15 Questions
What is the main objective of developing and evaluating an IVIVC?
To establish the dissolution test as a surrogate for human studies
When does dissolution testing play a vital role in the pharmaceutical industry?
During routine manufacturing for product release decisions
What are the typical situations where dissolution testing plays a vital role?
Formulation and optimization decisions, equivalence decisions, product compliance and release decisions
What does dissolution testing provide critical in vitro drug release information for?
Quality control purposes and drug development
What is the purpose of dissolution testing in drug development and manufacturing?
To establish safety and efficacy of a drug product without in vivo tests
Which apparatus is standardized and specified in the United States Pharmacopeia (USP) General Chapter Dissolution?
USP Dissolution Apparatus 1 – Basket
What is the temperature maintained for the dissolution medium within the vessels?
37 °C ± 0.5 °C
What is the main target of hydrodynamic studies in dissolution apparatuses?
USP Dissolution Apparatus 2
Why is degassing the dissolution medium important?
The presence of dissolved gases may affect results
How are sample solutions collected from dissolution testing commonly analyzed?
HPLC or Ultraviolet–visible spectroscopy
What is initiated if there is a deviation from the acceptable Q values at S3 testing?
An OOS (Out of Specification) investigation
What do researchers suspect about USP Dissolution Apparatus 2 based on hydrodynamic studies?
It provides inconsistent and sometimes faulty data
Which type of solutions can be used as a dissolution medium?
Degassed or sonicated deionized water to pH adjusted chemically-prepared solutions and mediums that are prepared with surfactants
How are vessels of the dissolution method usually heated?
Partially immersed in a water bath solution or heated by a jacket
What is the main purpose of drug dissolution testing according to Qureshi and Shabnam (2001)?
To establish safety and efficacy of a drug product without in vivo tests, following minor formulation and manufacturing changes
Test your knowledge about drug dissolution testing in the pharmaceutical industry with this quiz. Learn about its critical role in quality control and drug development, and how it aids in formulation and optimization decisions.
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