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Insights

Pharmaceutical firms are increasingly interested in developing inhaled and nasal delivery formulations. Among many other benefits, administrating drugs via inhalation can reduce the likelihood of patients experiencing adverse effects.

Insights

There is no substitution for experience when it comes to taking substances from pre-clinical to clinical and then to commercial scale. 

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A drug substance project’s movement from pre-clinical to clinical and then into commercial scale manufacture often presents challenges which can lead to failure.

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Many companies underestimated the complexity of implementing serialisation solutions.

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

Insights

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.

Insights

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.