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:…
Q. What do you mean by pre-formulation study? A study conducted before the formulation development begins and aim to gather primary information about the physical and chemical properties of the drug substance, drug product and reference product (RLD). Q. What do you mean by RLD? RLD stands for Reference Listed Drug approved by regulatory authority…
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…
A list of interview questions and answers on intellectual property rights in pharmaceutical industry are given below: Q. What is Intellectual Property? Intellectual property (IP) refers to inventions. It is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create….
A list of common interview questions and answers on stability testing of pharmaceutical products are given below: Q. What is stability in pharmaceuticals? Stability in pharmaceuticals refers to the ability of a drug product to maintain its physical, chemical, and microbiological properties within a specified range over a given period of time under the influence…