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Pharmacology 1 > Drug Discovery and the Approval Process > Flashcards

Drug Discovery and the Approval Process Flashcards

1
Q

Estimates for drug research

A

$1.5 - $50 million

  • time: 8-15 years
  • food animal > companion animal > vaccines
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2
Q

Pharmocognosy

A

Eco-mining

  • medicinal drugs obtained from plants or other natural sources
  • ex: Pacific Yew for ovarian and breast cancer
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3
Q

Incrementally Modified Drug

A

Chemical alteration of a known molecule

- done to get rid of adverse effect and leads to an equal or improved product

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4
Q

Molecular modeling

A

Make 3D image of receptor and custom build a molecule to react with that receptor

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5
Q

New chemical entity (NCE) sources

A
  • pharmacognosy
  • incrementally modified drug
  • molecular modeling
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6
Q

How long does a patent last on a drug?

A

20 years

- can begin at any time before, during, or after actual approval by the FDA

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7
Q

What other methods of marketing exclusivity protection exists for drug manufacturers aside from
patents?

A
  • Human Orphan Drug Exclusivity - 7 years
  • New Chemical Entity Exclusivity - 5 years
  • Generating Antibiotic Incentives Now - 5 years
  • New Clinical Investigation - 3 years
  • Human Pediatric Exclusivity - 6 months added to existing patent/exclusivity
  • Patent Challenge - 180 days for first generic product
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8
Q

Human food safety measures

A
  • genetic toxicity studies
  • 90 day feeding studies in rodents and mammals
  • teratology in rats
  • antimicrobial resistance studies (put selective pressure on a surviving mutant)
  • chronic (lifetime) toxicity and/or carcinogenicity studies in rodents
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9
Q

Intent of human food safety studies is to find the ______

A

NOEL

- no observed effect level (how high you can go without having a physiologic effect)

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10
Q

ADI

A

Allowable daily intake

- ADI = (NOEL/safety factor) in Mcg/kg

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11
Q

Safety factor

A
  • variability between humans = 10X
  • interspecies extrapolation = 10-100X
  • subchronic (intermittent exposure) extrapolation = 10X
  • -> total possible = 10-10,000X (1,000X is common for food animals)
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12
Q

Allowed “tolerance”

A

How much can legally allow to exist in the tissue (anything above tolerance factor is illegal)
- safety concentration = ADI x 60 kg/consumption factor

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13
Q

Hot studies

A

Radio-labeled drug

  • easy to trace radioactivity and follow what organs the drug goes to
  • follows both parent and metabolite = total reactivity
  • carbon14 has a long half life (concern for disposal of animal)
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14
Q

Cold studies

A

Basic analytical chemistry

  • done by FDA and USDA
  • pick a target tissue based on where the highest residue ends up (depletes most slowly, is usually kidney/liver)
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15
Q

Marker residue

A

Monitors the depletion of total residues in a tissue

- can be either the parent drug or a metabolite

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16
Q

What activities typically occur during the preclinical stage of drug development?

A

Synthesis and purification

  • develop stability and analytical techniques (assay in fluids and tissues)
  • marketing review
  • scale-up
  • early pharmacokinetic studies
  • proof of safety
  • proof of efficacy (in vitro and in vivo models)
17
Q

With genetic toxicity testing, you treat all products as ______ until proven otherwise

A

Carcinogens

18
Q

At what phase does management decide if its a go/no-go?

A

Preclinical phase

19
Q

INAD

A

Investigational new (animal) drug application

  • allows legal interstate shipment of a nonapproved drug
  • FDA does not actually “approve” an INAD, just assume its approved
20
Q

IND includes preliminary _______

A
  • target animal safety and efficacy data
  • environmental safety data (feces from food animals)
  • human food safety data
  • sets the conditions upon which animals treated with such articles, and any animal products, may be marketed for drug use
21
Q

IND applies to the ______

A

New formulation

22
Q

A NME is never ______

A

Approved as a drug

- each formulation of NME, pioneer and generic, receives separate approval

23
Q

NADA

A

New animal drug application

- approval by FDA, submissions performed electronically

24
Q

ANADA

A

Abbreviated new animal drug approval number

  • given to approved generic drugs
  • copy an already approved new animal drug (active ingredient, strength, dosage, route of admin)
25
Q

Technical sections of ANADA

A
  • bioequivalence to reference (pioneer) product –> not safety and effectiveness!
  • chemistry, manufacturing, controls
  • environmental impact
  • human food safety
  • labeling
  • still needs FOI
26
Q

What multiples of dose are typically studied in a target animal margin of safety study?

A

1x, 3x, 5x dose

- kinetic studies to address linearity (dose proportionality), ADME during full development phase

27
Q

What is meant by the term “pioneer” drug product?

A

Original formulation, first drug patented
- generic is a copy of the pioneer drug, has to be absorbed in approximately the same amount and rate as the pioneer drug

28
Q

Intent of a phase 1 clinical trial

A
  • primary: kinetics and set dose
  • secondary: safety
  • tertiary: efficacy
29
Q

Intent of a phase 2 clinical trial

A
  • primary: efficacy (final dose selection)
  • secondary: safety
  • tertiary: kinetics (subpopulations, such as liver or kidney disease patients)
  • -> phase where informed consent begins in vet med
30
Q

Intent of a phase 3 clinical trial

A

Verify effectiveness

  • dose confirmation trials: conducted in target animal using formulation, dosage, and route of admin to be marketed
  • monitor adverse reactions from long-term use
31
Q

What is the intent of Phase 4 testing and/or post‐marketing surveillance?

A

Picks up low-incidence adverse reactions or public health consequences

  • mandatory reporting
  • ex: national antimicrobial resistance monitoring system
32
Q

What is a positive control versus a negative control as it relates to a drug clinical trial?

A
  • positive control: comparing test substance against an already approved drug (trying to see if new drug is as good, or not effective as the original)
  • negative control: placebo
33
Q

Single masked study

A

Patient doesn’t know treatment, clinician does

- rare

34
Q

Double masked study

A

Neither patient nor clinician knows the treatment identity

  • if extreme effect occurs, the external Data and Safety Monitoring Board can recommend either early termination or design alteration
  • standard, want to eliminate placebo effect (can be up to 50%)

Pharmacology 1 (15 decks)

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