Pharma Blog
What Is the FDA Orange Book, and Why Should Every Formulation Scientist Understand It?
For anyone working in pharmaceutical R&D, regulatory affairs, or generic drug development, the FDA Orange Book is not just a regulatory reference—it’s a strategic tool that can significantly influence the success of your product development. Officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is published by ... Read More
Selection of Reference Product Across Different Regulatory Markets
Selecting the appropriate reference product is a key step in generic drug development. It serves as the basis for bioequivalence studies and regulatory submissions. The definition and selection criteria for a reference product vary by region, as outlined below. 1. United States (USFDA) – Reference Listed Drug (RLD) The USFDA ... Read More
Is f₂ in Multimedia a True Indicator of Bioequivalence?
The f₂ similarity factor is a commonly used mathematical tool in pharmaceutical development to compare the dissolution profiles of a test product and its reference listed drug (RLD). When the calculated f₂ value is ≥ 50, it indicates that the two profiles are similar under the tested conditions. Regulatory agencies ... Read More
R&D Guide to Dissolution Specification Setting
Setting dissolution specifications at the R&D stage is a critical step in pharmaceutical product development. It ensures that the formulation will consistently meet performance expectations and regulatory requirements. Here’s a clear step-by-step guide: How to Set Dissolution Specifications in R&D 1. Understand the Role of Dissolution Dissolution testing predicts how ... Read More
Anatomy of an FDA Inspection | Part 2 of 2
Winning the Inspection Game – The Habits of Inspection-Ready Companies LIVE THE CULTURE: The entire organization, from top management to line operators, knows that quality isn’t a department—it’s a mindset. It’s part of the air you breathe, the decisions you make. Follow SOPs consistently, encourage employees to report and fix ... Read More
Anatomy of an FDA Inspection | Part 1 of 2
Inspections are how the FDA checks that what’s promised is real: FDA inspections can occur for various reasons – a routine schedule, a follow-up to a prior issue, a pre-approval for a new product, or “for-cause” in response to a specific problem. What Happens During an FDA Inspection? (And What ... Read More
How Are Nitrosamine Impurities Generated in Pharmaceuticals?
Nitrosamines are formed through specific chemical reactions during drug manufacturing or storage. These impurities have become a major focus for regulatory bodies due to their potential health risks. Here’s how they are generated: 1. Reaction Between Nitrites and Amines: 2. Use of Nitrosating Agents in Manufacturing: 3. API Degradation: 4. ... Read More
Determination of Dissolved CO2 in Soft Drinks
A Hands-On Experiment with Dissolved CO2 I’ve always wondered about the science behind the things we do every day. I recently set out to measure the ‘fizz’ in soft drinks by finding out how much CO2 is dissolved. This was a wonderful experiment of titration with sodium hydroxide. It wasn’t ... Read More
The Science Behind the Drug Potency
The science behind drug potency is far more complex than you think. If you’re in pharmaceuticals or biotechnology, you’ll frequently hear the term “potency.” But what exactly does it mean, and why is it important? What is Drug Potency? Potency refers to the amount (dose or concentration) of a drug ... Read More
Can You Crush a Tablet Before Taking It?
Whether it’s for your grandma who can’t swallow, or your child who hates medicine… many of us have crushed tablets thinking it’s harmless. But did you know? Not every tablet is made for that. Let’s break it down simply: Tablets You Should NEVER Crush: 1. Enteric-Coated Tablets (EC) 2. Extended-Release ... Read More
Can You Store Tablets in the Fridge?
Short Answer: No, unless the label or pharmacist says so. Why You Shouldn’t Refrigerate Tablets? 1. Condensation = Killer 2. Not Designed for Cold 3. Packaging Breakdown When Fridge Is Okay for Medicines? Only store in the fridge if the label or pharmacist clearly says: “Store at 2–8°C” Examples: Insulin, ... Read More