Pharmaceutical Industry - Essay Example

Phase trials are primarily concerned with assessing the drug's safety and tolerability and are the first step in testing new investigational medicines in humans. The patients in these trials usually number 20-100 and the trials may last several months (ABPI 2006). However, prior to testing the drug in humans for the first time the following requirements have to be met: The study drug must have undergone preclinical research in the laboratories needs to be undertaken to determine which compounds will result in a chemical effect on the disease, and the drug compound will have to have been placed in a living biological system to check for safety in human disease, which involves testing the compound in at least two animals.

This is to ensure the safety of administering a new drug to health volunteers and patients (Novartis 2004). Prior to the therapeutic trials in patients, which is the Phase 1 trials, the pharmaceutical company will need to have: the preclinical testing data and findings from the laboratory studies, the manufacturing information, clinical protocols and investigator information in the form of an Investigator's Brochure which will contain all the information about the study drug (MHRA 2006). This information will be required by the licensing authority, which in the UK is the Medicines and Healthcare products Regulatory Agency as part of the application for a Clinical Trials Authorisation which would enable a trial to be conducted in humans.

In addition to this Authorisation, the pharmaceutical company will need to obtain a favourable ethical opinion and approval from the site where this drug will be tested. The development plan for this new active substance up and including the marketing authorisation application would include (EMEA 2006):Undertaking pre-clinical tests (laboratory and animal tests)If these tests are positive then an application to the MHRA will be made for a Clinical Trials AuthorisationThe application for a Clinical Trials Authorisation can be made alongside the application for an ethical opinion.

Once all required approvals are in place, the drug can be tested in a Phase 1 trial in healthy subjects. If the results of this trial are positive and no serious adverse events or suspected unexpected serious adverse events occur, then this progresses to a Phase 2 trial in subjects with the disease or medical condition.If the Phase 2 trial is successful and the drug shows an effect, it can progress to a Phase 3 trial and this where the drug is tested in a larger population that spans countries and ethnic groups.

If the Phase 3 trial is successful, the pharmaceutical company can apply for a Marketing Authorisation Application from the MHRA, details of which are included in the Appendix.The key issues that will need to be addressed in the clinical overview include the clinical profile of the drug, the pharmacokinetics and pharmacology, toxicology, the dose schedule, the control of the substance and adverse side effects (EMEA 2006). Other issues include the rights and safety of the study subjects, the duration of the clinical trial, the appropriateness of the facilities at the intended site, the experience and qualifications of the study investigators and staff, the administration and manufacturing of the study drug, the procedures for monitoring safety in terms of serious adverse events, the provisions for informed consent and the use of financial incentivesReferencesABPI (2006), The Association of British Pharmaceutical Industry, Clinical Trials, http://www.abpi.org.uk. Last accessed 28 June 2006.

EMEA (2006), The European Medicines Agency, http://www.emea.eu.int/pdfs/human/swp/9185006en.pdf. Page last accessed 28 June 2006.MHRA (2006), Medicines and Healthcare products Regulatory Agency, http://www.mhra.gov.uk. Page last accessed 28 June 2006.Novartis (2004) The drug development process at Novartis. http://www.nibr.novartis.com/OurScience/drug_development.shtml. Page last accessed 28 June 2006.