Analytical method development in Pharmaceutical industry l 21 basic and important Interview Question
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Questions covered:
Q. What is the purpose of analytical method validation?
Q. What are the key parameters evaluated during analytical method validation?
Q. How is accuracy assessed during method validation?
Q. What is method precision, and how is it evaluated during method validation?
Q. How is specificity demonstrated during analytical method validation?
Q. What is linearity, and how is it assessed during method validation?
Q. How do you determine the range of an analytical method?
Q. What is the significance of evaluating method robustness during validation?
Q. What is the detection limit, and how is it determined?
Q. How do you validate analytical methods for stability-indicating assays?
Q. Explain the concept of intermediate precision and its importance in method validation?
Q. What is the difference between the limit of detection (LOD) and the limit of quantification (LOQ)?
Q. How do you handle validation for chromatographic methods, such as HPLC or GC?
Q. What is the role of system suitability testing in analytical method validation?
Q. How do you establish the appropriate sample preparation techniques during method validation?
Q. What are the acceptance criteria for precision during method validation?
Q. How do you address the issue of matrix effects during method validation for complex sample matrices?
Q. What are forced degradation studies, and why are they performed during method validation?
Q. How do you validate bioanalytical methods, such as assays for pharmacokinetic studies?
Q. When should method validation be performed in the lifecycle of an analytical method?
Q. What documentation is typically required for analytical method validation?
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