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Questions and Answers
What is the main objective of developing and evaluating an IVIVC?
What is the main objective of developing and evaluating an IVIVC?
- To assess batch-to-batch consistency of solid oral dosage forms
- To predict in vivo drug release profiles
- To optimize product formulation based on achieving specific dissolution targets
- To establish the dissolution test as a surrogate for human studies (correct)
When does dissolution testing play a vital role in the pharmaceutical industry?
When does dissolution testing play a vital role in the pharmaceutical industry?
- During routine manufacturing for product release decisions (correct)
- During generic product development for regulatory approval decisions
- During post-approval process or formulation changes for equivalence decisions
- During optimization of product formulation and manufacturing process
What are the typical situations where dissolution testing plays a vital role?
What are the typical situations where dissolution testing plays a vital role?
- Reference product comparison, product development, batch-to-batch consistency assessment
- Drug development, post-approval process changes, human studies
- Clinical trials, manufacturing process optimization, regulatory approval decisions
- Formulation and optimization decisions, equivalence decisions, product compliance and release decisions (correct)
What does dissolution testing provide critical in vitro drug release information for?
What does dissolution testing provide critical in vitro drug release information for?
What is the purpose of dissolution testing in drug development and manufacturing?
What is the purpose of dissolution testing in drug development and manufacturing?
Which apparatus is standardized and specified in the United States Pharmacopeia (USP) General Chapter Dissolution?
Which apparatus is standardized and specified in the United States Pharmacopeia (USP) General Chapter Dissolution?
What is the temperature maintained for the dissolution medium within the vessels?
What is the temperature maintained for the dissolution medium within the vessels?
What is the main target of hydrodynamic studies in dissolution apparatuses?
What is the main target of hydrodynamic studies in dissolution apparatuses?
Why is degassing the dissolution medium important?
Why is degassing the dissolution medium important?
How are sample solutions collected from dissolution testing commonly analyzed?
How are sample solutions collected from dissolution testing commonly analyzed?
What is initiated if there is a deviation from the acceptable Q values at S3 testing?
What is initiated if there is a deviation from the acceptable Q values at S3 testing?
What do researchers suspect about USP Dissolution Apparatus 2 based on hydrodynamic studies?
What do researchers suspect about USP Dissolution Apparatus 2 based on hydrodynamic studies?
Which type of solutions can be used as a dissolution medium?
Which type of solutions can be used as a dissolution medium?
How are vessels of the dissolution method usually heated?
How are vessels of the dissolution method usually heated?
What is the main purpose of drug dissolution testing according to Qureshi and Shabnam (2001)?
What is the main purpose of drug dissolution testing according to Qureshi and Shabnam (2001)?
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