Exam (elaborations)
Pharm 124 Bioavailability and Bioequivalence Exam
- Course
- Institution
Pharm 124 Bioavailability and Bioequivalence Exam...
[Show more]
Content preview
Pharm 124 Bioavailability and Bioequivalence ExamWhat is a multisource drug product? - ANSWER A drug product that contains the same
active drug substance in the same dosage form and is marketed by more than one
pharmaceutical manufacturer
Example:
10 mg Atorvastatin tablet by Pfizer
10 mg Atorvastatin tablet by Mylan
Single-source drug products - ANSWER Are usually brand name (innovator) drug
products
Drug product performance, in vivo - ANSWER The release of the drug substance from
the drug product leading to bioavailability of the drug substance
Biopharmaceutics - ANSWER The study of pharmaceutical formulation variables on the
performance of a drug product in vivo
What are the two types of in vivo drug product performance tests? - ANSWER 1.
Bioavailability studies
2. Bioequivalence studies
What is a type of an in vitro drug performance test? - ANSWER Dissolution profiles
What are bioavailability studies? - ANSWER Drug product performance studies used to
define the effect of changes in the:
1. Physiochemical properties of the drug substance
, 2. The formulation of the drug
3. The manufacture process of the drug product (dosage form)
When are Bioavailability studies performed? - ANSWER They are performed for both:
1. Approved active drug ingredients
2. Therapeutic moieties not yet approved for marketing by the FDA
What are bioequivalence studies? - ANSWER Drug product performance tests that
compare the bioavailability of the same active pharmaceutical ingredient from one drug
product (test) to a second drug product (reference)
What are dissolution and drug release tests? - ANSWER They are in vitro tests that
measure the rate and extent of dissolution or release of the drug substance from a drug
product, usually in an aqueous medium under specified conditions
What is SUPAC? - ANSWER -Stands for Scale-Up and Post-Approval Change
-Changes to the formulation after the drug product is approved by the FDA and
marketed
SUPAC could include a change in? - ANSWER -The supplier of the active ingredient
-The formulation
-Manufacturing process and/or site
What needs to be proven or demonstrated for SUPAC? - ANSWER You need to
demonstrate via in vivo bioequivalence studies or in vitro dissolution profiles that drug
product performance is the same before and after the SUPAC change
What is bioavailability? - ANSWER -The relative amount of an administered dose that
reaches the general circulation and the rate at which this occurs
-Describes the rate and extent to which the active drug ingredient or therapeutic
ingredient is absorbed from a drug product and becomes available at the site of drug
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Easton. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $9.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
82871 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now