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PharmSci Exam 1 > Lecture 1: Drug Overview > Flashcards

Lecture 1: Drug Overview Flashcards

(52 cards)

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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?

Study These Flashcards
A 
Absorption
Distribution
Metabolism
Excretion
Toxicology prediction
22
Q

What is important during preclinical testing?

Study These Flashcards
A

Safety and toxicity in animals

23
Q

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

Study These Flashcards
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?

Study These Flashcards
A

Pharmacokinetics and pharmacodynamics

25
Before the drug is created, what must be done?
Pre-formulation studies
26
What is the purpose of pre-formulation studies?
To define the physical and chemical properties of the agent
27
What is key to consider before formulation of the drug?
The drug solubility and pH
28
What are commonly used approaches to increase the drug solubility and pH?
- make salts - make esters - form chemical complexation - reduce particle size in drugs
29
What does increasing the drug's solubility do?
Increase the absorption
30
What is the difference between a crystal vs amorphous form ?
Crystals are less soluble
31
What does a reduction in particle size do to the drug?
Increases the surface area | Increases the drug's dissolution rate and absorption
32
What happens for drugs that are susceptible to oxidative decomposition?
Degrade, so then need to add an antioxidant
33
What happens to drugs that are destroyed by hydrolysis?
Cannot add by injection Need to be reconstituted right before injection because they are unstable in water
34
What do you check during the pre-formulation studies?
- drug solubility and pH - partition coefficient - physical forms - particle size - stability
35
What does a drug's partition coefficient indicate?
Its ability to penetrate biological membranes
36
What factors are integral to clinical trials?
``` Physicochemical properties of a drug Dosage forms Route of administration Patient condition, age, gender, disease status Concomitant drug therapy ```
37
What does safe and effective dose of a drug depend on?
``` Physiocochemical properties of a drug Dosage forms Route of administration Patient condition, age, gender, disease status Concomitant drug therapy ```
38
What dose FDA stand for?
Food and Drug Administration
39
What phase of clinical trials has healthy volunteers and has 20-100 people?
Phase I
40
What phase of clinical trials has a small number of patients and has up to several hundreds of people?
Phase 2
41
What phase of clinical trials has a large scale multi-centers?
Phase 3
42
What phase of clinical trials has post marketing monitoring, several hundreds to several thousands of people?
Phase 4
43
What dose IRB stand for?
Institutional Review Board
44
What must occur before any clinical testing?
Review and approval of an IND application by IRB
45
What are two important FDA centers that review an IND application?
CDER &CBER
46
What does CDER stand for?
Center for Drug Evaluation and Research
47
What does CBER stand for?
Center for Biologic Evaluation and Research
48
What is a double blind trial?
Neither researcher nor patients know what they are getting Computer gives each patient a code and code numbers are allocated to treatment groups
49
What does SNDA stand for?
Supplemental New Drug Application
50
What does ANDA stand for?
Abbreviated New Drug Application
51
What are generic drugs?
Chemical equivalent of drugs whose patents have expired
52
What does NDA stand for?
New Drug Application

PharmSci Exam 1 (4 decks)

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