ASC306 > Drug discovery & development > Flashcards

Drug discovery & development Flashcards

(41 cards)

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1
Q

Properties of arecoline…

A
  • intense SM contraction
  • acetylcholine agonist
  • natural alkaloid
  • chewed by humans as stimulant
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2
Q

Properties of penicillin…

A
  • Mould on bread used to treat wounds in ‘ancient’ times
  • 1870 England mould covered culture did not produce bacteria
  • Joseph Lister described AB property on human tissue
  • 1928 Alexander Fleming isolated penicillin from A. notatum
  • 1938 Howard Florey produced stable form of ‘penicillin’
  • 1941-1943 industrial production of penicillin began
  • 1952 acid stable oral penicillin developed
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3
Q

What is curare?

A 
paralysing poison (Sth American Indians) 
acts on voluntary muscles -> asphyxiation
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4
Q

How did the development of curare come about?

A

1596 - 1st reported by Walter Raleigh
1825 - shown if animal kept breathing, would not die
1850 - shown to be effective in tetanus & strychnine poisoning
modern med. - used in anaesthesia as muscle relaxant

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5
Q

Why didn’t American Indians die after eating animals killed with curare?

A

because molecule too big to cross gut mucosa

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6
Q

Why is herion useful?

A

it gets converted to morphine in the body -> powerful analgesic

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7
Q

When was morphine 1st made synthetically? Use?

A

1874, to treat severe pain

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8
Q

The discovery of ivermectin…

A
  • 1975 Merck lab workers studied soil samples (golf course) from Japan
  • soil had high [macrocyclic lactone] produced by fungus Streptomyces avermitilis - antihelmintic (killed round worms)
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9
Q

What was invermectin initially developed to treat?

A

African River Blindness (Onchocerca volvulus) - very effective & used in mass drug treatments

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10
Q

First step in drug development…

A

Screening, examining & synthesising 10,000 - 25,000 chemical entities ~ 3 years

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11
Q

Development and testing involves what? How many years?

A

Preclinical tests (animals) using 10 - 20 chemical entities ~ 7 years. Also includes phase I, II & III

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12
Q

Phase I of drug development…

A

5 - 10 compounds 1 year. Small group of exp. animals to assess SAFETY, TOLERABILITY & PHARMOKODYNAMICS

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13
Q

Phase II of drug development…

A 
2 - 5 drugs
Tests EFFICACY (how well drug works)
larger group of animals 
test & control groups are same age, sex, weight
randomised, blinded (single), placebo
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14
Q

Phase III of drug development…

A

2 drugs ~ 2 years
larger group - field trials 100 - 1000’s subjects
different countries, geo. areas, climatic zones

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15
Q

Phase IV of drug development…

A

postmarketing surveillance
ongoing safety monitoring etc.
reporting adverse reactions

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16
Q

What is the APVMA?

A

Australian Pesticide and Veterinary Medicines Authority

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17
Q

Adverse reactions to drugs get reported to who? What actions may be taken?

Study These Flashcards
A

APVMA - may cancel or review registration of drug, and/or change conditions of use of product

18
Q

What are some roles of Independent Research consultants…?

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A
  • specialists in defined area
  • hired by companies to undertake specific studies (eg. efficacy)
  • have their own facilities
  • consultants run study under Good Clinical Practice (GCP) protocols
19
Q

What is GCP? Which organisation is it closely associated with?

Study These Flashcards
A

Good Clinical Practice closely associated with the Veterinary International Committee for Harmonisation (VICH)

20
Q

What principles does the VICH uphold?

Study These Flashcards
A

Internationally accepted guidelines for the study of veterinary therapeutics (includes Aus, USA, EU and Japan)

21
Q

What are some other guidelines of GCP?

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A
  • rigid recording requirements
  • reduce repeats of similar/same studies for international registrations
  • reduce no. of animals used in product development
  • minimise costs
  • minimise ethical dilemmas
22
Q

What are some of the approvals/regulations required for consultants undertaking GCP efficacy studies?

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A
  • Animal Experimentation Ethics Committee (AEEC)
  • conform to Universities Federation for Animal Welfare (UFAW)
  • obtain quarantine authority approval (AQIS-Approved Premesis & Personnel)
23
Q

What are the 4 different roles of peeps involved in GCP studies?

Study These Flashcards
A
  • Sponsor (funding clinical study undertaken by independent consultant)
  • Monitor (company rep. to make sure investigator adheres to GCP)
  • Investigator (scientist with specialist skills on behalf of the company. NOT a company employee)
  • Regulator (member of independent organisation assessing applications for new drug registration. In Aus it’s the APVMA)
24
Q

GCP recording mantra…

Study These Flashcards
A

“If it has not been written down, then it never happened”

25
All records should be...?
signed or initialed and dated
26
What are the roles of the Australian Pesticides & Veterinary Medicines Authority (APVMA)?
- chemical regulation - risk assessment - reidue management & quality assurance - international co-operation
27
T or F - veterinary medicine can include electrolytes, herbicides, direct fed microbials, enzyme-based products...
true
28
What is the vet chemical regulation organisations in Aus?
- The 'National Registration Scheme' including APVMA
29
Have a look at slide 41 and understand relationships within Agvet chemical management in Aus.
...
30
List some groups in the APVMA Operating Environment
- External service providers (state departments, Dept. of Environment & Water Resources) - Customers & stakeholders (Aus & state dept's, consumers & public, Registrants & Agvet Chemical industry) - advisory board - minister - International counterparts
31
3 main APVMA roles...
1. Assessment of chemicals before & when on market -> outcome -> active constituent & prod. registration & label approval 2. On-going quality of chemicals -> vet meds & pesticides 3. Industry compliance -> non-compliance monitoring, adverse experience reporting
32
How long does the APVMA registration process take?
up to 15 months (new products)
33
T or F - APVMA existing chemical review process does not involve public input
false there are opportunities for public input
34
Risk assessment regulatory decisions involve...?
- approving active constituents - registering products - approving labels - issuing permits
35
Products can only be registered/approved if which criteria are met?
- is not undue hazard to people - does not have unintended harmful effects on plants, animals or environment - does not unduly prejudice trade - is shown to be effective
36
What is MRL?
Maximum residue limits
37
How are MRLs determined?
- define components of residue - from representative field trials - Good Lab Practice requirements to be satisfied - witholding period or pre-harvest interval - include feeds & animal comodities
38
Re. dietary exposure assessment, define chronic exposure
lifetime exposure to chemical from residues in food corresponding to acceptable dietary intake (ADI) - requires appropriate food consumption data for general population
39
Re. dietary exposure assessment, define acute exposure
short-term exposure (24hr) to chemical from residues in food corresponding acute reference dose - requires appropriate food consumption data for various age groups and general population
40
2 bodies in charge of Chemical Residues Management in Aus?
- APVMA (risk assessment) | - FSANZ (Food Standards Australia and New Zealand)
41
Why are MRLs important to Aus? What other committee is important?
they are legally recognised for trading purposes | CODEX = international committee comprising toxicology and residue experts set residue limits for trade
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