Part 3 Flashcards
What is a treatment IND?
A treatment IND permits the use of an investigational drug for the treatment of patients who aren’t enrolled in the clinical study but have severe life-threatening disease for which there is no available treatment.
For products to be considered for this, the drug MUST be under active investigation in a controlled clinical trial with sufficient evidence of its safety and efficacy for use in the intended patients
What is an orphan drug?
a rare disease that effects fewer than 200,000 people in the United States
Can a sponsor withdraw an IND at any time?
YES
Explain a normal distribution sample for dosage of a drug
a normal distribution sample for drug dosage is a bell curve. An “average” effect will be produced in most people. However, a portion of the population will experience an effect greater than average or little effect.
For sensitive individuals, will they fall on the right or left side of the bell curve
What about resistant individuals?
sensitive patients will experience a greater than average effect on the average dosage of a drug. Therefore, they will fall more to the right side of a bell curve
Resistant individuals will experience little effect and will fall on the left side of the bell curve
What do MEC and MTC stand for and what graph are they found on
MEC — minimum effective concentration
MTC — Minimum toxic concentration
found on “drug profile in systemic circulation” graph
To provide systemic effects, a drug must….
-be absorbed from its route of administration at a suitable rate
-be distributed in adequate concentration to its receptor sites
-remain at the receptor sites for a specific period
What is a measure of a drug’s absorption characteristics?
its blood serum concentration at various intervals after the drug’s administration
Describe further what MEC means
minimum effective concentration
= the minimum concentration that can be expected to produce the drug’s desired effect in a patient
Any value of serum concentration above MEC has…
therapeutic effect
If a drug takes 2 hours after administration to reach MEC, and falls back to MEC 10 hours after administration, when should the 2nd dose be taken if it were desired to maintain the drug serum concentration above MEC for a longer period
2nd dose should be taken at hour 8 after administration
Explain further what MTC means
MTC— Minimum toxic concentration
If the blood serum concentration goes higher than MTC, dose-related toxic effects would occur in the average individual
We want the serum-drug concentration to be….
between MEC and MTC for the desired effect period
After a drug is taken, is it immediately available in the body?
no - it takes time
What can you say about a drug that has a low lethal dose
it is closely monitored. takes only a small amount of ingestion for the drug to be lethal to the patient
Why is acetaminophen not monitored?
because the lethal dose and even the toxic dose is very high
Drug substance concentration can be measured in ___ or ___
mcg/mL mg/mL etc
At the time of submitting an NDA, you must include a proposed…….
PACKAGE INSERT
name everything that must be included in the proposed package insert (11 things)
-description
-clinical pharmacology
-indications and usage
-contraindications
-warnings
-precautions
-adverse reactions
-drug use and dependence
-overdosage
-dosage and administration
-how supplied (available dosage forms, strengths, NDC’s)
What does NDC stand for
national drug code
The FDA must respond to an NDA within _____ days of receipt of an application
180
If an FDA sends an action letter of approval of an NDA, what happens next?
the product is marketed and phase 4 of clinical trials is conducted. Postmarketing surveillance
After a drug has hit the market (NDA has been approved) what must the sponsor do
-the drug’s sponsor is required to report each drug experience that is both serious and unexpected within 15 days.
-Other adverse events are reported quarterly for 3 years following approval and yearly thereafter
Also, the drug’s sponsor must submit annual reports each year
What do SNDA and ANDA stand for
SNDA — supplemental new drug application
ANDA – Abbreviated new drug application
Explain the circumstances in which a SNDA (SUPPLEMENTAL NDA) is submitted
A drug that has ALREADY had an approved NDA.
sponsor must submit an SNDA if…
-they change the method of synthesis of the drug
-different facility to manufacture
-change in formulation
-change in the container
-extension of the expiration date of a product based on new stability data
-any labeling change that doesn’t add to or strengthen a PREVIOUSLY APPROVED label statement
A company with a previously approved NDA is changing the container for their product.
does an SNDA need to be submitted?
YES — if they’re simply changing the SIZE of the container and not the type of container, then SNDA does not need to be submitted
A company is extending the expiration date on a product with an approved NDA. Does an SNDA need to be submitted?
it depends
If the expiration date is being lengthened due to NEW STABILITY DATA, then the SNDA does have to be submitted
if the expiration date is being lengthened based on full shelf-life data obtained from a protocol in the APPROVED application, then it is not required
a company is changing the label on a product that has an approved NDA. Does an SNDA need to be submitted?
it depends
SNDA DOES NOT NEED TO BE SUBMITTED IF..
they are minor editorial changes to add or strengthen an already approved label section
SNDA NEEDS TO BE SUBMITTED: if the labeling change does not add to or strengthen a previously approved label statement
When is an ANDA (abbreviated NDA) submitted
For duplicates (generics) of drug products previously approved
Single dose definition
the amount taken at 1 time
Total dose definition
the total amount taken during the course of therapy
Daily dose can be divided into…
divided doses — two or more times a day
What is the dosage regimen
the schedule of dosing (ie: 4 times a day for 10 days)
Where can the usual adult dose be found?
PDR
What is the median effective dose of a drug
the amount that produces the desired intensity of effect in 50% of individuals tested
What is the median toxic dose of a drug
the amount of a drug that produces toxic effects in 50% of individuals testd
What is the MEC
minimum effective concentration —
the minimum blood serum concentration of a drug that can be expected to produce the drug’s desired effect
What is MTC
minimum toxic concentration–
the base level of blood serum concentration that produces dose-related toxic effects
What does priming/loading dose mean
for certain drugs, a larger than usual initial dose may be required to achieve the desired blood drug level.
This larger than usual initial dose is called the loading/priming dose
What are maintenance doses
maintenance doses are those that are similar in amount to usual doses, and are administered after the loading dose to sustain the desired blood drug levels for optimal drug effects
What are prophylactic doses?
those that are designed to prevent a disease from occuring
ie: vaccines, aspirin
What are therapeutic doses?
those that are administered to counter a disease after exposure.
ie: anitoxins – antibodies to neutralize a toxin
USP DI is designed for..
patient and the pharmacist
Equivalent to PDR — designed for physicians
1 tablespoon = ___mL
1 teaspoon = ____ mL
1 tablespoon - 15 mL
1 teaspoon - 5mL
