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Intro to Pharmacology > Pharmacodynamics - Clinical Trials > Flashcards

Pharmacodynamics - Clinical Trials Flashcards

1
Q

Phase I clinical trials involve which type of individuals?

A

Healthy individuals

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2
Q

What is pharmacology?

A

The body of knowledge gathered on the understanding of how therapeutic agents (Drugs) work

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3
Q

Effective therapeutic agents should improve what?

A

QoL

Life expectancy

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4
Q

What is the governing body of drugs in Canada?

U.S?

A

Canadian Department of Health and Welfare

US Food and Drug Administration

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5
Q

What are the main issues in which QA is needed by these drug governing agencies?

A

The drug has to be safe and effective

The drug needs to be able to be administred in a suitable fashion

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6
Q

When do we determine if a drug can be administered in a suitable fashion?

A

Preclinical and clinical trials

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7
Q

Preclinical trials are what?

A

Completed in-vitro in the lab or using an animal model

clinical trials are specific to humans

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8
Q

Patenting:

  • Carried out as soon as a __________ useful drug is ________
  • Carried out before ________ and ________ ______s
  • ______ years of patent ______ are lost due to _____
  • Patent a _______ of compounds rather than an ________ _________
  • Also patent ________ ________
A

Carried out as soon as a [potentially] useful drug is [identified]
Carried out before [clinical] and [preclinical trials]
[Several] years of patent [protection] are lost due to [trials]
Patent a [group] of compounds rather than an [individual structure]
Also patent [production method]

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9
Q

What is the purpose of patent protection?

A

Protect the intellectual property which you dumped a substantial amount of money for R&D.

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10
Q

How is a patent lost?

A

If no new uses are found.

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11
Q

How lojng is the patent pending period?

A

around 10 years

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12
Q

Regulatory affairs of patenting:

  • Drug must be approved by ______ ______ (ex?)
  • Proper _______ is essential. Must demonstrate:
  • ___
  • ___
  • ____
A

Drug must be approved by [regulatory bodies]
[ex: FDA, European Agency for the Evaluation of Medicinal Products]
Proper [record-keeping] is essential.
Must demonstrate:
- [GLP - good laboratory practice]
- [GMP - Good Manufacturing Practice]
- [GCP - Good Clinical Practice]

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13
Q

What are the three main components of Preclinical trials?

A

Toxicology (report)
Pharmacology (report)
Formulation (report)

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14
Q

What is involved for determing toxicology in pre-clinical trials?

A

In-vivo (gen. animals) and in-vitro tests for acute and chronic toxicity

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15
Q

What is acute toxicity?

A

Toxicity within 24 hours

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16
Q

What is chronic toxicity?

A

Toxicity for longer than 24 hours

17
Q

What is the pharmacology portion of preclinical trials?

A 
Pharmacokinetics - ADME
- Identification of drug metabolites and their properties
Pharmacodynamics
Drug actions
- selectivity of action at drug target
18
Q

What is the formulation portion of preclinical trials?

A

Stability tests and method of delivery

19
Q

In what trial and what portion are activation, transactivation, etc, properties determined?

A

Preclinical trials

- ADME studies

20
Q

What is a stability test?

A

When the drug is made into a tablet form for example, left out in the sun or how a patient might leave it and see how long it stays stable
- determine expiry date from here.

21
Q

What is the expiry date of a drug based on?

A

Time length before a drug’s change is over 5% of the purported value

22
Q

When would using a drug after the expiry date really not be advised?

A

When the drug TI is low

23
Q

Phase 1 Clinical trials

  • Always carried out in ________ ________
  • Useful in establishing _____ ______
  • Useful for studying _______, including drug __________
A

Phase 1 Clinical trials:

  • Carried out in [healthy volunteers]
  • Useful for establishing [dose levels]
  • Useufl for studying [pharmacokinetics], including drug [metabolism]
24
Q

Phase 2 Clinical Trials:

  • Carried out on ______
  • Carried out as ______ _______ studies
  • Demonstrates whether a drug is __________ useful
  • Establishes a _______ regime
  • Identifies ______ ______
A

Phase 2 Clinical Trials:

  • Carried out on [patients]
  • Carried out as [double blind] studies
  • Demonstrates whether a drug is [therapeutically] useful
  • Establishes a [dosing] regime
  • Identifies (potential) [side effects]
25
Q

Often, in phase 1 clinical trials, a ____ dose is given to healthy individuals.

A

low

26
Q

Rather than giving a placebo in a double blind, what do doctors now give to patients not receiving the ‘treatment’?

A

A drug with a`similar effect that is already on the market, rather than the new drug being tested.

27
Q

Phase 3 clinical trials:

  • Carried out on a ______ number of patients
  • Establishes _______ proof for _______ and ________
A

Carried out on a [larger] number of patients

Establishes [statistical] proof for [efficacy] and [safety]

28
Q

Phase 4 Clinical trials:

  • Continued after a drug reaches the _______
  • Studies _____-term effects when used _______
  • Identifies unusual ____ ______
A

Phase 4
Continued after a drug reaches the [market]
Studies [long]-term effects when the drug is used [chronically]
Idenitifes unusual [side effects]

29
Q

Why is PMS (postmarketing surveillance) used?

A

Drugs are approved on the basis of clinical trials, which use a reduced number of individuals and do not present other medical conditions.
PMS allows one to understand how drugs may act in these instances.

30
Q

PMS can further refine, or confirm or deny, the safety of a drug after it is used in the general population by: (two factors)

A

Applying the drug to a large number of people who have varying medical conditions

31
Q

What are different surveillance methods or approaches used in PMS?

A 
Spontaneous reporting databases
Prescription event monitoring
Electronic health records
Patient registries
Recording of linkages between health databases

Intro to Pharmacology (23 decks)

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