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Outsourcing offers pharmaceutical companies many benefits. For example, contract development and manufacturing organisations (CDMOs) possess specialised expertise, knowledge and capabilities in the areas required for the development and manufacture of drug products.

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Inhaled products represent one of the most effective strategies to deliver therapeutic concentrations directly to the site of treatment.

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Progressing a drug from early phase development to first in human (FIH) trials often presents a complex challenge in which there are many potential pitfalls. In fact, a poor safety profile leads to almost two thirds of projects being cancelled in their early stages.

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Despite the delay to Brexit, pharmaceutical companies still have limited guidance on the regulatory landscape following the UK’s exit from the European Union (EU).

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When drug products are transferred from the UK to the EU market, they will still need to comply with FMD requirements.

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There are many reasons why oral solid dosage (OSD) forms remain the most popular, including their cost effectiveness, patient-friendly nature and ability to extend product lifecycles by implementing extended, controlled and rapid release formulations.

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Orally inhaled drug products offer many therapeutic advantages over other dosage forms, the primary advantage being a direct delivery to the central nervous system. As such, drug developers can produce delivery strategies that reduce the chances of patients experiencing adverse effects.

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There is a growing interest among drug developers and manufacturers in the use of modified release (MR) oral dosage forms. MR formulations offer formulation scientists and patients many advantages, such as improved efficacy, increased convenience and optimised performance.

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Källsten, M., Pijnappel, M., Hartmann, R. , Lehmann, F., Kovac, L., Bergström Lind, S.  and Bergquist, J Analytical and Bioanalytical Chemistry (2019)

Insights

The United Kingdom (UK) will leave the European Union (EU) on 29th March 2019. The steps and measures pharmaceutical firms take at this stage will be critical to post-Brexit preparedness, failure to take action could ultimately impact the supply of medicines and patient safety.