Pharma Blog
Why Vape Laced with Etomidate is Dangerous?
In brain, etomidate binds to and activate gamma-alpha butyric acid (GABA) receptor. This causes amnesia (forgetfulness), ataxia (unstable movement) and confusion. It further affects ‘wiring’ of a small part of the brain (hippocampus) and may retard brain development of young vapers. It also suppresses hormone and affects kidney and lung ... Read More
Alfentanil Interaction with Rifampin
Alfentanil is a potent, short-acting analgesic drug used for anesthesia in surgery. When alfentanil is administered to patients who were pre-treated with rifampin, an anti-tuberculosis drug, its level in our body (i.e. systemic exposure), was reduced 2- to 3-fold! A question arises: What are the rationales behind this interaction? Another ... Read More
Factors Affecting on Clearance of Apixaban
As we develop drugs to be more stable in our body (i.e. less prone to be broken down by liver), guess what is another route that the drugs are being eliminated from our body? It is intestinal excretion of drugs from the blood circulation to the intestinal lumen and out ... Read More
Removal of Drugs from Kidneys
There are three processes that contribute to the removal of drugs in our kidneys. A question arises: How can we easily predict the relative contributions of these 3 processes? Simple solution: Compare renal clearance (CLR) and filtration clearance (CLf)! We may further ask: how do we calculate CLR and CLf? ... Read More
Why is Testing into Compliance Prohibited?
“Testing into Compliance” — A Red Flag for FDA Inspectors In pharmaceutical manufacturing, data integrity is non-negotiable. Yet some companies still engage in the risky practice of testing into compliance — retesting until a passing result is found, while ignoring or discarding out-of-specification (OOS) results without proper scientific justification. This ... Read More
FDA Guidance: Computer Software Assurance
FDA just released: Computer Software Assurance for Production and Quality System Software FOREWORD What’s new in CSA? The guidance introduces a paradigm shift: Key applications: CSA vs CSV – What’s the advantage? This means more time for innovation, less time buried in paperwork, and better assurance where it counts. CSA ... Read More
Best Practices for Managing Suppliers of API Manufacturers | APIC Guidance
The Best Practices Guide for Managing Suppliers of API Manufacturers (Version 2 – March 2024) is not a new regulatory framework, but a refined and practical reference document designed to support API manufacturers in strengthening supplier oversight and ensuring consistent quality across the supply chain. Together with the Annex 2 ... Read More
Understanding the Inactive Ingredient Guide (IIG)
The Inactive Ingredient Guide (IIG) is a regulatory database published and maintained by the United States Food and Drug Administration (USFDA). It serves as a critical reference for pharmaceutical scientists, formulation developers, and regulatory affairs professionals engaged in the development and approval of drug products—particularly generic drugs submitted through the ... Read More
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