Pharma Specialists

Stability Study

How do We Correlate Open Exposure Studies with Accelerated Stability Conditions?

This is a common and very practical question faced during pharma…

February 13, 2026

Stability Study

Stability Testing During Site Transfer of a Commercial Product

Question Received: If a routine commercial product with a proven…

November 18, 2025

Stability Study

Extrapolation and Regression Study in Stability Analysis

Stability analysis is a critical aspect of pharmaceutical produc…

November 03, 2024

Stability Study

Freeze-Thaw Study in Drug Products

A Freeze-Thaw study is a critical stability test for drug produc…

November 02, 2024

Stability Study

Lean Stability and Risk-Based Approaches for Pharmaceutical Stability Strategies

Lean Stability and Risk Based approaches can significantly enh…

September 03, 2024

Stability Study

Considerations Related to Stability after Opening of Nonsterile Dosage Form

When it comes to the stability and safe use of nonsterile dosage…

September 01, 2024

Stability Study

Post-approval and On-going Stability Commitment

Post-approval Stability Commitment A commitment which is submitt…

April 19, 2024

Dissolution

The Effect of Storage Conditions on Dissolution

Being a surrogate marker for bioequivalence, any change in disso…

April 19, 2023

Stability Study

Real Time Temperature Monitoring in Pharma

The digital revolution has revolutionized the pharma industry by…

March 18, 2023

Stability Study

Guidelines for Stability Testing of Pharmaceutical Products

Stability testing of pharmaceutical products provide an evidence…

December 07, 2022

Stability Study

Temperature Mapping in Stability Chamber

Temperature mapping is important for pharmaceutical stability st…

November 07, 2022

Stability Study

Forced Degradation Studies in Pharmaceutical Industry

In pharmaceutical industry, the forced degradation studies or …

July 25, 2022

Biotechnology

Stability Testing of Biotechnological and Biological Products | ICH Q5

The guidance stated in the ICH harmonised tripartite guideline S…

June 01, 2022

ICH

Stress Study of Pharmaceuticals

Stability study of a drug product is critically important to ens…

April 10, 2022

Calculation

Shelf Life Determination of Pharmaceutical Products

The shelf life of a drug preparation is the amount of time that …

November 09, 2021

Stability Study

Stability Study of Pharmaceutical Products (Basic Knowledge)

Climatic zones  The four zones in the world that are distinguish…

October 11, 2021

ANDA

Bracketing and Matrixing for Pharmaceutical Product Stability Study

Bracketing and matrixing are procedures for reducing the number …

October 08, 2021