Frequently Asked Questions on ICH Q14 – Analytical Method Development

Frequently Asked Questions on ICH Q14 – Analytical Method Development

ByPharmaexam Reading Time: 2 minutes

Q. What is ICH Q14? A: ICH Q14 is a guideline from the International Council for Harmonization (ICH) that focuses on analytical procedure development. It complements ICH Q2(R2), which covers method validation. Q. What are the key elements of ICH Q14? A: The key elements include: Q. What is an Analytical Target Profile (ATP)? A:…

Common Interview Questions and Answers on Analytical Development

Common Interview Questions and Answers on Analytical Development

ByPharmaexam Reading Time: 5 minutes

Q. What is Dissolution? Dissolution rate may be defined as amount of drug substance that goes in the solution per unit time under standard conditions of liquid/solid interface, temperature and solvent composition. It can be considered as a specific type of certain heterogeneous reaction in which a mass transfer results as a net effect between…