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PHRM 828 Exam 1 > Byrn Lecture 2 > Flashcards

Byrn Lecture 2 Flashcards

1
Q

Challenges of Drug Development

A

Short time line (such as pandemics)
Broad Dose Range (warfarin has low dose range)
Minimal Amounts of API

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2
Q

Strategies to these Challenges

A

Knowledge-based decision making
Prepare in small scale
Determine performance often
Plan for manufacture

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3
Q

Methods of Drug Discovery

A

Screening
Molecular Modification of known agents

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4
Q

Big Questions that need Answered

A

What is structure of compound?

What is the likely dose?

What is the route of administration?

What is indication?

How difficult to make?

How soluble is compound?

How well is it absorbed?

What is the toxicology?

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5
Q

Beta Blocker Modification

A

Dicholorisoproterenol (1958) –> Pronethalol (1962) –> Propranolol (1964)

Process is called drug design by modifying and altering preexisting drugs

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6
Q

Initial Formulation

A

can begin with a powder

tested only on 10 patients

must be reproducible and knowledgeable

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7
Q

Investigational New Drug Application

A
  • application to get approval from the government
  • FDA approves the trial and will then approve
  • contains clinical study controls and designs
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8
Q

New Drug Application

A
  • if drug is safe and effective, the company submits a NDA as a formal request to FDA to approve for marketing
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9
Q

NDA Content

A
  • drug product labeling
  • FDA review
  • Phase 4 studies
  • Postmarketing surveillance
  • Annual reports
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10
Q

Abbreviated New Drug Application

A

generic drug application

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11
Q

Biologics License Application

A

vaccines and antibody application

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12
Q

ADME

A

Absorption
Distribution
Metabolism
Excretion

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13
Q

Acute Toxicity Studies

A

give the drug directly to animal to test toxicity

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14
Q

Subacute Studies

A

fractions of dosages to volunteers to examine toxicity and effects

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15
Q

Pharmacology

A

science concerned with drugs, their sources, appearance, chemistry, actions, and uses

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16
Q

Preformulation Studies

A

physical and chemical studies to understand properties of drugs

17
Q

Partition Coefficient

A

drug must pass the biological membrane of the lipid or protein

understands the lipophilic:hydrophilic distribution

18
Q

Drug Solubility

A
  • necessary for absorption and transport
  • must contain at least 10mg/ml to provide a minimal response
  • can be altered by structure or particle size
19
Q

Dissolution Rate

A
  • speed or rate at which a substance dissolves
  • In 1 to 2 days, the drug will go out through the feces
20
Q

Physical Form

A
  • crystalline vs amorphous vs liquids
  • account for the particle size in determining solubility
21
Q

Stability

A
  • must have drugs that don’t degrade through time, radiation, altitude
  • stay whole through different hydrolysis and heat
22
Q

Clinical Protocol

A

ensures the appropriate design and conduct of the investigation

23
Q

Phase 1 of Clinical Trial

A
  • 1st in human
  • determine pharmacology of drug, SAR relationship, side effects of dose increases

PURPOSE: mainly safety

24
Q

Phase 2 of Clinical Trial

A
  • clinical study of effectiveness in patients with the condition
  • dosage selection is made

PURPOSE: effectiveness

25
Q

Phase 3 of Clinical Trial

A
  • testing on several 100 controlled and uncontrolled trials

PURPOSE: all things considered

26
Q

Crossover in Trials

A

A: assigned drug

B: assigned placebo

After a month, it is switched and compared

27
Q

Annual Reports of Drugs

A
  • must be completed for each approved drug
  • annual summary of the significant new information (safety, effectiveness, labeling)
28
Q

Abbreviated New Drug Application

A
  • nonclinical laboratory studies and clinical investigations may be omitted
  • must still contain studies pertaining to drug’s bioavailability and generic drug products

PHRM 828 Exam 1 (5 decks)

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