In the meantime, I’ve read - still enthusiastically - another "essentials" booklet by Patric U.B. Vogel. In today's post, I’d like to introduce the book "Laboratory Statistics for Technical Assistants and Students" (2021 published by Springer Spektrum, Wiesbaden; ISBN: 978-3-658-33206-8) and provide my personal feedback.
The group of vascular endothelial growth factors (VEGF) plays a crucial role in the formation of new blood vessels (angiogenesis), since they stimulate the growth, i.e. the division and migration of endothelial cells, as the name already suggests. Since some tumor types can better supply themselves with nutrients via increased angiogenesis and thus grow faster, anti-VEGF antibodies represent significant cancer therapeutics. However, the various types of cancer are not the only indication; enhanced angiogenesis is also important in certain eye diseases.
Anti-VEGF antibodies or fragments include bevacizumab (Avastin®), ranibizumab (Lucentis®) or aflibercept (Eylea®) and an increasing number of biosimilars already on the market and in late-stage clinical trials, such as Mvasi®, Zirabev® or BevaciRel®.
Today it is once again about the clarification of terms. I recently came across a wide variety of sensitivities, which we will explain today in their respective contexts. Where do they come from and why do they cause confusion?
If you ever wondered why the limit of detection (LOD) is actually calculated using the formula
LOD = 3.3 x standard deviation / slopecalibration curve
and where the 3.3 actually comes from, this article may shed some light on the subject.
And we continue reviewing pharmaceutical "essentials" books. With unbroken enthusiasm, I jumped at the book "Trending in the pharmaceutical industry" by Patric U.B. Vogel this time, published in 2020 by Springer Spektrum, Wiesbaden (ISBN: 978-3-658-32206-9) and spent a cozy evening in front of the chimney.
In case analytical methods are evaluated for their suitability, the parameter "trueness" must also be considered during method validation for quantitative analyses of impurities as well as for content determinations and potency assays according to the method validation guideline ICH Q2(R1).
The various techniques of Raman spectroscopy find a wide range of applications in the different areas of the pharmaceutical industry, be it for the detection of counterfeits, as an in-process control (IPC) during the production of the active pharmaceutical ingredient, for content determinations, as an ID test for vaccines, for the simultaneous determination of several product quality attributes (PQAs) as part of a rapid release strategy, up to sterility tests, to name just a few examples [1-4].
After outing myself in the last blog article as a fan of the "essentials" series, I’ve enthusiastically read some more books, but unfortunately haven’t found any time for reviews yet. This should change right now. Therefore, in this blog article I’d like to present the book "Quality Control of Vaccines" by Patric U.B. Vogel, published in 2020 by Springer Spektrum, Wiesbaden (ISBN: 978-3-658-31864-2). Of course, this book has also accompanied me - in keeping with tradition - on a vacation 😉