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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. The result is efficient, cost-effective and high-quality (bio)pharmaceutical production. principles.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Regulation, particularly Annex 1, was identified as a key focus for 2022.

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Everything You Need to Know About Market Access in China

PM360

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. From 2017 to 2022, the Chinese market witnessed a growth rate of 5.3%, compared to the average market growth of 6.6%

Marketing 105
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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] Manufacturers, healthcare providers, and consumers alike face the need to quickly adapt.

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The Traditional Pharma Model Isn’t Working – It’s Time to Evolve!

PharmaKinnex

August 23, 2022. The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. PharmaKinnex has spent more than 18 years helping companies adopt new strategies, increase profitability, and expand their product reach. More convenience and safety?

Pharma 52
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The imperative of fridge-free vaccines

European Pharmaceutical Review

TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region. Injection Safety Fact Sheet. References What percentage of the world population lives in developing countries? Internet] Burak. cited 2023July].