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

1.1 Drug Discover, Development & Regulatory Processes Objectives Flashcards

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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
High-throughput screening
Rapidly testing thousands to millions of samples for biological activity in organism, cellular, pathway or molecular level
26
Molecular modification of known agents
Chemical modification of a previously characterized compound for the purpose of enhancing its usefulness as a drug
27
What is the Biologics behind the drug development process?
1. Recombinant DNA technology 2. mAb (monoclonal antibody) 3. Gene therapy 4. Antisense Therapy 5. BLA
28
Recombinant DNA technology
1. Produce variety of proteins 2. Protein production within cells of lower animals - Human insulin, human growth hormones, interferon
29
mAb (Monoclonal antibody)
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
Gene therapy
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
Antisense Therapy
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
BLA
1. Submitted to CBER manufacture - Blood & blood components —> Infusion, clotting factors - Vaccines —> Measles, polio - Toxins —> Shinga toxin, seafood toxin
33
Preclinical testing
1. Chemical - Structure, synthesis, purity, pKa, stability & solubility 2. Biological - Therapeutic Index = LD50/ED50
34
How to increase water solubility in drugs?
1. Salt or esters 2. Partition coefficient 3. Physical forms 4. Particle size 5. Stability
35
Salter or esters
1. Increase surface area = increase solubility
36
Partition coefficient
Indicates its ability to penetrate biological membranes
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Physical forms
1. Crystal, amorphous or polymorphic 2. Amorphous most soluble
38
Particle size
Decrease particle size = Increase surface area = increase dissolution rate
39
Stability
1. Susceptible to oxidative decomposition 2. Drug destroyed by hydrolysis
40
What will affect the safety and efficacy of drug dosage?
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
What does FDA regulate?
1. Drugs 2. Biologics 3. Medical devices 4. Food 5. Animal feed & drugs 6. Cosmetics 7. Electromagnetic radiation
42
Drugs
OTC, prescription
43
Biologics
Vaccines, blood products
44
Medical devices
Pacemakers, Contact lenses
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Food
Nutrition, supplements
46
Animal feed & drugs
Livestock & pets
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Cosmetics
Safety & labeling
48
Electromagnetic radiation
Cell phones & lasers
49
Differentiate b/t an IND application & a NDA
IND = occurs prior to clinical trials NDA = Occurs after phase III clinical trials
50
ADME
*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
IRB
Group reviews & monitor biomedical research in human subjects
52
CBER
Within FDA, regulate biologic products for human use under federal law
53
CDER
- 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
SNDA
- Improve the drug post- Phase III - Change synthesis methods, manufacturing facility
55
ANDA
Creating a generic that is interchangeable/therapeutic equivalent to the brand
56
Different phases of clinical trials?
Phase I - Phase IV
57
Phase I
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
Phase II
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
Phase III
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
Phase IV
1. Post marketing monitoring several hundred to several thousands 2. Studies serious/unexpected adverse effects & modify for efficacy
61
What is a Double Blind trial?
Trial where neither the researches nor pt. Know what they are getting
62
What are the CFR requirements for product labeling?
1. Package insert 2. Company literature 3. Advertising
63
When is SNDA needed?
1. Change in method of synthesis 2. Change of manufacture 3. Change in formulation 4. Minor changes
64
What is a generic drug = ANDA process?
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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