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Question 1
How long does it typically take to develop a drug from target identification to approval?
>10 years
Question 2
What are the stages of drug development?
1. drug discovery 2. preclinical research 3. IND app 4. Clinical trials (SEAL)
Question 3
What are the two stages of drug discovery?
Pre-discovery: uncover disease mechanisms and possible targets Discovery stage: search for molecules to inhibit disease mechanism
Question 4
What is the final aim of drug discovery?
Identify lead compounds.
Question 5
What is the purpose of preclinical research in drug development?
• test efficacy and safety of lead compounds • in cell culture and small animal studies
Question 6
What are the steps involved in preclinical research?
• Confirm drug mechanism of action and efficacy • construct dose-response curves • evaluate toxicity and lethal doses • assess carcinogenic and teratogenic effects • confirm the best route of administration
Question 7
What is the purpose of an IND application?
To submit data to the FDA for review before clinical trials can start.
Question 8
What data does an IND application include?
• Animal efficacy data • toxicity data • dosing schedule • administration protocol • intended use
Question 9
What is the purpose of Phase I clinical trials?
SAFETY
• Safety testing in healthy volunteers • 20-80 people
Question 10
What is the purpose of Phase II clinical trials?
EFFICACY
• small group of patients, 100s • placebo is also given
Question 11
What is the purpose of Phase III clinical trials?
APPROVAL
• Efficacy and safety testing in a large group of patients • 1000s • can test dosages and combos with other drugs
Question 12
What happens at the end of Phase III trials?
Data are submitted to the FDA as a New Drug Application (NDA).
Question 13
What is phase IV of clinical trials
LONG TERM
• after FDA approves • post marketing surveillance • continue to track unidentified or delayed effects
Question 14
What is the FDA's MedWatch system?
A voluntary system for reporting adverse events
Question 15
What is the United States Pharmacopeia (USP)?
An independent, scientific, and nonprofit organization founded in 1820.
Question 16
USP Function
Set standards for medications and dietary supplements (like, purity, strength, manufacturing quality)
Question 17
What is the significance of the USP standards for medications in the USA?
Medications in the USA follow the USP standards.
Question 18
What is the Food and Drug Administration (FDA) responsible for?
enforce standards set by USP
Question 19
What is the Drug Enforcement Administration (DEA) responsible for?
enforces controlled substance laws and regulations
Question 20
What must healthcare providers do to prescribe controlled substances?
must be registered with the DEA and include the DEA number in each controlled substance prescription
Question 21
How many classes does the Controlled Substances Act categorize drugs into?
Five
Question 22
What are Schedule I drugs?
Highest potential for abuse and
no medical use
Question 23
examples of schedule I drugs
heroin, LSD, and marijuana
Question 24
What are Schedule II drugs?
High potential for abuse leading to extreme psychological or physical dependence
Question 25
Examples of schedule II drugs
morphine, codeine, and fentanyl
Question 26
What are Schedule III drugs?
moderate to low potential for physical and psychological dependence
Question 27
What are some examples of Schedule III drugs?
Drugs containing less than 90 milligrams of codeine, barbiturates, and ketamine
Question 28
What are Schedule IV drugs?
Low potential for abuse and low risk of dependence
Question 29
examples of schedule IV drugs
benzodiazepine sedatives, antianxiety, and antidepressants
Question 30
what are schedule V drugs
lowest potential for abuse; cough syrups
Question 31
What are the types of drug categories
• conventional • protein based - biologics • oligonucleotide therapies • cell and gene therapies
Question 32
What are conventional drugs?
meds with defined chemical structure that are chemically synthesized
Question 33
Types of conventional drugs
prescription and over the counter
Question 34
What are biologics/biosimilars?
meds made in living cells • hormones, therapeutic antibodies, vaccines, growth factors, via the parenteral route
Question 35
What are antisense oligonucleotides and siRNA?
Short chain nucleic acids that can alter gene expression, via the parenteral route.
Question 36
What is gene therapy?
Repairing a faulty gene via viral vectors and others.
Question 37
What is the definition of a chemical name in drug nomenclature?
A chemical name describes the chemical structure of a drug.
Question 38
What is the purpose of a generic name in drug nomenclature?
A generic name is a shortened version of the chemical name used by health professionals.
Question 39
What is the purpose of a brand/trade name in drug nomenclature?
A brand/trade name is given by pharmaceutical companies that make the medication.
Question 40
What is the purpose of an Abbreviated New Drug Application (ANDA)?
To approve a generic drug that is bioequivalent to the brand-name version.
Question 41
What must manufacturers submit to demonstrate bioequivalence for a generic drug?
Data showing the same active ingredient(s) with the same strength, dosage form, route of administration, indications, and absorption.
Question 42
What is the intended action of a drug?
A therapeutic effect
Question 43
What are side effects?
Mild effects that can vary in intensity among individuals.
Question 44
What is an adverse drug reaction?
A more severe reaction
Question 45
What is pharmacokinetics?
How
drugs get into our body
including absorption and elimination
Question 46
What is pharmacodynamics
What
medications do to our body
focusing on individual differences in drug response.
Question 47
what is pharmacotherapeutics
“Indication for drug use”
Question 48
What is pharmacogenomics?
how genetic variations influence drug response and optimal dose
Question 49
What is the first pharmacokinetic phase?
Drug Absorption
Question 50
What is the second pharmacokinetic phase?
Drug Distribution
Question 51
What is the third pharmacokinetic phase?
Drug Metabolism
Question 52
What is the fourth pharmacokinetic phase?
Drug Excretion
Question 53
What are absorption and distribution in drug movement?
movement of drug from site of admin to systemic circulation and to tissues/organisms
Question 54
what are the major routes of elimination
hepatic metabolism biliary elimination urinary excretion
Question 55
What is drug absorption?
drug → site of administration → systemic circulation
Question 56
What are the drug-associated factors that influence absorption?
Chemical structure, solubility, dosage form, and formulation of the drug.
Question 57
What are the patient-associated factors that influence absorption?
Route of administration, blood flow to the absorption site, pH at the injection site, disease state, and the biological membranes to overcome.
Question 58
What is bioavailability?
- fraction of a drug that is absorbed into the systemic circulation - available to exert its pharmacological effect
Question 59
How is bioavailability calculated?
AUC oral / AUC IV x 100
Question 60
What are the factors affecting bioavailability?
First-pass metabolism, ionization state and chemical instability, total surface area available for absorption, blood flow to the absorption site, and nature of the drug.
Question 61
Why do very lipophilic drugs have poor bioavailability?
Because they are insoluble in aqueous body fluids.
Question 62
why are very hydrophilic drugs poorly absorbed
they can not maneuver lipid-rich cell membranes
Question 63
What is the difference between intravenous (IV) and intramuscular (IM) injections?
IV: directly into the bloodstream IM: inject medication into the muscle tissue
Question 64
What are the two main categories of drug administration routes?
Local and Systemic
Question 65
What does the term 'Local' refer to in the context of drug administration?
Routes that deliver drugs directly to a specific site without entering the bloodstream.
Question 66
What are the subcategories of the 'Local' route?
Topical, ocular, intrathecal route
Question 67
types of enteral drugs
via GI oral, sublingual, rectal
Question 68
What are the factors governing the route of choice in drug administration?
Drug stability, pharmacokinetic profile, clinical settings, and patient's condition.
Question 69
What does the pharmacokinetic profile include?
Impact of metabolism (GI and Liver), required site of action, and required onset of action.
Question 70
What are the advantages of parenteral administration?
Direct delivery to the bloodstream, rapid onset of action, and bypasses the first-pass effect.
Question 71
What are the disadvantages of parenteral administration?
Painful injections, risk of infection, and potential for extravasation.
Question 72
What are the advantages of oral administration?
Convenient, non-invasive, and can be self-administered.
Question 73
What are the disadvantages of oral administration?
Potential for first-pass metabolism, slower onset of action, and variable absorption.
Question 74
What are the advantages of sublingual/buccal administration?
Rapid absorption, avoids first-pass metabolism, and can be self-administered.
Question 75
What are the disadvantages of sublingual/buccal administration?
Potential for rapid degradation, limited drug stability, and variable absorption.
Question 76
What are parenteral drugs?
Parenteral drugs are medications that are administered directly into the body, bypassing the digestive system.
Question 77
four types of parenteral drug administration
Intravenous injection subcutaneous injection intramuscular injection dermal injection
Question 78
What is the bioavailability of intravenous drugs?
Almost 100%
Question 79
What are the advantages of intravenous drug administration?
Immediate effect, no absorption required, suitable for drugs that can/can't be absorbed orally.
Question 80
What is the absorption rate of intramuscular injections?
Relatively rapid due to high vascularity (5-20 min)
Question 81
What are the disadvantages of intramuscular injections?
Injection site pain, possibility of hematoma, abscess, nerve injury
Question 82
What are the advantages of subcutaneous injections?
Slower onset and smaller injection volumes, suitable for aqueous and depot, patient can self-administer
Question 83
What is the advantage of sublingual administration?
Convenience and ease of administration, rapid absorption, bypass of GI enzymes and liver metabolism.
Question 84
What is the most common route of drug administration?
Oral administration
Question 85
Where do oral drugs undergo dissolution and absorption?
Stomach or intestine
Question 86
What is the purpose of enteric coated capsules?
To delay the release and absorption of drugs until they reach the alkaline environment of the intestine
Question 87
What is the primary site of drug absorption in the body?
The intestine
Question 88
What is passive diffusion?
movement from a high concentration → low concentration without the need for energy
Question 89
What is facilitated diffusion?
movement of molecules across a cell membrane with the help of carrier proteins requiring no energy
Question 90
How does active transport differ from facilitated diffusion?
Active transport requires energy and can get saturated or inhibited
Question 91
What is endocytosis
engulfment of large molecules by endocytic vesicles,
Question 92
What is first-pass metabolism?
The hepatic metabolism of drugs following absorption from the GI tract
Question 93
Where does first-pass metabolism occur?
In the liver