Associate Scientific Manager Interview Questions and Answers

RLD is a reference listed drug while in-house formulation is developed by the company itself.

• RLD is an already approved drug that serves as a reference for generic drug development

• In-house formulation is developed by the company itself and may or may not have an RLD

• RLD is used to establish bioequivalence of generic drugs

• In-house formulation may have unique characteristics or advantages over RLD

Stability studies for biologicals are essential to ensure their safety and efficacy.

• Stability studies involve testing the biological product under various conditions to determine its shelf life and storage requirements.

• Factors such as temperature, humidity, light exposure, and pH can affect the stability of biologicals.

• Stability testing is conducted at different stages of product development, including preclinical and clinical phases.

• The results of stability studies are used ...read more

Biosimilars are similar but not identical to the original biologic drug, while generics are identical copies of the original small molecule drug.

• Biosimilars are made from living cells and are more complex than small molecule generics.

• Biosimilars undergo a rigorous approval process to ensure they are similar in safety and efficacy to the original biologic drug.

• Generics are cheaper than the original drug and have the same active ingredient, dosage form, and route of administrat...read more

ICH guidelines provide recommendations for the development and registration of biological products.

• ICH guidelines cover topics such as quality, safety, and efficacy of biological products

• Guidelines include specific requirements for clinical trials and post-marketing surveillance

• Examples of ICH guidelines for biologicals include Q5A(R1) on quality of biotechnological products and Q6B on specifications for biotechnological products