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- Do You calculate Linearity properly?
Imagine the following situation. You are testing the linearity of an analytical method, let’s say HPLC. The linearity coefficient is R=0.999, the coefficient of determination is R2 = 0.999. An ideal situation. The criteria are met, the validation is successful. Now all that’s left is to write the report and go home. Nothing could be… - When to conclude the development of an analytical method?
How do you know when to stop optimising your analytical method? This question was asked during one of the training sessions I was giving. Although I knew the answer, it still surprised me. Because it’s not obvious at all. - Quality by Design in Drug Products Development
Quality by design (QbD) is a concept that has become firmly established in the pharmaceutical and biotechnology world. The ICH, FDA and EMA have been working on the implementation of QbD in the life cycle of medicinal products for many years, resulting in the ICH Q8, Q9 and Q10 guidelines. However, it did not stop… - Fault Tree Analysis
Risk analysis is an integral part of working in the pharma and biotech industry. The ICH Q9 guideline describes exactly what it is used for and what risk analysis tools are proposed. Some of the most popular are FMEA, RRF, PHA, Ishigava diagram, HACCP etc. A few months ago, for a consulting project, I started…
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