100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
BTECH Test 2 Questions & Answers 2024/2025 £8.99
Add to cart
Quickly navigate to
Preview
  2.  
  3. BTECH
  4.  
  5. BTECH

Exam (elaborations)

BTECH Test 2 Questions & Answers 2024/2025
 0 purchase
  • Module
  • BTECH
  • Institution
  • BTECH

BTECH Test 2 Questions & Answers 2024/2025 FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from industry to fund/speed up reviews of different types of drugs. In the Generic & Biosimilars UFA, the final user fees are what percent of the typical user fees for a...

[Show more]

Preview 4 out of 36  pages

Document information

  • August 22, 2024
  • 36
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • btech test 2 questions answers

Written for

  • BTECH
  • BTECH

Seller

avatar-seller
Bensuda

Reviews received

Content preview

BTECH Test 2 Questions & Answers
2024/2025

FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from industry to
fund/speed up reviews of different types of drugs. In the Generic & Biosimilars UFA, the final user fees
are what percent of the typical user fees for a branded drug PDUFA?



90%



10%



50%



30%



20% - ANSWERS10%



_________of a drug product is expressed as concentration (wt per vol, wt per wt, wt per tablet) or in
activity units (IU or international units). "




Strength



Formulation



Component



Therapeutic activity

,Inactive ingredient - ANSWERSStrength



What is true of biosimilars?



Same active ingredient



Same label design



Same route of administration



Same dosage form



Same strength - ANSWERSSame label design



What is not true of inactive ingredients?



Inactive ingredient is not the main drug component that is responsible for pharmacologic activity of a
drug product



Inactive ingredients include starch binders in tablets



Inactive ingredients are a common component of drug products



Inactive ingredients do not affect the safety properties of a drug product



Inactive ingredients include artificial colorants or preservatives - ANSWERSInactive ingredients do not
affect the safety properties of a drug product

,What is not true of biologics?

Susceptible to microbial contamination thus requiring aseptic or sterile handling techniques



Chemical characterization of a biologic is easily accomplished using analytical chemistry techniques



Biologics are generally heat sensitive



Biologics include insulin which is made up of 51 amino acids



"Biologics include antibodies, vaccines, stem cells, and blood products" - ANSWERSChemical
characterization of a biologic is easily accomplished using analytical chemistry techniques



Drug product refers to a finished dosage form. What is not considered a dosage form?



Tablets



Active ingredient



Syrups



Sublingual strips



Injectables - ANSWERSActive ingredient



"Which group in a drug development company performs comparability studies, or tests of product
attributes from one manufacturing batch to another?"




Research group

, Business development



Process development group



Legal



Quality control group - ANSWERSQuality control group



"In drug regulation, the use of a drug for a particular disease or condition is referred to as its:"




Indication



Abuse



Component



Active pharmaceutical ingredient



Providence - ANSWERSIndication



"Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000
patients in the US. What is not an incentive given to manufacturers to encourage the development of
orphan drugs?"



Tax incentives are given to the manufacturer



PDUFA fees are waived

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

Quick and easy check-out

You can quickly pay through credit card for the summaries. There is no membership needed.

Focus on what matters

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 Bensuda. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for £8.99. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

67479 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy revision notes and other study material for 15 years now

Start selling
£8.99
  • (0)
Add to cart
Added