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Pharmacology And Toxicology > Pharmacology L2 > Flashcards

Pharmacology L2 Flashcards

1
Q

Stages of drug discovery& development

A
  • drug discovery
  • preclinical development
  • clinical development
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2
Q

Drug discovery

A

Identification of candidate molecules based on their pharmacological, biochemical and physiochemical properties

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3
Q

Preclinical development

A

Non-human studies to determine basic pharmacokinetics, potential toxic side effects and formulation. These can take a long time

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4
Q

Clinical development

A

Evaluation of drug safety, side effects, efficacy and optimum dosage in volunteers and patients

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5
Q

Stages of drug development

A
  • chemical or biochemical synthesis of novel compound
  • isolation of active ingredient from natural source
  • production and isolation of biologicals
  • preclinical testing 1/2/3
  • phase 0/1/2/3
  • approval
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6
Q

Chemical or biochemical synthesis of a compound involves what?

A

Screening of the compound

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7
Q

Pre-clinical testing 1b involves?

A

Effects of drug on cellular function. How does it affect biological response? Is it an agonist, antagonist, modifier?

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8
Q

Pre-clinical testing 2 involves?

A

Mechanism of drug action. Is it blocking a pathway or is there a reaction

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9
Q

Pre-clinical testing 3 involves?

A

Toxicity testing ( in vivo, in vitro & ex vivo)

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10
Q

Phase 0 is what?

A

Human microdosing

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11
Q

What does phase 0 entail

A

Small amount of volunteers use non-pharmacological doses to see if there are any effects on cellular function, drug action and toxic side effects

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12
Q

What does phase 1 entail

A

Does the drug have any effects on body function, drug safety, unexpected side effects

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13
Q

What is phase 1

A

Clinical trial on healthy subjects (very small no;10-80)

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14
Q

What is phase 2

A

Clinical trial on small number of selected patients (100-300)

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15
Q

What does phase 2 entail

A

Effect on pathophysiology of the disease, therapeutic dosage.

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16
Q

What is phase 3

A

Clinical trial on diverse large group of patients (>1000)

17
Q

Approval of drug development is usually carried out by?

A

Licensing by National regulatory agency

18
Q

Regulatory agency in US and Europe

A

US- FDA (world standard)
EMA- European Medicines Agency

19
Q

What is phase 4?

A

Post-licensing phase
Clinical trial: long-term benefit-risk evaluation
Large and extremely diverse patients

20
Q

What does phase 4 entail?

A

Pharmacovigilance; determination of therapeutic value of novel drug or delivery system. Adverse effects in previously untested patient groups

21
Q

What does phase 3 entail?

A

Comparison to other therapies and placebos

22
Q

When do medical and ethical approval occur?

A

Before clinical development

23
Q

When does regulatory approval occur?

A

Before post-licensing surveillance

24
Q

Most drug targets are proteins like?

A
  • receptors
  • transporters
  • enzymes
25
Q

Target selection is often based on biomedical knowledge on

A
  • disease mechanisms
  • biochemical pathways
  • cellular signalling
26
Q

Pre-clinical testing is usually carried out on?

A
  • animal(mice, rats, rabbits)
  • animal models of human disorders
  • isolated organs
  • cell cultures (in vitro assay systems)
27
Q

Preclinical testing in animals involves?

A
  • determination of median effective dose ED50
  • assessment of toxicity
  • assessment of subacute toxicity (once lethal dose has been determined)
  • estimation of human dose
  • assessment of chronic toxicity
28
Q

What are clinical trials

A

A set of tests prior to the approval of a new health intervention

29
Q

Health interventions that require diff degrees of testing are

A
  • pharmaceutical targets
  • novel drug derivatives
  • new drug combinations
  • diagnostics
  • medical devices
  • therapy protocols
30
Q

Preclinical and clinical trials are organized to?

A

Determine essential data sets on the safety and efficacy of novel health interventions

31
Q

Initial requirement prior to start of extensive clinical trials

A
  • provision of satisfactory information on the quality of non clinical safety to National Health Authority
  • ethical approval by an independent National Ethics Committee
32
Q

Authorization to conduct a clinical trial js carried out by

A
  • pharmaceutical company
  • medical institution
  • academic institution
  • specialist clinical research company
33
Q

After expiration of patent product, what is produced?

A

A generic drug under a different brand name which has to be tested again

34
Q

Generic drugs can lead to?

A
  • analogue drugs
  • new drug combinations
35
Q

Analogue drugs

A

Imitation of chemical structure due to slight, but biochemically irrelevant, modifications of established drug molecule.
May have diff properties, may not be active

36
Q

New drug combinations

A

Essential active substance plus low-dose indifferent second substance. Has to be tested again

Pharmacology And Toxicology (6 decks)

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