L3: Drug Discovery and Development Flashcards
Give an overview of Arecoline.
- Natrual alkaloid
- Acetylcholine agonist
- Comes from betele palm nut
- Used for getting tape worms out of dogs
- Causes intense smooth muscle contractions to dislodge tapeworms
- Also chewed by humans as a stimulant (natrual high)
How did penicillin originate?
Romans would place mouldy bread on patient wounds.
Give an overview of Curare.
- Extracted from a vine
- Paralysing poison used by South American Indians
- Relaxation of breathing muscles - leads to asphyxiation
- If you can keep an animal breathing it will not die
- Effective in tetanus and strychnine poisoning
Can you eat an animal that has been killed with curare?
Yes - the molecule is too big to cross the gut mucosa
Give an overview of heroin.
- Made from opium which is produced from poppies
- Converted to morphine (a powerful analgesic)
When was morphine first made synthetically?
1874
Give an overview of Ivermectin.
- Dewormer
- Kills roundworms
- A fungi that was discovered in a golf bunker that contained high concentrations of macrocydic lactone
- Initially developed to treat African River Blindness
What is Praziquantel used for?
- Tapeworms in dogs, cats, and livestock
- Treatment of neural cystiverosis in humans (pork tapeworm)
- Not effective against roundworms
- Low toxicity
- Mode of action not known
How and when was Praziquantel developed?
Mid 1970s
The molecule was built.
What are the factors to consider with natrual health remedies?
- what is in it?
- what is the active?
- how much active is present?
- how much active is therapeutic
- how much active is dangerous
- how to maintain standard active concentration
- efficancy trial data
- shelf life
- data showing product doesnt cause harm
What is involved in Phase I of a new product assessment?
- Studies with small groups of experimental animals to assess safety, tolerability, and pharmacodynamics.
- High levels of monitoring, measuring, observation, and vet input.
- Meticulous, copious record taking
What is involved in Phase II of a new product assessment?
- Assessent of how well the drug works
- Use of larger group of animals
- Experimental and control groups are sex, age, and weight matched
- Studies are randomised, blinded, and may have placebo controled.
What is involved in Phase III of a new product assessment?
- Assess effectiveness of the drug
- Large field trials often including hundreds to thousands of experimental subjects
- Multicentre trials (in different countries or areas)
- Registration, production, sale, distribution
What is involved in Phase IV of a new product assessment?
- Post marketing survelliance
- Ongoing safety moniotoring
- Reporting of any adverse reactions
Where do vets report adverse reactions of a new drug to?
To the company
Company report to APVMA (Australian Pesticides and Veterinary Medicines Authority)
What does an Independent Research Consultant do?
- Hired by companies to undertake specific studies (eg efficiacy studies)
- They are specialised in defined areas (eg. tapeworms)
- Have their own faciliaties
- Writes final reports of studies which company has no input of.
What is Good Clinical Practice?
Internationally accepted guidelines for studies for the testing of veterinary therapeutics.
What is the VICH and what is its purpose?
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products.
Encompasses best judgment of the regulators
Base for public assurance
Clearly defined procedures
Record keeping requirements
Ensures accountability and traceback
What are the roles of people involved in GCP studies?
Sponser: company who developed the drug and funds the clincal study to be done by independent consultants
Monitor: Ensures investigator adheres to GCP
Investigator: Scientist undertaking trial on behalf of company
Regulators: Assess applications from companies for registration of a new vet drug
What is the role of APVMA?
- Chemical regulation in Aus
- Risk assessment
- Residue management and quality assurance
- International co-operation
What are the requirements of registiring and approving chemicals?
- Not an undue hazard to people
- does not have an unintended harmful effect on plants, animals or the environment
- does not unduely prejudice trade
- shown to be effective
How are Maximum Residue Levels determined?
- Define components of the residue
- Representative field trials
- Good lap practices
- Associated with a withholding period or pre-harvest interval
- Feeds and animal commodities
