Formulation Development
Statistics Required in Formulation Development
1. Formulation development is not trial and error. 2. The purpose of statistics in pharmaceutical R and D is not ...
API Particle Size Distribution (PSD) Matters in Generic Formulations
In generic oral solid dosage forms, API particle size distribution is not just a physical parameter—it is a critical material ...
Lean Six Sigma and QbD
Quality by Design (QbD) is a science- and risk-based approach outlined in ICH Q8, Q9, and Q10. It emphasizes that ...
Relationship Between QTPP and CQA
Introduction In QbD) the development of a pharmaceutical product starts with understanding the patient and therapeutic needs. These needs are ...
Quality Target Product Profile (QTPP) in Pharmaceutical Development
The Quality Target Product Profile (QTPP) is a prospective summary of the key quality characteristics that a drug product should ...
Lean Six Sigma in Pharmaceutical Formulation Development – A Practical Perspective
In today’s competitive pharmaceutical environment, cost optimization, regulatory compliance, and speed to market are critical success factors. While Quality by ...