Chief Pharmacist
The Critical Role of PK and PD Studies in Regulatory Affairs Submissions
Pharmacokinetics (PK) and pharmacodynamics (PD) studies are essential pillars of drug development, directly influencing regulatory submissions and approvals. These studies ...
50 Common Biomarkers in Clinical Trials
1. Blood Pressure2. Heart Rate3. Cholesterol Levels4. Blood Glucose5. Tumor Markers6. Cytokines7. Gene Expression Profiles8. Hormone Levels9. Hemoglobin A1c (HbA1c)10. ...
ALCOA+ Principles in Pharmaceutical Indusrty
Attributable – Each entry traceable to the responsible individual Legible – Clear, permanent, and audit-ready records Contemporaneous – Entries made ...
505(b)(2) vs. ANDA | Choosing the Right FDA Pathway for Drug Approval
Navigating the U.S. regulatory landscape requires a clear understanding of approval pathways, especially when deciding between 505(b)(2) New Drug Applications ...
NME vs. NCE | Understanding the Difference in Drug Development
In regulatory affairs, we often hear the terms New Molecular Entity (NME) and New Chemical Entity (NCE) used interchangeably. However, ...
Why Distilled Water is Commonly Used in QC Testing?
Distilled Water is water that has been purified through the process of distillation.This process removes impurities, minerals, salts, and microorganisms, ...
Types of Water in Pharmaceutical Industry
Water is the most widely used raw material in pharmaceutical manufacturing, but did you know that different grades of water ...
The f2 Similarity Factor in Dissolution
One question that I frequently get about dissolution is what is the f2 factor and how should it be used? ...
Types of Standard Solution
It is a solution containing an accurately known concentration.A standard solution ideally has a high degree of purity and is ...
Molality (m)
Molality (m) is a measure of the concentration of a solute in a solution. It is defined as the number ...