Pharmacists provide an invaluable interface in this process by liaising with scientists and clinicians across the development arena.
During the discovery research phase of development of a medicine pharmacists will work with other scientists to develop and select drug compounds that may be valuable as medicines. They will also help the project team, which might include medicinal chemists, bioscientists, toxicologists, pharmacokineticists and others, to understand the biopharmaceutical properties of the compound, the dosage form and how the route of administration might affect the rate and extent of absorption. In this area a post-graduate qualification is a particular asset.
Formulation and packaging development
A large number of pharmacists in the industry work in the areas of formulation and packaging development. A drug substance can only be useful as a medicine when it is in a form that can be manufactured on a large scale, distributed and administered satisfactorily.
Highly specialised formulations such as targeted release and skin patches can enhance the effectiveness of the drug and sophisticated packaging can aid administration and acceptability of the product and deter fraud. For exports, and of course for veterinary pharmaceuticals, different markets demand different formulations and packaging.
New products often require new analytical methods and developing these for new products is an important part of the overall development process. The pharmacy training, including the pre-registration part involved with patients, equips the pharmacist with many skills relevant to these activities.
Within clinical research, pharmacists can help assess the safety and efficacy of new medicines. Skills learnt during pharmacy training allow them to contribute to the entire clinical trial process from planning the trial, developing the prototype formulations for administration first in animals and later for trials in humans, the production, packaging, labelling and supply of the medicine to clinical researchers, through to the monitoring and reporting of complex studies.
If the drug performs well in trials and is nominated to go into full-scale commercial production, the process development team will be involved with the s scale up and technology transfer to one or more manufacturing sites. This is another area where many pharmacists are employed.