What is the FDA review and registration phase in drug development?
Show answer
The phase where the FDA evaluates the safety and efficacy of a drug before it can be approved for market.
11
What is the hit rate in drug discovery and development?
Show answer
The probability of a drug candidate successfully progressing through the development process.
12
How long does it typically take to develop a drug from target identification to approval?
Show answer
>10 years
13
What is the final aim of drug discovery?
Show answer
Identify lead compounds.
14
What are the two stages of drug discovery?
Show answer
Pre-discovery and discovery stage.
15
What is the purpose of the pre-discovery stage in drug discovery?
Show answer
To uncover disease mechanisms and possible targets.
16
What is the purpose of preclinical research in drug development?
Show answer
To test the efficacy and safety of lead compounds in cell culture and small animal studies.
17
What are the steps involved in preclinical research?
Show answer
Confirm drug mechanism of action and efficacy, construct dose-response curves, evaluate toxicity and lethal doses, assess carcinogenic and teratogenic effects, and confirm the best route of administration.
18
What is the purpose of an IND application?
Show answer
To submit data to the FDA for review before clinical trials can start.
Efficacy and safety testing in a large group of patients
24
What is a Randomized Controlled Clinical Trial (RCT)?
Show answer
An RCT is a type of clinical trial where participants are randomly assigned to either a test group receiving the experimental drug or a control group receiving a placebo or reference drug.
25
What is the purpose of a control group in an RCT?
Show answer
The control group is used to provide a baseline for comparison, allowing researchers to determine if the experimental drug has a significant effect by comparing the outcomes of the test group to the control group.
26
What is the goal of Phase 1 clinical trials?
Show answer
To determine the drug's most frequent side effects and how it is metabolized and excreted.
27
How many healthy volunteers are typically used in Phase 1 clinical trials?
Show answer
20-80
28
What is the goal of Phase 2 clinical trials?
Show answer
To obtain preliminary data on whether the drug works in people with a certain disease or condition.
29
What is the purpose of Phase III trials in drug development?
Show answer
To confirm efficacy by comparing the new medication to the standard treatment for the same disease.
30
What happens at the end of Phase III trials?
Show answer
Data are submitted to the FDA as a New Drug Application (NDA).
31
What is the purpose of Phase IV trials?
Show answer
To identify uncommon or delayed toxic effects
32
What is the FDA's MedWatch system?
Show answer
A voluntary system for reporting adverse events
33
What does the term 'Future' in the context of the slide refer to?
Show answer
The advancements and potential of drug discovery and medical innovations in the coming years.
34
What year is highlighted as significant for the intersection of AI and drug discovery in the slide?
Show answer
2025
35
What is the United States Pharmacopeia (USP)?
Show answer
An independent, scientific, and nonprofit organization founded in 1820.
36
What standards does the USP set for medications and dietary supplements?
Show answer
Purity, strength, and manufacturing quality.
37
What is the significance of the USP standards for medications in the USA?
Show answer
Medications in the USA follow the USP standards.
38
What is the Food and Drug Administration (FDA) responsible for?
Show answer
Protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologics, vaccines, medical devices, food supply, cosmetics, tobacco products, and devices that emit radiation.
39
What does the FDA monitor after drugs are released into the market?
Show answer
The FDA monitors the drug safety after drugs are released into the market.
40
What are the FDA regulations for drugs?
Show answer
Drugs include over-the-counter drugs and prescription drugs (brand-name and generic).
41
List the FDA regulations for cosmetics.
Show answer
Cosmetics include tattoos, perfumes, moisturizers, and lipstick & fingernail polishes.
42
What is the Drug Enforcement Administration (DEA) responsible for?
Show answer
The DEA enforces controlled substance laws and regulations, investigates and prosecutes violators of drug laws, and aims to reduce the supply and demand for controlled substances.
43
What must healthcare providers do to prescribe controlled substances?
Show answer
Healthcare providers must be registered with the DEA and include the DEA number in each controlled substance prescription.
44
What year was the Controlled Substances Act established?
Show answer
1970
45
How many classes does the Controlled Substances Act categorize drugs into?
Show answer
Five
46
What is the purpose of the DEA number for a licensed prescriber?
Show answer
To prescribe controlled substances
47
What are Schedule I drugs?
Show answer
Highest potential for abuse and no medical use. Examples include heroin, LSD, and marijuana.
48
What are Schedule II drugs?
Show answer
High potential for abuse leading to extreme psychological or physical dependence. Examples include morphine, codeine, and fentanyl.
49
What is the potential for physical and psychological dependence associated with Schedule III drugs?
Show answer
Moderate to low
50
What are some examples of Schedule III drugs?
Show answer
Drugs containing less than 90 milligrams of codeine, barbiturates, and ketamine
51
What is the potential for abuse and risk of dependence associated with Schedule IV drugs?
Show answer
Low potential for abuse and low risk of dependence
52
What are conventional drugs?
Show answer
Pharmaceutical medications with defined chemical structure that are chemically synthesized.
53
What are prescription medications?
Show answer
Medications dispensed from a licensed pharmacy, used to treat certain medical conditions under supervision of a healthcare provider, and are more potent.
54
What is the difference between prescription and over-the-counter medications?
Show answer
Prescription medications require a healthcare provider's supervision, while over-the-counter medications are available for self-treatment and have a higher margin of safety.
55
What are biologics/biosimilars?
Show answer
Medications made in living cells like hormones, therapeutic antibodies, vaccines, growth factors, via the parenteral route.
56
What are antisense oligonucleotides and siRNA?
Show answer
Short chain nucleic acids that can alter gene expression, via the parenteral route.
57
What is gene therapy?
Show answer
Repairing a faulty gene via viral vectors and others.
58
What is the definition of a chemical name in drug nomenclature?
Show answer
A chemical name describes the chemical structure of a drug.
59
What is the purpose of a generic name in drug nomenclature?
Show answer
A generic name is a shortened version of the chemical name used by health professionals.
60
What is the purpose of a brand/trade name in drug nomenclature?
Show answer
A brand/trade name is given by pharmaceutical companies that make the medication.
61
What is the difference between a brand name and a generic name?
Show answer
A brand name is given by the pharmaceutical company and suggests the drug action, while a generic name is the official, non-proprietary name that identifies the active ingredient.
62
What is the significance of the uppercase letter in brand names?
Show answer
Brand names always start with an uppercase letter.
63
What is the purpose of an Abbreviated New Drug Application (ANDA)?
Show answer
To approve a generic drug that is bioequivalent to the brand-name version.
64
What must manufacturers submit to demonstrate bioequivalence for a generic drug?
Show answer
Data showing the same active ingredient(s) with the same strength, dosage form, route of administration, indications, and absorption.
65
What is the number of prescription drugs in the US market?
Show answer
> 20,000
66
What is the key principle emphasized in the slide regarding drug behavior prediction?
Show answer
Understanding the principles of pharmacology
67
What is the intended action of a drug?
Show answer
A therapeutic effect, such as a bronchodilator improving airflow in the airways.
68
What are side effects?
Show answer
Mild effects that can vary in intensity among individuals.
69
What is an adverse drug reaction?
Show answer
A more severe reaction, such as pseudomembranous colitis with certain antibiotics.
70
What are the key factors a prescriber should consider before prescribing a drug?
Show answer
Purpose or indication of a drug, Mechanism of action, Side effects, Contraindications, Abnormal adverse effects, Administration route of choice, Home instructions, Proper documentation
71
What does the term 'contraindications' refer to in the context of drug prescribing?
Show answer
Conditions or circumstances under which a drug should not be prescribed
72
What is pharmacokinetics?
Show answer
How drugs get into our body, including absorption and elimination.
73
What does pharmacodynamics study?
Show answer
What medications do to our body, focusing on individual differences in drug response.
74
What is pharmacogenomics?
Show answer
The study of how genetic variations influence drug response and optimal drug dose.
75
What is the consequence of not applying general pharmacology rules?
Show answer
Drug prescription errors
76
Why do we learn pharmacology principles?
Show answer
To prevent drug prescription errors
77
What is pharmacokinetics?
Show answer
The study of how the body processes medications, including absorption, distribution, metabolism, and excretion.
78
What does pharmacokinetics describe?
Show answer
The movement and modification of medication in the body.
79
What is the first pharmacokinetic phase?
Show answer
Drug Absorption
80
What is the second pharmacokinetic phase?
Show answer
Drug Distribution
81
What is the third pharmacokinetic phase?
Show answer
Drug Metabolism
82
What is the fourth pharmacokinetic phase?
Show answer
Drug Excretion
83
What are the three major routes of elimination for drugs?
Show answer
Hepatic metabolism, biliary elimination, and urinary excretion
84
What are absorption and distribution in the context of drug movement?
Show answer
The movement of the drug from the site of administration to the systemic circulation and to the tissues/organisms
85
What is drug absorption?
Show answer
The movement of a drug from the site of administration into systemic circulation (blood).
86
What are the drug-associated factors that influence absorption?
Show answer
Chemical structure, solubility, dosage form, and formulation of the drug.
87
What are the patient-associated factors that influence absorption?
Show answer
Route of administration, blood flow to the absorption site, pH at the injection site, disease state, and the biological membranes to overcome.
88
What is bioavailability?
Show answer
The fraction of a drug that is absorbed into the systemic circulation and available to exert its pharmacological effect.
89
List the factors affecting absorption.
Show answer
Dosage form and route of administration, first-pass metabolism, transport across membrane, blood supply to the biological compartment, physical and chemical properties, disease state.
90
What is bioavailability?
Show answer
Bioavailability is the fraction of drug absorbed into the systemic circulation.
91
How is bioavailability calculated?
Show answer
Bioavailability is calculated as AUC oral divided by AUC IV, multiplied by 100.
92
What are the factors affecting bioavailability?
Show answer
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.
93
What is bioavailability?
Show answer
The extent to which a drug is absorbed into the bloodstream and becomes available at the site of action.
94
Why do very lipophilic drugs have poor bioavailability?
Show answer
Because they are insoluble in aqueous body fluids.
95
What is the difference between intravenous (IV) and intramuscular (IM) injections?
Show answer
IV injections deliver medication directly into the bloodstream, while IM injections inject medication into the muscle tissue.
96
List the three types of parenteral dosage forms mentioned in the slide.
Show answer
Parenteral dosage forms include intravenous (IV), intramuscular (IM), and subcutaneous (SC) injections.
97
What are the two main categories of drug administration routes?
Show answer
Local and Systemic
98
What does the term 'Local' refer to in the context of drug administration?
Show answer
Routes that deliver drugs directly to a specific site without entering the bloodstream.
99
What are the subcategories of the 'Local' route?
Show answer
Topical, ocular, intrathecal route
100
What are the factors governing the route of choice in drug administration?
Show answer
Drug stability, pharmacokinetic profile, clinical settings, and patient's condition.
101
What does the pharmacokinetic profile include?
Show answer
Impact of metabolism (GI and Liver), required site of action, and required onset of action.
102
What are the advantages of parenteral administration?
Show answer
Direct delivery to the bloodstream, rapid onset of action, and bypasses the first-pass effect.
103
What are the disadvantages of parenteral administration?
Show answer
Painful injections, risk of infection, and potential for extravasation.
104
What are the advantages of oral administration?
Show answer
Convenient, non-invasive, and can be self-administered.
105
What are the disadvantages of oral administration?
Show answer
Potential for first-pass metabolism, slower onset of action, and variable absorption.
106
What are the advantages of sublingual/buccal administration?
Show answer
Rapid absorption, avoids first-pass metabolism, and can be self-administered.
107
What are the disadvantages of sublingual/buccal administration?
Show answer
Potential for rapid degradation, limited drug stability, and variable absorption.
108
What are parenteral drugs?
Show answer
Parenteral drugs are medications that are administered directly into the body, bypassing the digestive system.
109
What are the four types of parenteral drug administration shown in the slide?
Show answer
Intravenous injection, subcutaneous injection, intramuscular injection, and dermal injection.
110
Why must parenteral drugs be manufactured under strict sterile conditions?
Show answer
To prevent contamination and ensure the safety and efficacy of the medication.
111
What is the bioavailability of intravenous drugs?
Show answer
Almost 100%
112
What are the advantages of intravenous drug administration?
Show answer
Immediate effect, no absorption required, suitable for drugs that can/can't be absorbed orally.
113
What is the absorption rate of intramuscular injections?
Show answer
Relatively rapid due to high vascularity (5-20 min)
114
What are the disadvantages of intramuscular injections?
Show answer
Injection site pain, possibility of hematoma, abscess, nerve injury
115
What are the advantages of subcutaneous injections?
Show answer
Slower onset and smaller injection volumes, suitable for aqueous and depot, patient can self-administer
116
What is the definition of sublingual administration?
Show answer
Placement of drug under the tongue.
117
What is the advantage of sublingual administration?
Show answer
Convenience and ease of administration, rapid absorption, bypass of GI enzymes and liver metabolism.
118
What is the difference between sublingual and buccal administration?
Show answer
Sublingual is under the tongue, buccal is between the cheek and gum.
119
What is the most common route of drug administration?
Show answer
Oral administration
120
Where do oral drugs undergo dissolution and absorption?
Show answer
Stomach or intestine
121
What is the purpose of enteric coated capsules?
Show answer
To delay the release and absorption of drugs until they reach the alkaline environment of the intestine
122
What is the primary site of drug absorption in the body?
Show answer
The intestine
123
What is passive diffusion?
Show answer
The movement of substances from a high concentration to a low concentration without the need for energy
124
Which type of drug is absorbed more easily by passive diffusion?
Show answer
Lipid-soluble drugs
125
What is facilitated diffusion?
Show answer
Facilitated diffusion is the movement of molecules across a cell membrane with the help of carrier proteins, requiring no energy.
126
How does active transport differ from facilitated diffusion?
Show answer
Active transport requires energy (ATP) and can get saturated or inhibited, whereas facilitated diffusion does not require energy.
127
What is endocytosis and how does it differ from active transport?
Show answer
Endocytosis is the engulfment of large molecules by endocytic vesicles, differing from active transport which requires energy and carrier proteins.
128
What are Gastroretentive Drug Delivery Systems?
Show answer
Drug delivery systems designed to remain in the stomach for extended periods.
129
List the types of Gastroretentive Drug Delivery Systems mentioned in the slide.