Glossary

Internal validity in a clinical trial is the ability of the trial to reach the correct conclusion about whether or not, and to what extent, a treatment is causing a measured effect on the participants. It implies accurate and unbiased measurement of that effect.

Internal validity is achieved when possible alternative explanations for the measured effect can be excluded, such as chance or bias. Well-designed clinical trials take this into account, for example by using randomisation and blinding.

Formerly the International Conference on Harmonisation. The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) produces harmonised guidelines for global pharmaceutical development, and their regulation. It brings together the regulatory authorities and the pharmaceutical industry from five regions (Europe, Japan, USA, Canada and Switzerland).

ICH has been established in order to reduce the duplication of clinical trials and create a more streamlined regulatory assessment process for new applications. As such, ICH has developed four sets of guidelines provided for specific topics including quality, safety, efficacy and multidisciplinary (e.g. ICH medical terminology (MedDRA), or the Common Technical Document (CTD)) which are implemented by the regulatory authorities of its membership.

International Federation of Pharmaceutical Manufacturers and Associations

International Network of Agencies for Health Technology Assessment http://www.inahta.org/"

An International Non-proprietary Name (INN) is an official generic name given to a pharmaceutical compound. INNs facilitate communication by providing a standard name for each substance in the market with more than one brand name. Each INN is a unique name that is globally recognised and is public property. A Non-proprietary Name is also known as a generic name. Examples of INNs are: ibuprofen, mefloquine, and diazepam.

International Society for Pharmacoeconomics and Outcomes Research http://www.ispor.org/"

In medicine, intervention is an action which changes the outcome or course of a condition or disease so as to prevent harm or improve health through the use of treatments, medicinal products, medical devices or procedures/surgery.

An interventional study is one in which the participants receive some kind of intervention, such as a new medicine, in order to evaluate it. In the medicines development process, medicines are evaluated through interventional studies known as clinical trials.

There are many variations in how clinical trials are designed, but they are commonly randomised (participants are allocated to different arms in the study randomly) and controlled (the study medicine is given to one arm, and the outcomes are compared with an alternative treatment or placebo given to another arm). These are called randomised controlled trials, or RCTs.

Intravenous means ˜within the vein™. It is the infusion of liquid directly into a vein using a syringe or intravenous catheter (tube).

Compared with other routes of administration, the intravenous route is the fastest way to deliver fluids and medicines into the blood stream (the systemic circulation). In intravenous therapy, the bioavailability of the medication is 100%.

An investigational medicinal product is an active ingredient or placebo that has been pharmaceutically formulated (prepared) for human use which is being tested, or used as a comparator, in a clinical trial.

Typically IMPs have not yet received marketing authorisation, however in some circumstances they may be products that have been authorised:

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• when they have been made using a different formulation than that which is authorised (e.g. different dose),
  
• when the authorised product is to be used as the test substance or comparator in a clinical trial,
  
• when used for an unapproved indication (off-label), or
  
• when used to gain further information about an approved use.