Articles by Sean
Types of Stability Tests for Quality Control
Stability testing of drug products is a regulatory requirement for pharmaceutical companies who want to market and sell their drugs. This article highlights the importance of stability testing and how stability programs are conducted. We will also look at several stability tests that are used to assess chemical degradation and determine the medicine’s overall shelf life. […]
Reviewing Literature Reviews for Quality
Literature reviews offer a convenient way to understand a field of research quickly. Packed full of peer-reviewed information, they provide an entry point to broad topics, saving us time and effort sifting through countless isolated papers. However, we need a systematic method for reviewing literature reviews, ensuring we only use those that avoid bias and contain high-quality references. […]
Complete Guide to All 31 FDA New Drug Approvals in 2022
It’s that time of the year again as we walk you through the FDA new drug approvals over the past twelve months. We break down the approvals by the numbers and highlight each small molecule and biologic therapy approved. We provide a short description of how they work, their competitors and pivotal clinical trials for all 31 new medicines entering the market in 2022. […]
SCE and FD Calculations for Isotonic Solutions
When formulating liquid drugs, we sometimes need them to be isotonic (have the same salt concentration as our body fluids) to prevent patient discomfort. This guide shows you how to calculate and adjust the tonicity of solutions using two different methods: sodium chloride equivalence (SCE) and freezing point depression (FD). […]
Preventing Chemical Degradation of Drug Products
While developing a drug product, we often overlook the chemical stability of the ingredients. Many drug components are susceptible to reactions like hydrolysis and oxidation, reducing the drug’s overall effectiveness before reaching the patient. How do we determine the shelf life of a drug, and how can we reduce chemical degradation? […]
Sean is a consultant for clients in the pharmaceutical industry and is a lecturer at a local university, where unfortunate undergrads are subject to his ramblings on chemistry and pharmacology.
