Safety pharmacology in pharmaceutical development and approval
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In drug development , preclinical development , also named preclinical studies and nonclinical studies , is a stage of research that begins before clinical trials testing in humans can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile.
Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools. On average, only one in every 5, compounds that enters drug discovery to the stage of preclinical development becomes an approved drug. Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamics what the drug does to the body PD , pharmacokinetics what the body does to the drug PK , ADME , and toxicology testing.
This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. Medical devices that do not have drug attached will not undergo these additional tests and may go directly to good laboratory practices GLP testing for safety of the device and its components. Some medical devices will also undergo biocompatibility testing which helps to show whether a component of the device or all components are sustainable in a living model. Typically, both in vitro and in vivo tests will be performed.
Studies of a drug's toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction. The information collected from these studies is vital so that safe human testing can begin. Typically, in drug development studies animal testing involves two species. The most commonly used models are murine and canine , although primate and porcine are also used.
The choice of species is based on which will give the best correlation to human trials. Differences in the gut , enzyme activity , circulatory system , or other considerations make certain models more appropriate based on the dosage form , site of activity, or noxious metabolites. For example, canines may not be good models for solid oral dosage forms because the characteristic carnivore intestine is underdeveloped compared to the omnivore's, and gastric emptying rates are increased.
Also, rodents can not act as models for antibiotic drugs because the resulting alteration to their intestinal flora causes significant adverse effects.
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Depending on a drug's functional groups, it may be metabolized in similar or different ways between species, which will affect both efficacy and toxicology. Medical device studies also use this basic premise. Most studies are performed in larger species such as dogs, pigs and sheep which allow for testing in a similar sized model as that of a human. If a CTA application is granted, the safety and pharmacology of a candidate drug will be tested first in a small group of healthy volunteers in a phase 1 trial. Small doses of the compound will be administered to a group of 20 to healthy volunteers who are closely supervised.
At least half of compounds will usually be considered safe enough to progress to phase 2 trials. Phase 2 studies examine the efficacy of a compound in volunteer patients who have the condition the drug is intended to treat. To avoid unnecessarily exposing a volunteer to a potentially harmful substance, these studies use the fewest number of patients possible to provide sufficient statistical power to determine efficacy, usually — patients, who are monitored and assessed continuously.
The aim of phase 2 studies is to determine the most effective dose and method of delivery for example, oral or intravenous , the appropriate dosing interval, and to reconfirm product safety. Most drugs that fail during clinical trials do so at Phase 2 because they turn out to be ineffective, have safety problems or intolerable side effects. Those candidates that make it through phase 2 will then be tested in a much larger population of patients in phase 3 trials, often 1, to 5, across multiple international sites.
The aim of these phase 3 trials is to reconfirm the phase 2 findings in a larger population and to identify the best dosage regimen. In doing this the drug company needs to generate sufficient safety and efficacy data to demonstrate an overall risk-benefit for the medicine to allow a submission to be made for a licensing application to the regulatory authority. The process of drug development and marketing authorisation is similar across the world.
For those drugs that make it to through phase 3, a submission for marketing authorisations is made to the national regulatory authority in most countries. However, in Europe, drug companies usually now opt to make a central application to the European Medicines Agency EMA in order to obtain marketing authorisation for the whole of Europe to avoid having to make multiple applications to individual countries.
The submission contains preclinical and clinical information obtained during testing, including information about the chemical makeup and manufacturing process, pharmacology and toxicity of the compound, human pharmacokinetics, results of the clinical trials, and proposed labelling. If a licence is granted, that is not the end of the process.
NICE makes its decisions based on the cost and efficacy of a treatment to determine whether the cost-benefit it offers to the NHS is affordable. Clinical trials may also continue. Regulatory authorities may insist on phase 4 trials for post-marketing safety surveillance pharmacovigilance or they may be undertaken by the company to enable them to target distinct markets.
For example, to enable the drug to be used in patients with complex medical problems or pregnant women who are unlikely to have been involved in earlier trials, and to ensure that they do not interact with other drugs. Pharmaceutical companies will patent any molecule that shows promise early in the development process.
Patenting prevents other companies copying it for 20 years and covers many aspects of the intellectual property of a drug, including its manufacture, formulation and, in some cases, its use. The purpose of a patent is to enable the pharmaceutical company that developed it to recoup their development costs and to make a profit to cover the development costs of drugs that failed during the testing process, as well as to invest in the development of future innovative drugs. By the time a drug has undergone the required testing and been licensed, half the patent period will usually have expired.
Once a patent on a drug has expired generic versions of the drug can be manufactured and marketed. For some drugs the period of patent protection can be extended for up to a further five-and-a-half years, so long as this does not take the time in which the drug is under patent protection beyond 15 years after the date it received regulatory approval. As drugs and their development have become more complex and expensive, so have the demands for information from the regulatory agencies.
In response, communication channels have opened up between drug companies and regulators well ahead of submissions to help ensure that companies are compiling all the relevant data required for a successful submission. The MHRA has set up a dedicated innovation office to provide advice and support to companies.
Its main focus is to aid new drug developers and companies developing unique products such as gene and cell therapy, nanomedicines, or treatments involving new delivery systems or produced through novel manufacturing processes. Meanwhile NICE offers a fee-based consultancy service to developers of medicines to help them ensure that they generate the evidence they will need to support a NICE evaluation.
NICE recommends that any advice is sought after the first human trials to aid planning of the more extensive trial programme. For every 25, compounds that start in the laboratory, 25 are tested in humans, 5 make it to market and just one recoups what was invested. The high cost of current drug development coupled with the trend towards complex medicines and use of genomic markers to predict drug response personalised medicines may mean that, in the future, we see a more flexible drug development process and regulatory framework.
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