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pharmaceutical medicine > bit of everything > Flashcards

bit of everything Flashcards

1
Q

PoP

A

Proof of Principle

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2
Q

PoC

A

Proof of Concept

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3
Q

PoP/PoC

A

study i wich we go for a new target; new kind of approach; try to show that hitting that target results in the resolution of the problem and the efficacy you are looking for

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4
Q

Therapeutic gain

A

difference between percentage of people free of pain with the drug and with placebo (30% is typical for placebo)

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5
Q

RoI

A

return on investment

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6
Q

NDA

A

New drug application

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7
Q

RCT

A

radomized controlled trial

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8
Q

SoC

A

Standard of Care

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9
Q

IVRS

A

Interactive voice response system

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10
Q

eCTA

A

exploratory Clinical Trial Application

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11
Q

RCT

A

randomized control trial

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12
Q

QSP

A

Quantitative System Pharmacology

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13
Q

IND

A

Investigational new drug

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14
Q

NDA

A

nw drug application

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15
Q

BLA

A

biologics licence application

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16
Q

GCP

A

good clinical practice

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17
Q

GMP

A

good manufacturing practice

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18
Q

NITAG

A

National immunization technnical advisory group

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19
Q

Adverse event

A

Any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment

eg. Headache, acute myocardial infarction, arthritis,…

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20
Q

adverse reaction

A

A response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function

blooc clot after vaccine

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21
Q

Serious adverse event, SAE

A

= any untoward medical occurrence that at any dose: so it is considered serious if the outcome are:
results in death,
is life-threatening,
requires hospitalisation or prolongation of existing hospitalisation,
results in persistent or significant disability or incapacity, or
is a congenital anomaly or birth defect.

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22
Q

Unexpected adverse reaction

A

an adverse reaction, the nature or severity of which is not consistent with the information on the experiment, and, when a clinical trial is concerned, with the applicable product information
(e.g. investigator’s brochure for an unauthorised investigational product or the patient leaflet joined to the summary of product characteristics for an authorised product)

eg. Stomach ache following pain killers

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23
Q

Suspected unexpected serious adverse reaction, SUSAR

A

A serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information

Eg. psychosis/delirium in anti-epileptic medication

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24
Q

Clinical event of interest

A

= very specific adverse reactions that can be expected within a clinical trial and can be serious

Eg. thrombolytics → bleeding
Eg. Drug-Induced Liver Injury (DILI)
Eg. Vaccines  potential immune-mediated disorders

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25
Q

pharmacolvigilance is

A

all processes concerning vigilance and evaluation of side effects (ADR) of the drug for FAMPH

since and activities concerning the follow-up, evaluation, understanding, and prevalence of side effects of other drug-related problem, ADE occurring with a drug WHO

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26
Q

causality assesment

A

evaluation of the likelihood that a particular treatment is the cause of an observed adverse event and is essential to be done and reported to the sponsor, regulatory agencies and safety monitoring committees.

two important questions

usually multi causal complex interaction environment drug patient

9 stuff help

time
pharmacological prop
known assoc
underlying di
concomitant med
dechallenge
rechallenge
dose effect
localisation fo the AR

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27
Q

MRP

A

mutual recognised procedure

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28
Q

SAWP

A

scientific advice working party

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29
Q

MAA

A

Marketing authorisation application

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30
Q

CHMP

A

Committee for Medicinal Products for Human Use

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31
Q

CMA

A

conditional marketing authorisation

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32
Q

CRA

A

clinical research associate

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33
Q

INN

A

international nonproprietary name

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34
Q

CCM

A

cold chain management
guaranteeing the adequate storage of drugs even if they are kept at special temperatures to ain’t an efficient use
alarm

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35
Q

RECIP-E

A

paperless prescribing tools that allow patient to get presecribed medicinal product at the pharmacy by giving their national ID card.

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36
Q

CPOE

A

computerized physician order entry system

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37
Q

CRM

A

commission for reimbursement of medicine

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38
Q

MIDD

A

model informed drug development

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39
Q

RACE

A

rapid assesment of compound exposure

give a single dose of interest to animals orally and parenterally

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40
Q

PAMPA

A

parallel artificial membrane permeation assay

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41
Q

reservoir system

A

enteral controlled released system

API is in the core and is coated with a polymer coating (insoluble, slow release, pH dependent table etc. Once swallowed, water and gastric fluid start to penetrate through the coating, the API get dissolved and diffuse through the coating through the dosage form

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42
Q

matric system

A

enteral controllled release
they are either hydrophilic - polymer in which the API is embedded and start to dissolve very slowly. The gel gets dissolved in the function of the time size of the dosage form

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43
Q

buccal tablet

A

they work based on the adhesion to the mouth via cross-linked polyacrylic acid. the tablet stick to the mounts and with water the material start to form a gel and the API is slowly released in the mount. VEry efficient

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43
Q

suspension what is needed to keep nit in suspension

A

it need wetting agents such as surfactant to ensure contact between liquid and solid phase and visocisty increasing agent to prevent and reduce seimentation as well as pay attention to the size of the particle of the API

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44
Q

cream and ointment difference

A

ointment does not contain water, only the API some lipid and the surfactant

cream need an emulsifier to keep the water in

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45
Q

TTS

A

transdermal therapeutic systems

stick to you skin and the API get delivered through the ski at constant rate

it is done through a rate controlling polymeric (itself regulate and act as a controlling device) membrane at the bottom and underneat an adbhesive layer. at the top there is athe reservoir with a suspension that dispense the API

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46
Q

microparticle based on biodegradable system

A

can be given SC or IM - those polymer degrade very shwoly with the API degradation over a few week

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47
Q

there are microcrystal of poorly soluble drug

A

you can make an ester of these APIs to make the solubility even lower and put it into an injectable system that will dissolve at a steady rate in the muscle over a period of three months

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48
Q

passive targeting for nanosized drug delivery systems

A

mononuclear phagocyte system
local physiological conditions
enhanced permeability and retention effect EPR

49
Q

mononuclear phagocyte system

A

MPS

iv injection, the particulates are cleared by the macrophage from liver and spleen. Once there is macrophage uptake, the drug carrier will be transported to the lysosome and the drug is released upon the breakdown of the carrier

ex are treatment of macrophage intracellular microbial

50
Q

local physiological conditions

A

facilitate the release of the active drug from its carrier system at the specific site using the local pH or presence of a specific enzyme within a target organ

ex is increase alkaline phosphatase increase at tumour level site

51
Q

enhanced permeability and retention EPR effect

A

integrity of the endothelial barier at the site of inflammation or tumours is often disrupted by the presence of endothelial fenestration that can be quite large

macromolecular compounds such as albumin and other polymer-conjugated drugs beyond certain sizes (above 40 kDa) can progressively accumulate in the tumor vascularized area

52
Q

active targeting

A

is when you use targeting groups to bind to specific receptor

targeting via folate receptor
antibodies
lectin-glycoprotein targeting

53
Q

targeting via folate receptor

A

these receptor are upregulate in many human cancer and high density of these receptor appears to increase as the stage of cancer progresses

54
Q

antibodies

A

as drug to target a range of cells
they can be use to conjugate a drug or carrier system and target specific location

55
Q

lectin-glycoprotein targeting

A

can be used to target invading pathogens as lecting are overexperessed on the surface of many tumour cells

56
Q

nanosized drug delivery

A

soluble system include monoclonal antibodies and polymeric carrier (eg xyotax, treatment of non-small cell lung cancer and ovarian)

particulate systems (the drug is physically or chemically associated to the carrier, they have a high drug loading and protected against degradation include liposomes (mRNA), polymeric micelles (both passive via EPR and active eg folate), dendrimers and polymeric nanoparticles

requirement for a good efficient drug-targeting system

no non-specific interaction
no toxicity
retaining the drug during the trans to the target
bust be able to access and be retained at the target
drug must be delivered from its delivery system

57
Q

DSMB role

A

ensure that the decision is very clear upfront and everything is well decided, and safe.

independent and not blinded

ensure that everything is conducted according to the preset standard.

asses the adverse event provided by the investigator

58
Q

EVMPD

A

EudraVigilance Medicinal Product Dictionary: Central European database, registration of product, documenting ADR and evaluation of clinical relevance of ADR

59
Q

ASR

A

Annual Safety Report: a list of all SAE and an evaluation on the safety of the participant

60
Q

HCP

A

healthcare professional

61
Q

MAH

A

market authorisation holders

62
Q

RMP

A

risk management plan

63
Q

PASS

A

post authorisation safety study

64
Q

PIMS

A

Pharmaceutical Information Management System

65
Q

FAMHP

A

The FAMHP plays an essential role in the protection of public health with the following mission:

“Ensuring, from development to use, the quality, safety and efficacy of human and veterinary health product

a public institution under the control of the Minister of Social Affairs and Public Health, is the Belgian national competent and control authority for the regulation of medicinal products and medical devices.

The FAMHP supervises the quality, safety and efficacy of medicines for human or animal use and also has responsibilities for medical devices and blood, tissues and cells. It is also responsible for the EU procedures under the decentralised procedure, the mutual recognition procedure and referrals, and for participation in the centralised procedure.

act as the rapporteur co rapporteur for new MA to theEMA

66
Q

conditional marketing authorisation

A

CMA

you get this for meds that have less comprehensive data still but that touls immediately benefit society and the benefit outweigh the risks

all the requirement should be met

positive benefit risk analysis
comprehensive data will be provided
ubnmet medical needs
benefit immediately

67
Q

CSR

A

clinical study report

68
Q

PRIME

A

scheme for priority medicine under development not yet authorised in the EU

it is done to dvp support for the dvp of medicine that target an unmet medical need
based on interaction and early dialogue with the company to optimise the development of these medicines. OI also give early and proactive support and help to improve clinical trial design

it really ims to stimulate research by providing incentive

69
Q

RMP

A

risk management plan it is part of the pharmacovigilance activities that is designed to identify, characterise, prevent an minimise risk relating to medicinal product such as the effectiveness of the interventions, risk reduction approach etc

70
Q

what does the HTA involve

A

Therapeutic value - aded value of the (efficacy effectiveness etc

price and level of reimbursement

importance in clinical practice

budgetary impact (ability to pay)
ratio cost/ therapeutic value(willingness to pay)

71
Q

HTA

A

multidisciplinary process that uses explicit methods to determine the value of the health technology at different point in its lice cycle

the purpose to inform decision making in order to promote an equitable efficient and high quality health system

72
Q

MEA

A

managed entry agreement

it is between the manufacturer and payer that will enable early access to HT which is still associated with significatn uncertainties (clinical or budgetary)

73
Q

CRM

A

commission for reimubrsement medicine

74
Q

IHSI

A

international horizon scanning initiative

it scans the future tendencies to inform on budgetary and health care budget management

it informs decision-makers on emerging new pharmaceuticals for reimbursement decisions and policy development on issues that are relevant

it allows a better player file with the pharmaceutical industry

potential early dialogue

75
Q

Beneluxa initative

A

it is done to ensure sustainable access to drug and have a bigger ôwer in front of the company

1) information exchange
2IHSI
3) HTA
4) Pricing and reimbursement including joint negotiations

76
Q

in case of succesfull joint assesment and negotiation

A

a decision on reimbursement is made simultaneously but separately in the participating countries

THIS REQUIRES A JOINT HTA

77
Q

LASA

A

look alike and soud alike

78
Q

PIL

A

patient information leaflet

79
Q

PARIS

A

prescription and authorisation requesting information system

80
Q

P&T

A

Pharmacy and therapeutic commitee

81
Q

selection criteria

A

have to be filled by the company

82
Q

award criteria

A

have to be filled by the product

83
Q

BCFI

A

Belgian centre for pharmacotherapie information

84
Q

CU

A

compassionate use

85
Q

innovative period

A

include non clinical part but also clinical part, basically investing money and this is until you get EMA approval

86
Q

monopoly period

A

aproval and comericalisation until the end of the exclusivity

you get the ROI
it depends on the price setting and the length of the period

87
Q

competitive

A

happend afer the LOE and this decline is determine by police makers such as reimbursement policy or substation policy

the need to prove similarity etc

88
Q

biosimilar

A

A biological medicinal product, or biological, is a medicinal product whose active substance is made by a living organism.

A biosimilar is a biological medicinal product that contains a version of the active substance of an original biological medicinal product (reference medicinal product) already authorised in the European Economic Area

89
Q

class 1

A

Class 1: medicinal products with a significant therapeutic improvement compared with existing alternatives.

90
Q

IEC

A

independent ethic comitee

91
Q

PASS

A

post authorisation safety study

92
Q

PIP

A

pediatric investigation plan

protocol containing all the key elements
which are needed to describe the future pediatric programme of a compound aiming for a MA. If they develop such a PIP they get an extension of the patent for 6 months, so when they perform the studies in an early phase also in children.

93
Q

API

A

active pharmaceutical ingredient

94
Q

PSUR

A

periodic safety update report

95
Q

MBDD

A

model based drug development

96
Q

MIDD

A

model informed drug development

umbrella term for Both separate and integrated application of QSP, PBPK, Empirical & semi- mechanistic PK & PK/PD, dose/exposure-response and disease progression
approaches.

they try to maximise and connect the information gathered to fit the purpose such as population extrapolation or clinical trial design etc

it is based on learning confirming cycle

Model-Informed Drug Development (MIDD), sometimes referred to as Model-Based Drug Development (MBDD), is a process whereby key program decisions are supported by mathematical models and simulations that predict the likelihood of success for the drug.

By using mathematical and statistical methods, one is able to build models of drug concentrations (pharmacokinetic) and/or drug responses (pharmacodynamic) over a time course.

Such models allow one to understand how various dosing choices (e.g., dose amount, frequency, and duration) can affect drug concentrations while also demonstrating the relationship between drug concentration and the desired or undesired pharmacodynamic responses.

In addition, these models help to characterize the PK/PD variability of drugs and assist in understanding the clinically relevant factors contributing to variability.

97
Q

MID3

A

model informed drug discovery and devlopment

98
Q

Face validitiy

A

quality aspect refering to the degree of similarity between what the model appears to show or measure and what it claims to show

99
Q

predictive validity

A

qulity aspect refering the the ability to correctly@ identify the efficacy and safety of a putative therapeutic

100
Q

construct validity

A

quality aspect referring to the degree of similarity between the mechanism underlying the pathophysiology present in the model and the human situation

101
Q

bindinding assay

A

relates to the affinity of a compound for a R

102
Q

thermodynamic solubility

A

highest concentraiton o the solute which is in equilibrium with the most table solid form of the solute

103
Q

kinetic solubility

A

dissolve the compound in a organic solvent, add drop in water until there is a precipitate and no longue possible to dissolve

104
Q

dissolution rate

A

the rate at which a compound dissolv very important for the bioavailability
can use FASSIF or fessif

medium will depends on the purpose

105
Q

FASSIF

A

fasting state stimultation intestinal fluid

106
Q

ionisation behaviour

A

determine the pKa pKb via various technique such as potentiometric titration

knowing this allows you to change the pH a bit to increase solubility

for example you can transform in into a salt

107
Q

ionisation behaviour

A

determine the pKa pKb via various technique such as potentiometric titration

knowing this allows you to change the pH a bit to increase solubility

for example you can transform in into a saltpa

108
Q

partition coef

A

log P log D determine lipophilic or hydrophilic behaviour and help to see the absorption potential

109
Q

solid state prop

A

API crystaline or amorphous?

morphous very unstable no melting transition liquid like solid

knowing this is important to get the most stable form

110
Q

stability

A

in solid state - ingluence of heat, lightn water etc

stability in solution - heat, pH etcoxifising you want to challenge the stability here

try compatibility with excipient here too

111
Q

antibodies are eliminated via

A

catabolic processes such as reticuloendthelial system

112
Q

antibodies are abosrbed via

A

SC or IM or IV instead of oral,

convection or lymphatic uptake

113
Q

reimbursement is decided by

A

Minister of Social Affairs, following a recommendation by the Medicines Reimbursement Committee, which forms part of the National Institute for Health and Disability Insurance (NIHDI)

114
Q

correlate of protection

A

specific immune marker that is associated with proteintion afinst an infection

115
Q

EMA

A

support innovations by checking project management, coordination, admministration but no technical expertise. Main responsibility is protection ad promotion of public and animal health

publish guideline

plays a role in simulation innovation and research

116
Q

medical department

A

r and d
regulatory
acess
commercialisaiton

117
Q

empirical statistical models

A

are descirptive models and not predictive. They rely on data as source of knowledge but has no assumptions

118
Q

pharmacometrics

A

it is kind of in the middle of empirism and rationalism
it is more pragmatic but still data driven. it is part of clinical development and can interpolate

it basically gives a bruge between observation and understnading

learning and confirming by taking into account variability but still not too lmulch assumption

119
Q

systems pharmacology/PBPK

A

is based on system biology and pharmaco dynamic kinetic. It is based on a lot of assumptions and is knowledge drive.
it can be used for extrapolation between populations
usually used in preclinical, for dose selection etc

physiologically base pharmacokinetic

pharmaceutical medicine (4 decks)

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