Investigational drugs

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A clinical trial samples , even investigational , English Investigational Medicinal Product (IMP) or Investigational New Drug (IND), in the pharmaceutical research uses. These are forms of drugs or placebos that are tested in a clinical trial on humans or used as comparator preparations or used to produce certain reactions in humans.

definition

Investigational drugs can be drugs that are not approved , but also approved drugs if they are in a clinical trial on humans

  • in a dosage form other than the approved one or
  • for a non-approved field of application or
  • to obtain additional information about the approved medicinal product or
  • as a comparator in a study with drugs that have not yet been approved

can be used.

Manufacturing

In the EU , the manufacture of investigational medicinal products is subject to approval and is subject to the rules of “Good Manufacturing Practice” , in particular Appendix 13 of the Guidelines for Good Manufacturing Practice for Medicinal Products and Investigational Medicinal Products . The import of investigational medicinal products that have been manufactured outside the EU also requires a permit.

The manufacture and packaging of test drugs is usually technically more difficult than for approved drugs. Reasons for this are:

  • the often incomplete experience with the physical nature of the test drug,
  • the great variety of test arrangements in clinical studies,
  • the need for packaging that ensures the blinding that is often required in clinical studies and excludes cross- contamination between investigational medicinal products to be compared or mix-ups,
  • the often existing need for multilingual labeling in today's mostly international clinical studies,
  • the small batch sizes that often make automation uneconomical

For this reason, some investigational drugs are still made by hand today.

Labelling

In the EU, the labeling of investigational medicinal products is subject to the regulations of good clinical practice . It is intended to help protect the study participants . To this end, it should ensure traceability, enable identification of the medicinal product and the study and contribute to the correct use of the medicinal product.

In Germany and Austria, the following information, among other things, must therefore be given on the outer packaging in a legible, generally understandable manner in German and in a permanent manner:

  • Name, company, address and telephone number of the study sponsor and that of his contractor ,
  • Name and drug content of the investigational product (or a corresponding code in the case of blinded studies)
  • Batch designation with the abbreviation "Ch.-B."
  • Dosage form and content according to weight, volume or number of items
  • Type of application
  • Dosage instructions with single or daily doses
  • durability
  • Test plan number
  • the number assigned by the European database EudraCT
  • individual identification code for the study participant
  • an indication that the medicinal product is only intended for clinical testing
  • if necessary, storage or storage instructions
  • if applicable, a note that the test product should be kept out of the reach of children
  • If necessary, special precautionary measures for the disposal and return of unused investigational medicinal products and to avoid damage to fellow human beings or the environment

Some of this information can also be included in an accompanying document given to study participants.

The rules applicable in Switzerland are based on the EU guidelines.

During the COVID-19 pandemic , a statutory ordinance of the Federal Ministry of Health was issued in Germany in May 2020 , which authorizes the higher federal authority responsible under Section 77 of the Medicines Act to allow exceptions to the regulations on the labeling of investigational medicinal products in individual cases, provided that it is a Medicines for the prevention, diagnosis or treatment of COVID-19 are traded ( § 8 Abs. 1 MedBVSV). However, this exception only applies until the determination of the epidemic situation of national scope by the Bundestag or until March 31, 2021 at the latest ( Section 5 (4) sentence 1 IfSG).

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