nc
not compliant
NDD
Nutrient-defined diet
NIS
sodium-iodide symporter
NIS
Non-interventional study
NOAEL
No Observed Adverse Effect Level
NOC
No Objection Certificate
OGW
Upper limit
OOSRR
Out of Specification Result Report
OOT
Out of Trend
OOX
Out of X
OSD
Oral Solid Dosage Form
PAD
Pharmacologically Active Dose
PAES
Post Authorisation Efficacy Studies
PAMPA
Parallel Artificial Membrane Permeability Assay
PAR
Proven Acceptable Range
PD
Pharmacodynamics
PDE
Permitted Daily Exposure
PET
Positron Emission Tomography
PgP-Interaction
P-glycoprotein interaction
PK
Pharmacokinetics
PPB
Plasma protein binding
PPB
Parts per billion
PPN
Pharmacy Product Number
PQS
Pharmaceutical Quality System (PQS from ICH Q 10. From 2013 Chapter 1 of the EU GMP Guide Part I)
PRGF
Platelet-Rich Growth Factor
PTG
Pharmataxigraphy
PTM
Post-translational modifications
PUPSIT
Pre-Use Post-Sterilization Integrity Testing
RAIU
Radioactive iodide uptake
RCA
Root Cause Analysis
RCT
Randomised Clinical Trial
RDI
Relative dose intensity
RED
Rapid Equilibrium Dialyse
rFC
recombinant factor C
RIA
Radioimmunoassay
RR
Cleanroom
RRLC
Rapid Resolution Liquid Chromatography
s.c.
subcutaneous
S9-Fraction
Liver tissue-derived enzyme-containing preparation for metbolic activation of test substances in bacterial test systems
SAE
Serious Adverse Event
SAL
Sterility Assurance Level
SHT
Steril Hold Time
SLC-Transporter
Solute carrier, is a collective term for about 52 families of human transport proteins (called carriers or membrane proteins)
SoHO
Substances of Human Origin
SPB
Supplementary protection certificates
STZ
Streptozotocin-induced diabetes
TDI
Total Daily Intake
TFF
Tangential Flow Filtration
THG
Tetrahydrogestinone
THMP
Traditional Herbal Medicinal Products
TIC
Total inorganic carbon
TPO
thyroid peroxidase
TTC
Threshold of Toxicological Concern
TTSPP
Time- and temperaturesensitive pharmaceutical products
USP
upstream processes
USP
United States Pharmacopeia