Termen/ afkortingen

Question 1

1 - Introduction

GLP

Answer 1

Good laboratory practice

Question 2

1 - Introduction

GCP

Answer 2

Good clinical practice

Question 3

1 - Introduction

GMP

Answer 3

Good manufacturing practice

Question 4

1 - Introduction

CTD

Answer 4

European Clinical Trials Directive

Question 5

1 - Introduction

CTR

Answer 5

European Clinical Trials Regulation

Question 6

1 - Introduction

NCE

Answer 6

New Chemical Entity

Question 7

1 - Introduction

NME

Answer 7

New Molecular Entity

Question 8

1 - Introduction

NBE

Answer 8

New Biological Entity

Question 9

2 - Drug discovery

MTX

Answer 9

Methotrexaat

Question 10

3 - Drug discovery

SAR

Answer 10

structure activity relationship

Question 11

4 - Farmaceutical development

PAMPA

Answer 11

parallel artificial membrane permeability assay

Question 12

4 - Pharmaceutical development

API

Answer 12

Active pharmaceutical ingredient

Drug = API + excipients

Question 13

4 - Pharmaceutical development

HTS

Answer 13

High throughput screening

Question 14

4 - Pharmaceutical development

BCS

Answer 14

Biofarmaceutisch classificatiesysteem

Question 15

4 - Pharmaceutical development

FaSSIF

Answer 15

Fasted state stimulated intestinal fluid

Question 16

4 - Pharmaceutical development

FeSSIF

Answer 16

Fed state stimulated intestinal fluid

Question 17

4 - Pharmaceutical development

HPMC

Answer 17

Hydroxypropylmethylcellulose

Question 18

4 - Pharmaceutical development

PF

Answer 18

Polariteit factor

Question 19

4 - Pharmaceutical development

IV

Answer 19

Intraveneus

Question 20

4 - Pharmaceutical development

IM

Answer 20

Intramusculair

Question 21

4 - Pharmaceutical development

SC

Answer 21

Subcutaan

Question 22

4 - Pharmaceutical development

TTS

Answer 22

Transdermaal therapeutisch systeem

Question 23

4 - Pharmaceutical development

MEC

Answer 23

Minimale effectieve concentratie

Question 24

4 - Pharmaceutical development

IUD

Answer 24

Intra uterine device

Question 25

# 4 - Pharmaceutical development IA

Answer 25

Intra-arteriaal of intra-articulair

Question 26

# 4 - Pharmaceutical development IT

Answer 26

Intrathecal

Question 27

# 4 - Pharmaceutical development IC

Answer 27

Intracardiaal

Question 28

# 4 - Pharmaceutical development MPS

Answer 28

Mononuclear fagocyt systeem

Question 29

# 4 - Pharmaceutical development EPR

Answer 29

Enhanced permeability and retention

Question 30

# 4 - Pharmaceutical development MLV

Answer 30

Multilamellar vesicles

Question 31

# 4 - Pharmaceutical development SUV

Answer 31

Small unilamellar vesicles

Question 32

# 4 - Pharmaceutical development LUV

Answer 32

Large unilamellar vesicles

Question 33

# 5 - Clinical drug development IB

Answer 33

Investigator's brochure

Question 34

# 5 - Clinical drug development IND

Answer 34

Investigational New Drug application | Gelijkaardig aan CTA, clinical trial application (EU)

Question 35

# 5 - Clinical drug development DART

Answer 35

Developmental and reproductive toxicity

Question 36

# 5 - Clinical drug developmental NOEL

Answer 36

No Observed Effect Level

Question 37

# 5 - Clinical drug development NOAEL

Answer 37

No Observed Adverse Effect Level

Question 38

# 5 - Clinical drug development MRSD

Answer 38

Maximal Recommended Starting Dose

Question 39

# 5 - Clinical drug development HED

Answer 39

Human equivalent dose

Question 40

# 5 - Clinical drug development MABEL

Answer 40

Minimal anticipated biological effect level

Question 41

# 5 - Clinical drug development PAD

Answer 41

Pharmaceutical active dosis

Question 42

# 5 - Clinical drug development PBPK

Answer 42

Physiology based pharmacokinetics

Question 43

# 5 - Clinical drug development FIH

Answer 43

First in human

Question 44

# 5 - Clinical drug development FIM

Answer 44

First in man

Question 45

# 5 - Clinical drug development MTD

Answer 45

Maximale tolereerbare dosis

Question 46

# 5 - Clinical drug development ATD

Answer 46

Anticipated therapeutic dose

Question 47

# 5 - Clinical drug development SAD

Answer 47

Single ascending dose

Question 48

# 5 - Clinical drug development MAD

Answer 48

Multiple ascending dose

Question 49

# 5 - Clinical drug development AUC

Answer 49

Area under the curve

Question 50

# 6 - Clinical drug development PoP

Answer 50

Proof of Principle

Question 51

# 6 - Clinical drug development PoC

Answer 51

Proof of Concept

Question 52

# 6 - Clinical drug development ADA

Answer 52

Anti drug antibodies

Question 53

# 7 - Clinical drug development NDA

Answer 53

New Drug Application

Question 54

# 7 - Clinical drug development IMP

Answer 54

Investigational medical products

Question 55

# 7 - Clinical drug development RCT

Answer 55

Randomized controlled trial

Question 56

# 7 - Clincal drug development SoC

Answer 56

Standard of Care

Question 57

# 7 - Clinical drug development IVRS

Answer 57

Interactive Voice Response System | Computerized ranomization

Question 58

# 7 - Clinical drug development MA

Answer 58

Market Authorisation

Question 59

# 8 - Clinical drug development eCTA

Answer 59

Exploratory clinical trial application | Microdosing or phase 0

Question 60

# 8 - Clinical drug development eIND

Answer 60

Exploratory investigational new drug | In de US de term voor eCTA

Question 61

# 8 - Clinical drug development PET

Answer 61

Positron emission tomography

Question 62

# 8 - Clincial drug development AMS

Answer 62

Accelerator mass spectrometry