Bioequivalence and Pharmaceutical Development

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What is the primary consideration when designing MR drug products for different routes of administration?

Physiochemical properties of the materials used in the dosage form

Pharmacokinetic properties of the drug

Pharmacodynamic properties of the drug and the materials used in the dosage form

All of the above (correct)

How many types of MR oral drug products are described based on drug release characteristics?

20 (correct)

30

25

15

What is the primary difference between delayed release and controlled release drug products?

Controlled release products have a faster onset of action

Delayed release products release a discrete portion of drug at a later time (correct)

Delayed release products have a shorter duration of action

Controlled release products have a higher bioavailability

What is the primary characteristic of controlled release drug products?

Active drug available over an extended period of time after administration Signup and view all the answers

What is the benefit of extended release drug products?

At least 2-fold reduction in dosage frequency Signup and view all the answers

What is the primary purpose of a prodrug?

To improve the solubility, increase chemical stability, or increase bioavailability of the active drug by decreasing first pass metabolism Signup and view all the answers

Which of the following is NOT a method for assessing bioavailability and bioequivalence?

In vivo cell culture study Signup and view all the answers

What is the primary difference between NDA and ANDA?

NDA is for new drug applications, while ANDA is for abbreviated new drug applications Signup and view all the answers

Which of the following is an example of a specific drug product that requires bioequivalence testing?

Chewable tablets Signup and view all the answers

What is the purpose of in vitro dissolution testing in bioequivalence studies?

To compare the rate of dissolution of the test and reference products Signup and view all the answers

Which of the following is a factor that can influence bioavailability?

All of the above Signup and view all the answers

What is the primary advantage of targeted-release drug products?

Release of drug at or near the intended physiologic site of action Signup and view all the answers

What is a potential disadvantage of extended release products?

Dose dumping - release of more than the intended fraction Signup and view all the answers

What is the primary characteristic of orally disintegrating tablets?

They disintegrate rapidly in the saliva after oral administration Signup and view all the answers

What is a benefit of extended release products in terms of patient care?

Reduction in adverse side effects and improvement in tolerability Signup and view all the answers

What is a characteristic of enteric coated types of MR oral drug products?

They are dependent on the environment Signup and view all the answers

When can an in vivo BE study of one or more lower strengths be waived?

If the drug product is in the same dosage form but has different strengths and is proportionally similar in active and inactive ingredients. Signup and view all the answers

What is the purpose of a Negative Formulary?

To list drug products that are not therapeutically equivalent, and/or the interchange of which is prohibited. Signup and view all the answers

What is another name for a controlled release drug product?

All of the above Signup and view all the answers

What is required for a generic product to be assumed therapeutically equivalent?

It must be approved as safe and effective, pharmaceutically equivalent, bioequivalent, adequately labeled, and manufactured in compliance with Current Good Manufacturing Practice regulations. Signup and view all the answers

What is the purpose of an in vivo BE study?

To determine the bioavailability of a drug product. Signup and view all the answers

What is a Modified Release Oral Drug Product?

A product that is formulated to alter the timing and/or rate of release of the drug. Signup and view all the answers