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Quality by Design (QbD)

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Medicine delivery by drone – implications for safety and quality

20 November 2019 | By ,

Drones that transport medicines to emergency situations, urban environments or geographically-challenging locations are increasingly being utilised to improve delivery, however, there are few studies on their impact on drug stability. Here, Paul Royall and Patrick Courtney explore the implications of drone delivery on the safety and quality of medicines.

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ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management

11 November 2019 | By

The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.

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European Pharmaceutical Review Issue 2 2019

25 April 2019 | By

This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…

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The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying

18 January 2019 | By ,

Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…