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Pharm Sci > 1.1 Drug Discover, Development & Regulatory Processes Objectives > Flashcards

1.1 Drug Discover, Development & Regulatory Processes Objectives Flashcards

1
Q

Edward Jenner

A
  • 1796
  • Paved the way for modern vaccines against infectious diseases
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2
Q

William Withering

A
  • 1700
  • Introduced digitalis (treat cardiovascular disease)
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3
Q

John Hunter

A
  • 1768
  • Vitamin C deficiency leads to scurvy
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4
Q

Louis Pasteur

A
  • 1864
  • Discovered microorganisms caused disease & devised a vaccine against rabies
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5
Q

Recombinant DNA (rDNA)

A
  • 1970
  • rDNA production —> biotechnology industry
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6
Q

Different types of modern drug discovery

A
  1. Human based screening
  2. Animal-based screening
  3. Bacteria-based screening
  4. Tissue-based screening
  5. Mechanisms/Structure-based
  6. Molecular & cell based
  7. Genomics-based patient profiling
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7
Q

Human based screening

A

Medicinal plants

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8
Q

Animal-based screening

A

Anesthetics

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9
Q

Bacteria-based screening

A

Penicillin

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10
Q

Tissue-based screening

A

G protein-coupled receptor

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11
Q

Mechanisms/Structure-based

A

HIV

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12
Q

Molecular & cell based

A

Kinase inhibitors

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13
Q

Genomics-based patient profiling

A

miRNA profiling, RNA sequencing—>RNA therapeutics, gene medicine, coronavirus vaccine

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14
Q

List the # of steps involved in drug discovery & development

A
  1. Disease pathology & molecular targets
  2. Target identification
  3. Assay development
  4. Hit to lead compounds
  5. Lead Optimization
  6. Preclinical development
  7. Clinical trials
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15
Q

Disease pathology & molecular target

A

The research that needs to be done to understand the condition

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16
Q

Target identification

A

“ID area” in a molecule to target the disease

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17
Q

Assay development

A

In vitro study to understand the effect on the target ID

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18
Q

Hit to lead compounds

A

Narrow down to most effective candidate in vitro

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19
Q

Preclinical development

A

Animal trials

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20
Q

Clinical trials

A

Human trials

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21
Q

What causes diseases?

A
  1. Bacterial infection
  2. Host imbalance
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22
Q

Host imbalance

A
  1. Inhibit overactive proteins
    - kinase inhibitors
  2. Replace/substitute underactive protein
    - insulin
  3. Identify gene causing the disease
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23
Q

What are the methods of drug discovery?

A
  1. Random untargeted screening
  2. High-throughput screening
  3. Molecular modification of known agents
  4. Mechanism-based drug design
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24
Q

Random untargeted screening

A

ID the unknown compounds in a sample (w/o the aid of any initial additional informations)

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25
Q

High-throughput screening

A

Rapidly testing thousands to millions of samples for biological activity in organism, cellular, pathway or molecular level

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26
Q

Molecular modification of known agents

A

Chemical modification of a previously characterized compound for the purpose of enhancing its usefulness as a drug

27
Q

What is the Biologics behind the drug development process?

A
  1. Recombinant DNA technology
  2. mAb (monoclonal antibody)
  3. Gene therapy
  4. Antisense Therapy
  5. BLA
28
Q

Recombinant DNA technology

A
  1. Produce variety of proteins
  2. Protein production within cells of lower animals
    - Human insulin, human growth hormones, interferon
29
Q

mAb (Monoclonal antibody)

A
  1. Produce Ab—>stimulate patient’s immune system to attack those cells
  2. Ab production occurs within higher animals
    - Treat cancer, Alzheimer’s, rheumatoid arthritis
30
Q

Gene therapy

A
  1. Prevent, treat, cure, human disease caused by genetic disorders
  2. Transcription of normal genes into cells to replace missing, defected ones in order to correct genetic disorders
31
Q

Antisense Therapy

A
  1. Sections of NAs bind to specific mRNA by blocking cell’s ability to use RNA to make a translate or inhibit catalytic fxn of other RNA
    - Prevent harmful proteins, mutate the function to block it
32
Q

BLA

A
  1. Submitted to CBER manufacture
    - Blood & blood components
    —> Infusion, clotting factors
    - Vaccines
    —> Measles, polio
    - Toxins
    —> Shinga toxin, seafood toxin
33
Q

Preclinical testing

A
  1. Chemical
    - Structure, synthesis, purity, pKa, stability & solubility
  2. Biological
    - Therapeutic Index = LD50/ED50
34
Q

How to increase water solubility in drugs?

A
  1. Salt or esters
  2. Partition coefficient
  3. Physical forms
  4. Particle size
  5. Stability
35
Q

Salter or esters

A
  1. Increase surface area = increase solubility
36
Q

Partition coefficient

A

Indicates its ability to penetrate biological membranes

37
Q

Physical forms

A
  1. Crystal, amorphous or polymorphic
  2. Amorphous most soluble
38
Q

Particle size

A

Decrease particle size = Increase surface area = increase dissolution rate

39
Q

Stability

A
  1. Susceptible to oxidative decomposition
  2. Drug destroyed by hydrolysis
40
Q

What will affect the safety and efficacy of drug dosage?

A
  1. Physiochemical properties of a drug
  2. Dosage forms
  3. Route of administration
  4. Patient condition, age, gender, disease status
  5. Concomitant drug therapy
41
Q

What does FDA regulate?

A
  1. Drugs
  2. Biologics
  3. Medical devices
  4. Food
  5. Animal feed & drugs
  6. Cosmetics
  7. Electromagnetic radiation
42
Q

Drugs

A

OTC, prescription

43
Q

Biologics

A

Vaccines, blood products

44
Q

Medical devices

A

Pacemakers, Contact lenses

45
Q

Food

A

Nutrition, supplements

46
Q

Animal feed & drugs

A

Livestock & pets

47
Q

Cosmetics

A

Safety & labeling

48
Q

Electromagnetic radiation

A

Cell phones & lasers

49
Q

Differentiate b/t an IND application & a NDA

A

IND = occurs prior to clinical trials
NDA = Occurs after phase III clinical trials

50
Q

ADME

A

Tested in vivo preclinical testing
1. Absorption
- Drug transfer from site to blood
2. Distribution
- From the blood/lymphatic system to site of action
3. Metabolism
- Transformation from one drug to another, via kidney, liver
4. Excretion
- Removal of the drug out of the body, via urine or other bodily fluids

51
Q

IRB

A

Group reviews & monitor biomedical research in human subjects

52
Q

CBER

A

Within FDA, regulate biologic products for human use under federal law

53
Q

CDER

A
  • Within FDA, oversees R&D & manufacturing of all small MW drugs and biological therapeutic agents
  • Begin with Phase I via approval of the IND application
54
Q

SNDA

A
  • Improve the drug post- Phase III
  • Change synthesis methods, manufacturing facility
55
Q

ANDA

A

Creating a generic that is interchangeable/therapeutic equivalent to the brand

56
Q

Different phases of clinical trials?

A

Phase I - Phase IV

57
Q

Phase I

A
  1. Healthy volunteers 20-100 pts
  2. ID metabolic & excretory pathway & effect of route on bioavailability
  3. ID tolerated dose range, therapeutic effects, side effects
58
Q

Phase II

A
  1. Small # up to several hundreds (135-350 pts)
  2. Max monitoring, pts whom other treatments failed & dose range depends on pt and severity of disease
  3. Pharmacokinetic studies in pts, side effects & severity, effects in special groups
59
Q

Phase III

A
  1. Large scale, 1500-3000 pts
  2. Certain data on efficacy & toxicity, Drug-drug interactions
  3. Sub-group is ID & problems start to show up
60
Q

Phase IV

A
  1. Post marketing monitoring several hundred to several thousands
  2. Studies serious/unexpected adverse effects & modify for efficacy
61
Q

What is a Double Blind trial?

A

Trial where neither the researches nor pt. Know what they are getting

62
Q

What are the CFR requirements for product labeling?

A
  1. Package insert
  2. Company literature
  3. Advertising
63
Q

When is SNDA needed?

A
  1. Change in method of synthesis
  2. Change of manufacture
  3. Change in formulation
  4. Minor changes
64
Q

What is a generic drug = ANDA process?

A
  1. Chemically equivalent drugs whose patents have expired
  2. Must = to approved drug in term of bioavailability (no clinical trials are needed)

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