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The European Union’s good manufacturing practice (GMP) guide for sterile products, known as Annex 1, has been subject to many changes since the first version was published in 1971.

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Understanding the solution chemistry of the systems evolving from complex multidrug amorphous formulations continues to be a grand challenge in field of drug development of fixed dose combinations (FDCs). In this article, we contribute to advancing the knowledge of FDC formulations by rationalizing the solution behavior of drugs during dissolution and supersaturation.

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Q1. Why is it even important for pharma to be a sustainable industry? Surely healthcare is so important to people, literally vitally so, that pharma gets a free pass when it comes to its environmental impact?

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Analytical chemistry’s role in drug development is to provide assurance of the quality, safety, and efficacy of new medicines. The effectiveness with which these analytical requirements are carried out can also have a marked impact on the speed that a product is ready for market.

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The most significant impact on the environment comes from commercial scale pharmaceutical manufacturing.

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Many now realise the benefits that working with a contract provider with specialist expertise in analytical testing can offer in terms of accelerating timelines. 

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In recent years, there has been increasing concerns around drug supply shortages and discussions around the potential benefits of relocating medicine production back to the EU.

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Featured in a roundtable with On Drug Delivery, Recipharm’s Senior Director, Technology and Strategic Investments, Torkel Gren, speaks about the different dosage forms and administration routes available to drug developers, referencing some of the key trends in the sector.

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In recent years there has been a change in focus for drug formulators as it becomes more critical that the needs of the patient are considered when developing new drug products. The focus on the overall patient experience is a priority now, particularly as specific dosage forms can have a different impact on the user and their ability to take medications effectively or correctly. 

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The outbreak of COVID-19 has had a mixture of effects on the injection delivery market. For example, some patients have delayed their care for fear of going into healthcare settings for treatment and potentially contracting the disease.