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FUN > Medicines Pathway > Flashcards

Medicines Pathway Flashcards

1
Q

What are stages bringing a drug to market?

A
  1. Drug discovery
  2. pre-clinical trials
  3. Clinical trials
  4. pharmacoviliglance/post marketing surveillance
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2
Q

What is the aim of each stage of bringing a drug to market?

A
  1. discovery- understanding disease or ailement and taget + identify the drug needed
  2. pre-CTs- assess the PK profile
  3. CTs: phase I- assess the ADME profile, safety + side effects
    phase II- efficacy, side effects
    phase III- comparison of drug to current interventions/placebo
  4. Pharmocovigilance-monitor the new med in practice.
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3
Q

How are drug candidates chosen for pregression to pre-clinical stage?

A
  1. around 10,000 of known or NCEs are tested
  2. around 250 ‘hit’
  3. around 10-50 ‘lead’ compounds are identified
  4. ‘lead’ compounds are optimised through QSARs -usually 3-5
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4
Q

What are SARs and QSARs?

A
  • Structure activity relationships and quantitative structure activity relationships

SARs= changes in structure of a molecule and how they relate to the effects on the molecular target

QSARs= a process of modelling mathematically the relationship between structure and activity

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5
Q

What are the advantages of testing compounds from natural sources?

A
  • lots of potential for variety of new compounds
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6
Q

What are the sources of compounds for drug development?

A
  • Natural materials
  • compound libraries
  • computerised simulations
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7
Q

Disadvantages of natural compounds for drug development

A
  • time consuming
  • complex doesn’t tend to cross GI tract
  • if can’t cross GI then need to be administered via injection
  • injections aren’t appealing to public so poor selling point
  • complex and hard to synthesis
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8
Q

Describe how compound libraries work?

A
  • An array of compounds (previously used or NCEs)
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8
Q

How are new compounds synthesised?

A

via combinatory chemistry:
-in a larger reactor are substrates and common molecules found in most drugs.
-lots of different combinations are made
-isolated and purified

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9
Q
A
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9
Q

What are the disadvantages of ONLY using compund librabries?

A
  • time consuming
  • some/most may not interact, so wasted materials
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10
Q

Compound libraries are used in combination with….

A

Computerised simulations

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11
Q

What are computerised simulations and why are they used in drug discovery?

A
  • they model interaction using virtual compounds and virtual targets
  • they are used so the best virtual compounds are chosen for synthesising
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12
Q

Pre-clinical trials: advantages of In vitro

A
  • HTS (high throughput screening) is possible
  • Cost effective
  • human models can be used
  • mechanisms can be studied
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13
Q

Disadvantages of In Vitro

A
  • models are simplified
  • often different fron In Vivo tissue
  • No interconnections between different biological systems
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14
Q

How are animal studies conducted?

A
  • PK profile: ADME
  • Toxicity- increasing doses to determin max effective dose
  • determine therapeutic window
15
Q

CTA is split into 3 parts, which are ….

A
  • Chem + formulation data
  • In Vitro and animal studies data
  • Clinical trials protocols
16
Q
A
17
Q

Explain phase I trials

A
  • on healthy volunteers except unethical then only performed on one type of patient
  • clinical setting-clinical research unit- CRU
  • drug is administed i formulation
  • monitoring
18
Q

What is monitored during phase I trials?

A
  • record side effects
  • physical examinations
  • blood/urine samples for AMDE profile
19
Q

how does phase I trials conducted?

A
  • randomised groups -computer generated
  • Double blind and placebo trials
  • doses are increases when PK profile is expected and ni adverese effects
  • max dose stop when pre-determined max therapeutic conc is reached
  • does frequency is tested
  • cross-over of groups
  • effect with food is tested- with high fat meal
20
Q

How are phase 2 tials conducted?

A
  • 100-300 patients with disease
  • patients of high homogeneity chosen
  • different doses and dose frequencies are tested
  • side effecs are monitored
  • efficacy is determined
21
Q
A
22
Q

describe how phase III trials are conducted?

A
  • current intervention/placebo is compared with drug
  • broad patient population-involving 2-3 hospitals
  • expensive
  • cross over and double blind trials
23
Q

Describe pharmacovigilance

A
  • monitoring of medicine to population + in practice
  • adverse effects? and in some more than others
  • improve quality of life
  • better value than other treatments
24
Q

What license of drugs cannot be marketed or promoted during pharmacovigilance?

A

POMs

24
Q

why is marketing and promotion done during the pharmacovigilance stage?

A
  • Cover costs in the development and re-invest in other discoveries
  • promote use in healthcare practices
  • inform scientific and medical community of a new drug in market
25
Q

What are the different applications needed to be made for a drug to go into market?

A
  • CTA
  • MA
26
Q

state and describe the first application needed to be made after drug discovery?

A
  • CTA- allows for manufacture for sale/supply for trial, use, import to UK for trials
  • EAMS- allows for people with life threatening/debilitating conditions to use unlicensed meds when there are no alternatives
27
Q

What is still needed for EAMSs ?

A

Pharmacovigilance- if harmful then it is stopped

28
Q

state and describe the types of applications can be made follwing CTs?

A
  • MA- data is scrutinised for evidence of safety and efficacy, if MHRA are satifised then MA is granted
  • Abridged application- for generic medicines, a shorter MA application, still results in an MA
29
Q

What does MA grant?

A
  • med classification- type of license, who and what for
  • sale/ supply, import/export, manufacture and assemble for wholesalers and pharmacies
30
Q

Before market launch of med, describe what must happen?

A
  • ML-manufacturing license
  • Manufaturing facility inspection by NHRA
  • GMP ( good manufacturing practice) is tested by QP

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