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ASC306 > Drug discovery & development > Flashcards

Drug discovery & development Flashcards

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?

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…?

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?

A

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

20
Q

What principles does the VICH uphold?

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?

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?

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?

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…

A

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

25
Q

All records should be…?

A

signed or initialed and dated

26
Q

What are the roles of the Australian Pesticides & Veterinary Medicines Authority (APVMA)?

A
  • chemical regulation
  • risk assessment
  • reidue management & quality assurance
  • international co-operation
27
Q

T or F - veterinary medicine can include electrolytes, herbicides, direct fed microbials, enzyme-based products…

A

true

28
Q

What is the vet chemical regulation organisations in Aus?

A
  • The ‘National Registration Scheme’ including APVMA
29
Q

Have a look at slide 41 and understand relationships within Agvet chemical management in Aus.

A

…

30
Q

List some groups in the APVMA Operating Environment

A
  • 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
Q

3 main APVMA roles…

A
  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
Q

How long does the APVMA registration process take?

A

up to 15 months (new products)

33
Q

T or F - APVMA existing chemical review process does not involve public input

A

false there are opportunities for public input

34
Q

Risk assessment regulatory decisions involve…?

A
  • approving active constituents
  • registering products
  • approving labels
  • issuing permits
35
Q

Products can only be registered/approved if which criteria are met?

A
  • 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
Q

What is MRL?

A

Maximum residue limits

37
Q

How are MRLs determined?

A
  • 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
Q

Re. dietary exposure assessment, define chronic exposure

A

lifetime exposure to chemical from residues in food corresponding to acceptable dietary intake (ADI)
- requires appropriate food consumption data for general population

39
Q

Re. dietary exposure assessment, define acute exposure

A

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
Q

2 bodies in charge of Chemical Residues Management in Aus?

A
  • APVMA (risk assessment)

- FSANZ (Food Standards Australia and New Zealand)

41
Q

Why are MRLs important to Aus? What other committee is important?

A

they are legally recognised for trading purposes

CODEX = international committee comprising toxicology and residue experts set residue limits for trade

ASC306 (13 decks)

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