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Before you can begin to develop a method, you must be clear about the information and the quality of the data you want to obtain from a sample. This very often determines the possible techniques and methods that can be used...
Global regulatory authorities continue to push Quality-by-Design (QbD) on pharmaceutical groups and their supporting corporate informatics infrastructure...
This new handbook is designed to help you navigate through the different measurement techniques, method parameters and sample preparation procedures. The aim is to provide you with useful tips and hints on how to obtain the best possible results from your measurements...
The counterfeiting of pharmaceuticals for economic gain is a growing problem in a modern society within which medicines play a major role...
In this handbook, collected applications for pharmaceuticals are examined...
Continuous manufacturing approaches have been gaining interest in the pharmaceutical industry. They allow shorter production times, enable novel reaction pathways, increase assurances of product quality and help to realise cost savings...
Mass spectrometry is an extremely sensitive method for the detection and identification of traces of gaseous substances. The technique can quantify atoms or molecules and provide chemical and structural information (functional groups and side chains) on the compounds analysed...
Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
It is important to realise early in your project that if you are validating a computerised system, you do not just concentrate on the computer hardware and software. Validation encompasses more, as will be discussed within this handbook...
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
For quantitative results, the curves obtained from the measurement instrument have to be properly evaluated. Often, several different procedures are available for calculating numerical results from the curves...
Pharmaceutical tablets are coated for a variety of reasons, such as to enhance the appearance, taste, chemical stability, or swallowability of the tablet or to create a particular release profile for the active pharmaceutical ingredient (API)...
For the study of a pharmaceutical drug product, particle characteristics (count, size and chemistry) and compound distributions (size and spatial) are among key parameters that strongly determine the quality of the product...
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing...
For certain product types, there is a requirement for testing to determine the absence of certain microorganisms...
