Chapter CIRD81920
| Published date | 11 March 2016 |
| Record Number | CIRD81920 |
| Court | HM Revenue & Customs |
| Issuer | HM Revenue & Customs |
Companies in the pharmaceutical industry that undertake research and development into potential new drugs have to conform to the regulatory processes of the countries in which they wish to market the drug. There are four basic stages in pharmaceutical R & D and these are summarised below.
The four basic stages 1. Drug DiscoveryThis is the earliest stage of the pharmaceutical research process, where potentially useful compounds (referred to as new chemical entities or NCE’s) are identified. This stage involves drug synthesis, biological testing and toxicology studies. Developments such as ‘high throughput screening’ (robotic screening systems that check thousands of molecules per day for particular characteristics), have aided this process tremendously. The process may involve searching huge ‘libraries’ of compounds for any that might have helpful biological activity - researchers can then select compounds for further testing.
2. Preclinical DevelopmentThis stage involves the initial development of candidate NCE’s. The NCE will be the subjects of further laboratory tests in vitro and on live animal subjects, to further establish its properties and effects. The company will be planning how it is to test and trial the NCE, how it is to source any substances it needs to produce sufficient quantities of the compound for trials, and how it is to approach the regulatory authorities. It will establish a structured and managed plan to test the compound and to present the compounds test data and report findings at the most optimal time and in the most appropriate format. At this point pharmaceutical companies usually give NCE’s a code name prior to selecting a brand name.
3. Clinical DevelopmentClinical trials are initiated when an NCE identified from laboratory research shows promise as a therapeutic intervention. Such potential drugs are tested on human subjects. This takes place in three stages. Phase I to III clinical trials are necessary before a medicine can be licensed as safe, effective and of good quality by the relevant regulator, for example the MCA (Medicines Control Agency - UK), EMEA (European Medicines Evaluation Agency - EU) or FDA (Food & Drugs Administration - USA).
- Phase I strategic work is often referred to as ‘situation analysis’. Investigations are conducted into how the drug is absorbed, how it is distributed to tissues, how it is metabolised and how it is excreted. This is assessed by administration to small numbers of healthy...
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