Answered: 5. What is meant by the shelf life and…

5. What is meant by the shelf life and expiration date of a drug product? Dis- cuss the various aspects of stability of a drug product. What

Curren'S Math For Meds: Dosages & Sol

11th Edition

ISBN:9781305143531

Author:CURREN

Publisher:CURREN

Chapter6: Oral Medication Labels And Dosage Calculation

Section: Chapter Questions

Problem 20SST

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Answer the following questions:1. If excipients do not have pharmacodynamic activity, how do excipients affect the performance of the drug product?2. What is meant by the rate-limiting step in drug bioavailability from a solid oral drug product?3. What is the usual rate-limiting step for a poorly soluble and highly permeable drug (BCS 2)?4. How could the manufacturing process affect drug product performance?5. Drug absorption involves at least three distinct steps: dissolution, permeation, and disposition during transit in GI (an additional step of drug disposition in the body is involved as well for bioavailability). How are these processes validated in vitro when the in vivo requirement for drug bioavailability is waived?6. What is meant by “sink” conditions?7. What physical or chemical properties of a drug substance are important in designing a drug for (a) oral administration or (b) parenteral administration?8. For a lipid-soluble drug that has very poor aqueous solubility, what…