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PT3001: Introduction to Pharmacology > Drug Development I: Pre-Clinical > Flashcards

Drug Development I: Pre-Clinical Flashcards

1
Q

What are the THREE main phases of drug developments?

A
  1. Discovery
  2. Development
  3. Commercialisation
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2
Q

What is involved in the Discovery / Design of new drugs?

A
  • Chemical modification of known molecules
  • Screening of natural products or chemical libraries for useful biological activity
  • Rational drug design
  • Biotechnology
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3
Q

What is involved in Preclinical Studies?

A

In vitro and animal models assumed to help predict EFFICACY and TOXICITY in humans

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4
Q

What TWO levels are involved in In Vitro testing?

A
  1. Molecular screening
  2. Cellular and Tissue screening
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5
Q

What is involved in In Vitro Molecular Screening?

A
  • Receptor binding affinity
  • Selectivity for receptor & receptor subtype
  • Effect on appropriate enzymes (P450 etc)
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6
Q

What is involved in In Vitro Cellular & Tissue Screening?

A
  • Efficacy in cultured cells (agonist or antagonist?)
  • Activity / selectivity in isolated organs or tissues
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7
Q

What are the main FOUR advantages of In Vitro testing?

A
  1. Small amounts of test substance needed
  2. Fast, cheap, reliable screening to identify molecules of interest
  3. Can use human cells / tissue
  4. Variables can be controlled
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8
Q

What are the main FOUR limitations of In Vitro testing?

A
  1. Only as good as the disease model or hypothesis
  2. Effects of drug metabolites not usually measured
  3. Action in vitro may not be achievable in vivo unless the drug can reach its target (pharmacokinetics)
  4. Doses used may not be achievable in vivo
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9
Q

What is Acute Toxicity?

A

Effects of large doses up to the lethal level

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10
Q

What is the length of study needed for Acute Toxicity testing?

A

2-week studies in 3-4 species

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11
Q

What is a ‘No Effect Dose’?

A

Max. dose at which toxic effect is not seen

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12
Q

What is Minimum Lethal Dose?

A

Min. dose that kills any animal

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13
Q

What is Sub-Acute & Chronic Toxicity?

A
  • Effects of repeat doses
  • Identify toxicity & target organs
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14
Q

What is the length of study needed for Sub-Acute & Chronic Toxicity testing?

A

3-month studies in 2 species

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15
Q

What are the other THREE types of toxicity?

A
  1. Reproductive
  2. Carcinogenicity
  3. Mutagenicity
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16
Q

What are the main FIVE limitations of Preclinical Testing?

A
  1. Time & cost
  2. Large numbers of animals needed
  3. Animal model of human disease may not be available
  4. Limits on extrapolating animal data to humans
  5. Rare adverse side-effects not detected

PT3001: Introduction to Pharmacology (18 decks)

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