Q1. What is Out of specification (OOS)? is defined as those results of in process or finished product testing that does not comply with the pre-determined acceptance established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. Q2. What is Out of trend (OOT)? result ...

Q1. What are the Pharmacokinetics parameters? Absorption: Absorption rate constant, Bioavailability. Distribution: Apparent volume of distribution, Unbound fraction. Elimination: Rate of elimination, Clearance, Renal clearance, Metabolic clearance, Biological half-life. Q2. What do you mean by Cmax and ...

There is a common questions from newly graduated pharmacist -‘How do I prepare for a regulatory affairs interview?’ In reply of this questions we try to arrange few questions and answer for regulatory affair job exam preparation – Q1. What is Regulatory Affairs? Regulatory Affairs ...