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Pharmaceutical medicine > Termen/ afkortingen > Flashcards

Termen/ afkortingen Flashcards

1
Q

1 - Introduction

GLP

A

Good laboratory practice

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2
Q

1 - Introduction

GCP

A

Good clinical practice

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3
Q

1 - Introduction

GMP

A

Good manufacturing practice

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4
Q

1 - Introduction

CTD

A

European Clinical Trials Directive

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5
Q

1 - Introduction

CTR

A

European Clinical Trials Regulation

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6
Q

1 - Introduction

NCE

A

New Chemical Entity

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7
Q

1 - Introduction

NME

A

New Molecular Entity

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8
Q

1 - Introduction

NBE

A

New Biological Entity

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9
Q

2 - Drug discovery

MTX

A

Methotrexaat

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10
Q

3 - Drug discovery

SAR

A

structure activity relationship

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11
Q

4 - Farmaceutical development

PAMPA

A

parallel artificial membrane permeability assay

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12
Q

4 - Pharmaceutical development

API

A

Active pharmaceutical ingredient

Drug = API + excipients

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13
Q

4 - Pharmaceutical development

HTS

A

High throughput screening

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14
Q

4 - Pharmaceutical development

BCS

A

Biofarmaceutisch classificatiesysteem

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15
Q

4 - Pharmaceutical development

FaSSIF

A

Fasted state stimulated intestinal fluid

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16
Q

4 - Pharmaceutical development

FeSSIF

A

Fed state stimulated intestinal fluid

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17
Q

4 - Pharmaceutical development

HPMC

A

Hydroxypropylmethylcellulose

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18
Q

4 - Pharmaceutical development

PF

A

Polariteit factor

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19
Q

4 - Pharmaceutical development

IV

A

Intraveneus

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20
Q

4 - Pharmaceutical development

IM

A

Intramusculair

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21
Q

4 - Pharmaceutical development

SC

A

Subcutaan

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22
Q

4 - Pharmaceutical development

TTS

A

Transdermaal therapeutisch systeem

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23
Q

4 - Pharmaceutical development

MEC

A

Minimale effectieve concentratie

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24
Q

4 - Pharmaceutical development

IUD

A

Intra uterine device

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25
Q

4 - Pharmaceutical development

IA

A

Intra-arteriaal of intra-articulair

26
Q

4 - Pharmaceutical development

IT

A

Intrathecal

27
Q

4 - Pharmaceutical development

IC

A

Intracardiaal

28
Q

4 - Pharmaceutical development

MPS

A

Mononuclear fagocyt systeem

29
Q

4 - Pharmaceutical development

EPR

A

Enhanced permeability and retention

30
Q

4 - Pharmaceutical development

MLV

A

Multilamellar vesicles

31
Q

4 - Pharmaceutical development

SUV

A

Small unilamellar vesicles

32
Q

4 - Pharmaceutical development

LUV

A

Large unilamellar vesicles

33
Q

5 - Clinical drug development

IB

A

Investigator’s brochure

34
Q

5 - Clinical drug development

IND

A

Investigational New Drug application

Gelijkaardig aan CTA, clinical trial application (EU)

35
Q

5 - Clinical drug development

DART

A

Developmental and reproductive toxicity

36
Q

5 - Clinical drug developmental

NOEL

A

No Observed Effect Level

37
Q

5 - Clinical drug development

NOAEL

A

No Observed Adverse Effect Level

38
Q

5 - Clinical drug development

MRSD

A

Maximal Recommended Starting Dose

39
Q

5 - Clinical drug development

HED

A

Human equivalent dose

40
Q

5 - Clinical drug development

MABEL

A

Minimal anticipated biological effect level

41
Q

5 - Clinical drug development

PAD

A

Pharmaceutical active dosis

42
Q

5 - Clinical drug development

PBPK

A

Physiology based pharmacokinetics

43
Q

5 - Clinical drug development

FIH

A

First in human

44
Q

5 - Clinical drug development

FIM

A

First in man

45
Q

5 - Clinical drug development

MTD

A

Maximale tolereerbare dosis

46
Q

5 - Clinical drug development

ATD

A

Anticipated therapeutic dose

47
Q

5 - Clinical drug development

SAD

A

Single ascending dose

48
Q

5 - Clinical drug development

MAD

A

Multiple ascending dose

49
Q

5 - Clinical drug development

AUC

A

Area under the curve

50
Q

6 - Clinical drug development

PoP

A

Proof of Principle

51
Q

6 - Clinical drug development

PoC

A

Proof of Concept

52
Q

6 - Clinical drug development

ADA

A

Anti drug antibodies

53
Q

7 - Clinical drug development

NDA

A

New Drug Application

54
Q

7 - Clinical drug development

IMP

A

Investigational medical products

55
Q

7 - Clinical drug development

RCT

A

Randomized controlled trial

56
Q

7 - Clincal drug development

SoC

A

Standard of Care

57
Q

7 - Clinical drug development

IVRS

A

Interactive Voice Response System

Computerized ranomization

58
Q

7 - Clinical drug development

MA

A

Market Authorisation

59
Q

8 - Clinical drug development

eCTA

A

Exploratory clinical trial application

Microdosing or phase 0

60
Q

8 - Clinical drug development

eIND

A

Exploratory investigational new drug

In de US de term voor eCTA

61
Q

8 - Clinical drug development

PET

A

Positron emission tomography

62
Q

8 - Clincial drug development

AMS

A

Accelerator mass spectrometry

Pharmaceutical medicine (1 decks)

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