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Medicinal Chemistry > Drug Development Process 1 > Flashcards

Drug Development Process 1 Flashcards

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1
Q

Define a drug

A

A chemical compound of defined structure that upon administration to a living organism produces a biological effect.

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2
Q

What can a chemical compound be?

A
  • A natural product which is isolated and purified
  • Synthetic i.e. made by a chemical process
  • Semi - synthetic
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3
Q

What is a medicine?

A

A chemical preparation which contains a drug and other substances.

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4
Q

What can be prescribed for waterborne parasites?

A

Pomegranate as it contains a powerful antihelminthic.

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5
Q

When did the Royal Pharmaceutical Society form and what did they do?

A

In 1841
They began legislating for higher standards

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6
Q

What did the Venereal diseases act of 1917 lead to?

A

The control of unsubstantiated claims for medicines
- Thought as one of the forbears of evidence based medicine

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7
Q

What happened in 1956 for the development of legal framework?

A

Previous legislation was rationalised and the control of both the sale and manufacture of medicines was combined into a single piece of legislation.

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8
Q

What is extemporaneous dispensing?

A

The preparation of a medicinal product for an individual patient by the instruction from a doctor.

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9
Q

State the standards for the following elements of extemporaneous dispensing.

A
  • Personal hygiene
  • Personal protective equipment
  • Work area and equipment
  • Label preparation
  • Avoidance of contamination
  • Suitable record keeping and processes
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10
Q

Why were galenicals made?

A
  • To separate active compounds from inactive from plants
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11
Q

How were galenicals made?

A
  • By macerating a crude drug with a solvent
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12
Q

Why were pills good to make?

A
  • Easy to make
  • Compact
  • Could mask foul tastes
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13
Q

What are the problems with pills?

A
  • Were often coated in insoluble materials and too dense
  • This meant they often went through the GI tract unchanged and unabsorbed.
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14
Q

What is aromatic water?

A
  • An aqueous solution of a volatile substance
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15
Q

What is aromatic water used for?

A
  • Flavouring agent
  • Some do have mild therapeutic actions usually carminative
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16
Q

How are waters now prepared?

A
  • From their concentrates; must be diluted with 39 times its volume of potable water to make a single strength water
17
Q

How do you make money on a drug?

A
  • Stop other people selling it who don’t have the cost of developing it
  • Market it
  • Develop a patentable formulation
18
Q

What must you show to patent an entity (not just a drug)?

A
  • Must be novel
  • Must involve an inventive step
  • Must have utility
19
Q

What is the lifespan of patents?

A

20 years

20
Q

Describe discovery of a target selection/assay development.

A
  • Starts with research into disease mechanisms to identify potential targets that a drug could work on
21
Q

What is the next stage of drug discovery?

A

Finding a chemical agent that will act specifically on the target - which is called a lead

22
Q

Describe the sources of leads.

A
  • Originally relied on natural sources
  • Now we are able to ‘design’ leads
23
Q

State the 5 sources of leads.

A
  • ‘Design’
  • Plant
  • Marine
  • Microorganism
  • Semi - synthetic
24
Q

Describe lead selection - SAR

A
  • Develop an assay that displays interaction of your molecule with the
    target plate based/cell based
  • This identifies ‘drug like’ chemistry that is active against the target
  • Possible to start at this stage if you have a chemical you know has an effect
25
Q

Describe lead refinement.

A
  • Activity/Potency (how well it works)
  • Selectivity (how well it binds just to your target)
  • Stability (will the compound fall apart in solution?)
  • Toxicity
  • Solubility
26
Q

Describe pre-clinical development.

A
  • Routes of manufacture and purity
  • Partition co-efficient and pKa
  • Crystal properties- polymorphism
    (solid state)
  • Particle size
  • Dissolution
  • Biopharmaceutical properties
  • Chemical stability- long term
  • Robust analytical methodologies
  • Routes of administration and
    formulation
27
Q

Why do we use animals?

A

In the body a drug may have problems we can’t
predict It may:-
* be deactivated before it reaches the part of the
body where it needs to act
* be quickly excreted from the body
* be changed in the body to a different chemical,
may become inactive or toxic
* Affect other parts of the body as well
* have unwanted side effects

28
Q

What are the principles of 3Rs for animal testing?

A

Refinement
- Development of methods to reduce distress to animals

Reduction
- Obtain most precise information with smallest number of animals

Replacement
- Use of alternatives to animals

29
Q

How do we screen the drugs in animals?

A
  • Small doses of drug are given to mice (or rats) with a tumour
  • The tumour size is measured
    regularly to check for a response
  • The animal is under close watch to check for side effects
30
Q

Why do we animals have their own care team?

A
  • To check if the drug kills the cancer cells inside the body and at what dose it does this
31
Q

What are clinical trials?

A

Human trials:
Phase 1 - involve a small number of volunteers
People given small doses of drug and carefully monitored
Trial tests whether the new drug is safe and how the body deals with it
Phase 2a/b - involves small number of patients
Designed to test whether the new drug has a positive effect on the disease being treated and determine the dose
Phase 3 - involves a large number of patients
Trails tests efficacy and safety in a larger population
Phase 4 - Post marketing safety and efficacy

32
Q

Where might drugs come from in the future?

A
  • genomics
  • proteomics
  • metabolomics
33
Q

Describe genomics?

A

Study of the genome of an
organism.

34
Q

Describe proteomics.

A

Study of the structure and
function of proteins

35
Q

Describe metabolomics.

A

Studying the cell’s activities via its metabolites

Medicinal Chemistry (21 decks)

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