Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Placebos

Placebos are an important tool in clinical trials that allow researchers to accurately assess the efficacy and safety of new therapeutic procedures.

Placebos are products that look like a drug but do not contain an active pharmaceutical ingredient. Placebos can also resemble therapeutic measures whereby no actual intervention is carried out. Placebos are sometimes used in clinical trials (German translation: klinische Studien) to assess the efficacy of a treatment.

The most important characteristics of placebos:

  • Inactivity: Placebos do not contain active pharmaceutical substances that can cause physiological changes in the body in connection with the treatment of a specific disease.
  • Placebo effect: Despite the absence of active pharmaceutical ingredients, placebos can bring about an improvement in a patient’s condition that can be attributed to psychological factors, among other things. This phenomenon is known as the placebo effect (German translation: Placeboeffekt), whereby the patient’s expectations of the treatment lead to physical or emotional changes, among other things. Doctor-patient communication is an important factor.
  • Use in clinical studies: Placebos are often used in controlled clinical trials to evaluate the efficacy of a new drug. Comparing the results between the verum group and the group receiving the placebo helps to determine whether the observed effects are due to the drug itself.
  • Double-blind study: Ideally, the placebo is used in a double-blind study (translation into German: Doppelblindstudie) in which neither the study participants nor the researchers know who is receiving the verum and who is receiving the placebo. This reduces the risk of subjective bias in the study results.
  • Safety: Since placebos do not contain any active therapeutic components, they are considered safe. However, their use in research requires ethical considerations, particularly in cases where an effective standard treatment that patients are deprived of when placebos are used is available. In these cases, the study participants in the control group receive the standard therapy.

Placebos are an important tool in clinical trials for accurately assessing the efficacy and safety of new therapeutic procedures.

As pharmaceutical interpreters and GMP translators, we support you during GMP inspections by regulatory authorities such as the American FDA or the Russian SID&GP (GILS i NP), be it in the course of preparation and follow-up with pharmaceutical translations or on site as interpreters.

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