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PharmSci Exam 1 > Lecture 1: Drug Overview > Flashcards

Lecture 1: Drug Overview Flashcards

1
Q

What was important for human-based screening?

A

Medicinal plants

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2
Q

What was important for animal-based screening?

A

Anesthetics

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3
Q

What was important for bacteria-based screening?

A

Penicillin

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4
Q

What was important for tissue-based screening?

A

G protein-coupled receptor

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5
Q

What was important for target-based screening?

A

High throughput screening

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6
Q

What was important for mechanism/structure based?

A

HIV

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7
Q

What was important for molecular and cellular based?

A

Kinase inhibitors

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8
Q

What was important for genomics based patient profiling?

A

MiRNA profiling and RNA sequencing

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9
Q

What are the steps to modern drug discovery?

A
  1. Disease pathology and target
  2. Target identification
  3. Assay development
  4. Hit to lead compounds
  5. Lead optimization
  6. Preclinical development
  7. Clinical trials
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10
Q

What are four methods of drug discovery?

A
  • random untargeted screening
  • high-throughput screening
  • molecular modification of known agents
  • mechanism-based drug design
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11
Q

What are different sources of a new therapeutic molecule?

A
  • extraction from plants
  • organic synthesis
  • animals
  • genetic engineering
  • gene and cell therapy
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12
Q

What is the purpose of gene therapy?

A

To synthesize a protein inside the body

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13
Q

What is antisense therapy?

A

When you do not want the protein in gene therapy, so you want to inhibit it

Can block transcription, translation or inactivate the protein

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14
Q

What does BLAs stand for?

A

Biologics License Application

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15
Q

What does CBER stand for?

A

Center for Biologics Evaluation and Research

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16
Q

Where is the BLAs submitted to?

A

CBER for manufacturing of biologics such as blood and blood components used for infusion or derived pharmaceutical products such as clotting factors

Vaccines or toxins

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17
Q

What is part of preclinical testing?

A

Chemical and biological characterization

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18
Q

What is part of chemical characterization of preclinical testing?

A 
Structure
Synthesis
Purity
Isomers
PKa
Stability
Solubility
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19
Q

What is part of the biological characterization of preclinical testing?

A

Acute pharmacological profile (LD50, ED50)
Receptor binding
Dose-effect relationships
Tests for different activities

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20
Q

What is the therapeutic index calculation?

A

Lethal dose in 50% of subjects (LD50) / Effective dose in 50% subjects (ED 50)

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21
Q

What is the ADME/Tox?

A 
Absorption
Distribution
Metabolism
Excretion
Toxicology prediction
22
Q

What is important during preclinical testing?

A

Safety and toxicity in animals

23
Q

What profiles are part of the safety and toxicity in animals?

A
  • acute toxicity profile
  • chronic toxicity profile
  • toxicity test in rodents and non-rodents before humans
  • toxicity at dose levels below, about, well above human dose
24
Q

What aspect of pharmacy is important during preclinical testing?

A

Pharmacokinetics and pharmacodynamics

25
Q

Before the drug is created, what must be done?

A

Pre-formulation studies

26
Q

What is the purpose of pre-formulation studies?

A

To define the physical and chemical properties of the agent

27
Q

What is key to consider before formulation of the drug?

A

The drug solubility and pH

28
Q

What are commonly used approaches to increase the drug solubility and pH?

A
  • make salts
  • make esters
  • form chemical complexation
  • reduce particle size in drugs
29
Q

What does increasing the drug’s solubility do?

A

Increase the absorption

30
Q

What is the difference between a crystal vs amorphous form ?

A

Crystals are less soluble

31
Q

What does a reduction in particle size do to the drug?

A

Increases the surface area

Increases the drug’s dissolution rate and absorption

32
Q

What happens for drugs that are susceptible to oxidative decomposition?

A

Degrade, so then need to add an antioxidant

33
Q

What happens to drugs that are destroyed by hydrolysis?

A

Cannot add by injection

Need to be reconstituted right before injection because they are unstable in water

34
Q

What do you check during the pre-formulation studies?

A
  • drug solubility and pH
  • partition coefficient
  • physical forms
  • particle size
  • stability
35
Q

What does a drug’s partition coefficient indicate?

A

Its ability to penetrate biological membranes

36
Q

What factors are integral to clinical trials?

A 
Physicochemical properties of a drug
Dosage forms
Route of administration
Patient condition, age, gender, disease status
Concomitant drug therapy
37
Q

What does safe and effective dose of a drug depend on?

A 
Physiocochemical properties of a drug
Dosage forms
Route of administration
Patient condition, age, gender, disease status
Concomitant drug therapy
38
Q

What dose FDA stand for?

A

Food and Drug Administration

39
Q

What phase of clinical trials has healthy volunteers and has 20-100 people?

A

Phase I

40
Q

What phase of clinical trials has a small number of patients and has up to several hundreds of people?

A

Phase 2

41
Q

What phase of clinical trials has a large scale multi-centers?

A

Phase 3

42
Q

What phase of clinical trials has post marketing monitoring, several hundreds to several thousands of people?

A

Phase 4

43
Q

What dose IRB stand for?

A

Institutional Review Board

44
Q

What must occur before any clinical testing?

A

Review and approval of an IND application by IRB

45
Q

What are two important FDA centers that review an IND application?

A

CDER &CBER

46
Q

What does CDER stand for?

A

Center for Drug Evaluation and Research

47
Q

What does CBER stand for?

A

Center for Biologic Evaluation and Research

48
Q

What is a double blind trial?

A

Neither researcher nor patients know what they are getting

Computer gives each patient a code and code numbers are allocated to treatment groups

49
Q

What does SNDA stand for?

A

Supplemental New Drug Application

50
Q

What does ANDA stand for?

A

Abbreviated New Drug Application

51
Q

What are generic drugs?

A

Chemical equivalent of drugs whose patents have expired

52
Q

What does NDA stand for?

A

New Drug Application

PharmSci Exam 1 (4 decks)

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