24 Questions
What is the primary purpose of Phase III clinical trials?
To confirm earlier efficacy results and identify adverse events
What is the average time it takes for FDA approval after NDA filing?
18 to 24 months
What is the purpose of pre-formulation in product development?
To characterize the physical and chemical properties of the active ingredient
What is the significance of Phase III clinical trials in drug development?
70% chance of the product reaching the market
What is the purpose of formulation development in product development?
To develop initial drug formulations for early clinical studies
What happens to drugs after FDA approval?
They are subject to ongoing review for adverse side effects
What is considered during marketed product development?
The colour, size, shape, viscosity, skin feel, and production size
What happens during the marketed product development stage?
The drug is placed on the market and patients are monitored for side effects
What is the primary focus of Phase I clinical trials?
To test the absorption, metabolism, and excretion of the drug in the human body
What is the purpose of studying drug metabolism during the preclinical phase?
To understand how the drug is absorbed, distributed, and excreted by the body
What is included in the IND application submitted to the FDA?
The results of the preclinical work, the drug's chemical structure, side effects, and manufacturing information
In what phase of clinical trials is the drug tested on healthy volunteers?
Phase I
What is the primary goal of toxicity testing during the preclinical phase?
To determine the maximum dose of the drug that can be tolerated
What is the typical duration of clinical trials?
2-10 years
What is the purpose of the preclinical phase in drug development?
To determine the toxicity and efficacy of the drug in animal models
How many phases are involved in clinical trials?
3
What is the main difference between a Multiple Ascending Dose (MAD) study and a Single Ascending Dose (SAD) study?
The number of doses given to individual study subjects
What is the primary purpose of a Single Ascending Dose (SAD) study?
To obtain a rough understanding of a drug's single dose pharmacokinetics
What is reached in a Multiple Ascending Dose (MAD) study?
Steady state, when the rate of drug absorption is equal to the rate of drug elimination
What is the benefit of a Multiple Ascending Dose (MAD) study over a Single Ascending Dose (SAD) study?
It provides empirical confirmation of steady state concentrations
What is the significance of steady state concentrations in pharmacokinetics?
It is the point at which the rate of drug absorption is equal to the rate of drug elimination
Why is a placebo used in Phase 2 clinical trials?
To understand and determine if the drug is really helping the patient
What is the primary purpose of Phase 2 clinical trials?
To check the efficacy and impact of the drug on the body
What is the significance of Phase 2 clinical trials in drug development?
It determines the chances of the product reaching the market
Study Notes
Drug Discovery and Development
- The process of drug discovery and development involves several stages, including preclinical phase, clinical trials, and patenting.
Preclinical Phase
- Determine toxicity and efficacy in animal models.
- Continuously study drug metabolism and test for toxicity.
- Patent the drug.
Clinical Trials
- Design a manufacturing process to carry out clinical trials.
- Submit an Investigational New Drug (IND) application to the FDA.
- IND application includes preclinical work results, drug chemical structure, side effects, manufacturing information, and a detailed clinical trial plan.
Clinical Trials Phases
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Phase 1: Test drug on healthy volunteers (20-100) to determine toxicity relative to dose and screen for unexpected side effects.
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Phase 1 also determines how the drug is absorbed, metabolized, and excreted.
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Phase 1 usually lasts 3 years, and if passed, the chances of the product reaching the market are 70%.
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Phase 2: Test drug on 100-500 patients with the disease or condition to check efficacy and impact on the body, and to continue Phase 1 safety estimation.
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Some patients are given a placebo to understand and determine if the drug is really helping the patient.
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If passed, the chances of the product reaching the market are 60%.
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Phase 2 usually lasts 2 years.
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Phase 3: Test drug on a larger group of patients (1000-5000) and compare with existing treatments and a placebo.
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If passed, the New Drug Application (NDA) is submitted.
NDA Filing
- NDA contains all data supporting the efficacy and safety of the drug from preclinical and clinical studies.
- Approval can take 2 months to several years, but on average, it takes around 18 to 24 months.
Product Development
- Pre-formulation involves characterization of the physical and chemical properties of the active ingredient, therapeutic indication, and route of administration.
- Formulation development involves developing initial drug formulations for early clinical studies.
- Marketed product considerations include color, size, shape, viscosity, skin feel, and more.
Post-Market Monitoring
- Drug is placed on the market and patients are monitored for side effects.
This quiz explores the process of drug discovery and development, including preclinical phase, patenting, and testing for toxicity and efficacy.
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