The GBA Group Glossary
List of abbreviations

The GBA Group Glossary

Glossary

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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

DEIO

Deiodinase (types I, II and III)

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 activity

TTC

Threshold of Toxicological Concern

TTSPP

Time- and temperaturesensitive pharmaceutical products

USP

upstream processes

USP

United States Pharmacopeia

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