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HSS3106 - Pharmacology > Lecture 17- Drug Manufacture and clinical trials > Flashcards

Lecture 17- Drug Manufacture and clinical trials Flashcards

1
Q

What is the game of pharm. companies?

A

to make a profit!!

tend to focus in on common problems than diseases that affect small amount of population

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2
Q

What are the 3 types of Pharm. companies?

A
  1. Subsidiaries of foreign multinational companies
  2. Generic
  3. Small Biotech
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3
Q

What are Subsidiaries of foreign international companies?

A

manufacture brand name drugs

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4
Q

What are generic companies?

A

manufacture drugs that are ineligible for patents or drugs where patents have expired pr drugs that they have received compulsory licenses

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5
Q

What are small biotech companies?

A

just at stage of developing products
usually one or two on market

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6
Q

How are new drugs discovered?

A
  • BROAD TO NARROW
  • begin in lab –> find cell and genetic factors that play role in specific diseases
  • search for chemicals and biological substances that target biological markers and have drug-effects
  • lots of testing
  • 3-6 year of testing on patients
  • approval of ONE drug on market
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7
Q

What are the general steps to new drugs getting discovered?

A
  1. Target identification
  2. Target prioritization/validation
  3. LEad identification
  4. Lead optimization
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8
Q

What is “Target Identification”?

A

drugs usually act on either a cellular or genetic chemicals in body known as target s

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9
Q

What is “Target Prioritization” ?

A

to select targets most likely to be useful in the development of new treatments for disease

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10
Q

What is “lead identification”?

A

a lead compound or substance is one that is to be believed to have potential to treat disease

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11
Q

What is “Lead optimization”?

A

compares the properties of various lead compounds
-provides info to help biopharm companies select the compound or compounds with greatest potential

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12
Q

What are the drug development steps?

A
  1. Preclinical testing
  2. Investigational New Drug Application
  3. Clinical Trials
  4. New Drug Application
  5. Approval
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13
Q

What does “preclinical testing” involve?

A

compound is tested for safety and efficacy in lab and animal studies

  • involves:
    1. Pharmacology
    2. toxicology
    3. preformulation
    4. formulation
    5. Analytical
    6. Pharmacokinetics
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14
Q

What is “pharmacology” of preclinical testing?

A

determines the effect of the candidate drug on the body

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15
Q

What is “toxicology” of preclinical testing?

A

seek potential risks to humans
either select or reject lead candidate
dose selection and guidance

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16
Q

What are the toxicology studies that are done (x6) ?

A
  1. Acute
  2. Repeated dose
  3. Genetic
  4. Reproductive
  5. Carcinogenicity
  6. Toxicokinetic
17
Q

What is “preformulation” of preclinical testing?

A

application of biopharm principles to the physiochemical parameters of a drug with the goal of designing an optimum drug delivery system

CHARACTERIZE THE DRUG MOLECULE

18
Q

What is “formulation” of preclinical testing?

A

starts after preformulation
dependent on form

19
Q

What is the “analyitical” of preclinical testing?

A

making sure that things from tests you found are REAL

20
Q

What is pharmacokinetics of preclinical testing?

A

looking at the ADME of drug

21
Q

What does IDA consists of?

A

where you file with the FDA to begin testing drug on people after the preclinical testing

22
Q

How many phases are there in clinical trials?

A

4

23
Q

What does Phase 1 of clinical trials consist of?

A
  • determine the safety of new drug + safe dose range
  • 3-6 months
  • use healthy volunteers
  • to determine the metabolic and pharmacologic action of the drugs in humans
  • see the side effects associated with different doses
24
Q

What does Phase 2 of clinical trials consist of ?

A
  • assesses drug effectiveness
  • 6 months to 2 years
25
Q

What does Phase 3 of clinical trials consist of?

A

determines efficacy
identifies adverse reactions in large populations

26
Q

What does Phase 4 of clinical trials consist of?

A
  • only occurs if FDA wants some more trials after NDA
  • to identify rare adverse reactions not detected during pre-licensure studies
  • to evaluate long term effects
27
Q

What does the NDA consist of?

A

after all 3 phases of clinical trials
where company analyzes all data and files an NDA with FDA

28
Q

How long does FDA have to review NDA?

A

6 months
however usually takes 1-2 years for approval

29
Q

What does the Approval stage consist of?

A

where FDA approves NDA
- new med becomes available for physicians to perscribe!!
- company must continue to report periodic reports to FDA for quality-control
- may request additional trials to evaluate long terms effects (phase 4)

30
Q

What are Patents?

A

-for the product and the process used to make product
- last 20 years

31
Q

What is the Patent act of 1923?

A

allowed companies to apply for permission to manufacture a drug before its patent expired

  • would pay patent holder a royality
  • encouraged competition and reduced prices
32
Q

When can a generic drug be produced?

A
  • patent has expired
  • generic company certifies brand’s company’s patents are either invalid, unenforceable or will not be infringed (something wrong with original patent)
  • drugs that never held patents
  • in countries where a patent is not enforced
33
Q

What is awesome about producing generic drugs?

A

since drug may have already been tested and approved, cost of manufacturing will be a fraction of orignial cost of testing and developing drug

OVEERALL–> CHEAPER PROCESS TO MAKE IT (helps recover cost)

34
Q

Who in Canada reviews drugs?

A

Health Canada –> assesses safety, quality, and efficacy

name of canadian federal authority = Therapeutic Products Directorate (TPD)

HSS3106 - Pharmacology (18 decks)

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