Pharma Blog
Oral Medication with Food versus When Fasted
Do we know there is a difference when we take medication orally with food versus when fasted? In a field known as pharmacokinetics, we measure the drug levels in blood with time. When we take medication orally, the blood drug concentration will increase to a maximum value (Cmax) at a ... Read More
Cleaning Validation | FDA vs EMA
I have reviewed 50+ cleaning validation protocols this year. And here is what still surprises me: Most companies treat FDA and EMA requirements as identical twins. They are not. The reality is: Last year, a client passed their FDA pre-approval inspection comfortably. Same facility. Same equipment. Same cleaning procedures. Three ... Read More
Differential Binding of Drug to Plasma Proteins and Tissue Proteins
Do we know that substances in blood are being transported around our body by vehicles known as ‘plasma proteins’? In a field known as pharmacokinetics, scientists study how the differential binding of drug to plasma proteins and tissue proteins defines how extensively the drug is being distributed to the bodily ... Read More
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