Stability
![Stability Data and Evaluation of Finished Pharmaceutical Products](https://pharmadigests.com/wp-content/uploads/2024/03/Stability-study.png)
Stability Data and Evaluation of Finished Pharmaceutical Products
Stability Studies: A Brief Introduction Stability studies are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring their efficacy and safety throughout their lifespan. Long-term and accelerated studies are conducted to evaluate how products respond to various environmental conditions. Data from these studies help establish expiration ... Read More
![Stability Requirements for Oral Solid Formulations in ANDA](https://pharmadigests.com/wp-content/uploads/2023/08/IMG_20230812_084711.png)
Stability Requirements for Oral Solid Formulations in ANDA
When submitting an ANDA for a generic drug, one of the critical aspects is ensuring the product’s stability. The drug’s stability is a key factor in maintaining its safety, efficacy, and quality over its intended shelf life. Here are some key considerations: Long-term Stability: The generic drug product should retain ... Read More