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1.
Which method is commonly used to assess bioequivalence between a generic drug and its brand-name counterpart?
2.
Which of the following is a critical component of the ANDA (Abbreviated New Drug Application) submission?
3.
The dissolution testing of oral solid dosage forms is critical because it helps to predict:
Hint
4.
What is the primary goal of bioequivalence studies in the context of generic drug development?
5.
The guideline concerning the uniformity of dosage units requires that tablets and capsules contain a consistent amount of active ingredient. This ensures:
6.
Which ICH guideline specifically addresses the quality of biotechnological products?
7.
In which phase of drug development are generic drugs typically evaluated for bioequivalence?
8.
During the formulation of a generic drug, the polymorphic form of the active ingredient is considered to ensure:
Hint
9.
What is the main objective of ICH Q8 guidelines?
10.
Which process involves identifying, assessing, and controlling risks to quality throughout the product lifecycle?
11.
What is the significance of the Orange Book in generic drug development?
12.
What is the primary focus of the ICH Q9 guideline?
13.
According to the ICH stability guidelines, what are the recommended storage conditions for long-term stability testing of drug products intended for refrigerated storage?
14.
A common challenge in the development of generic topical formulations is ensuring:
15.
What is the main consideration when selecting the dosage form for a generic drug product?
