Think out of the box

Review of the book “Arzneimittel-Entwicklung und Zulassung” (drug development and market authorization)

Written by Dr. Janet Thode on . Posted in Think out of the box

And once again a technical book accompanied me on vacation and aided in avoiding my gray matter to rust completely ;-)

I’d like to use this blog article to describe my impressions of the book “Drug Development and Market Authorization” by Niels Eckstein (2nd edition from 2018, published by Deutscher Apotheker Verlag Stuttgart, ISBN: 978-3-7692-6992-5).

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Review of the book “Die Pharmaindustrie” (the pharmaceutical industry)

Written by Dr. Janet Thode on . Posted in Think out of the box

Since I was once more browsing for new books at Amazon, I was delighted (and shocked) to see that the next edition of the book "Die Pharmaindustrie" by Dagmar Fischer and Jörg Breitenbach (currently: 4th edition from 2013, published by Springer-Verlag Berlin Heidelberg, ISBN: 978-3-8274-2923-0) * will soon be published in October.

Delighted, because I am generally very enthusiastic about this book and shocked, because this means I should quickly write a review of the 4th edition to describe my impressions. I have to admit, this book has been with me a little longer and I've always read individual chapters (and commented for myself) from time to time, but not devoured the entire book in one go. Now is absolutely the time to take stock ;-)

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Review of the book „What's so funny about Microbiology?“

Written by Dr. Janet Thode on . Posted in Think out of the box

Sometimes you just need a smile in your dull everyday work...

The book "What's so funny about Microbiology?" by Joachim Czichos (7th extended edition from 2004, published by Czichos-Selbstverlag Ettlingen, ISBN: 3-00-003553-2, www.joachim-czichos.de) is perfect for this!

These wonderful, loving comics have accompanied me over 20 years ago during my time as trainee in a microbiological lab and everyone who is enthusiastic about microbiology will love this book!

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Review of the book „Arzneibuchanalytik“ (compendial analytics)

Written by Dr. Janet Thode on . Posted in Think out of the box

Just like my last book review about drug dosage forms, this book has also been part of a vacation 😉

In this blog article, I’d like to share my impressions of the book "Arzneibuchbuchanalytik" by Peter Imming (2nd edition, 2013, published in “wissenschaftliche Verlagsgesellschaft Stuttgart”, ISBN: 978-3-8047-2787-8).

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Review of the book „Arzneiformenlehre“ (lessons of drug dosage forms)

Written by Dr. Janet Thode on . Posted in Think out of the box

In today's blog article I’d like to think outside the box and describe my impressions of the book "Arzneiformenlehre" by Uwe Weidenauer (2nd edition, 2019, published in “wissenschaftliche Verlagsgesellschaft Stuttgart”, ISBN: 978-3-8047-3187-5).

This book has accompanied me on the last holiday and some relaxed days at the pool I dipped into it. Since I mainly worked in the fields of parenteralia so far, I thought it might make sense to get also a little bit familiar with the production of other dosage forms such as tablets, drops or ointments. This book offers a possibility, although the viewpoint has surprised me a bit. It is often written from the perspective of manufacturing in the pharmacy, which is quite interesting, but what I didn’t expect.

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Stability-indicating methods and their role in drug’s quality control

Written by Dr. Janet Thode on . Posted in Think out of the box

Have you ever thought about expiry dates on drug packages and wondered how these dates are determined? In today’s blog article we will discuss the very same topic from an analytical perspective.

Every drug product has a shelf life after which it starts to degrade. This shelf life is determined by the evaluation of storage conditions during drug development. Performing formal stability studies (including long term studies --> 12 months and accelerated stability studies --> 6 months) is required before submission of the drug’s dossier to regulatory authorities. The duration of these stability studies makes the situation untenable when aiming to develop stability-indicating analytical methods. These are methods which are used to quantitate the decrease of the active pharmaceutical ingredient (API) over time due to degradation and the subsequent increase of degradants. Thus, to save time, an analyst is faced with the necessity to artificially generate degraded samples and API is forced degraded. Therefore, it is stressed by different means such as subjecting it to acid, base, oxidants, heat, humidity and light and then analyzing the degradants. There are two basic aspects of the drug that are considered afterwards:

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