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).

Pharmacokinetics

Pharmacokinetics describes the processes that occur when drugs enter the body, how quickly and in what quantity they enter the blood and tissues, and how long they remain in the body.

Pharmacokinetics is a branch of pharmacology that studies how the body absorbs, distributes, metabolizes and excretes drugs after they have been administered. Absorption, distribution and excretion are important steps in this process. Pharmacokinetics describes the processes that occur when drugs enter the body, how quickly and in what quantity they enter the blood and tissues, and how long they remain in the body.

The most important aspects of pharmacokinetics (German translation: Pharmakokinetik) include:

  • Absorption: This process determines how quickly and to what extent a drug is absorbed by the body surface, which includes the mucous membrane of the gastrointestinal tract, after application. Factors like the dosage form (tablet, capsule, cream, etc.) or the solubility of the active pharmaceutical ingredient can affect the absorption rate (translation into German: Resorptionsrate).
  • Distribution: This step describes how the API is distributed in the tissues and organs of the body after it has entered the bloodstream. Distribution (German: Verteilung) may depend on the physical and chemical properties of the active pharmaceutical ingredient as well as the patient’s physiological characteristics.
  • Biotransformation: The biotransformation of active pharmaceutical ingredients is the process of their chemical conversion in the liver and other organs. Biotransformation can impair the effect of a drug and its safety, as it can lead to the formation of active or toxic metabolites.
  • Excretion (German: Ausscheidung): This step describes how the body excretes active pharmaceutical ingredients via the kidneys, liver, intestines and other organs. The excretion processes can vary depending on the API and the patient.
  • Half-life: This is the period in which the plasma concentration of the active pharmaceutical ingredient falls to half of its initial value. The half-life helps to determine dosing intervals.

Pharmacokinetics is important for determining the optimal drug dosage, predicting the efficacy and safety of drugs and for clinical-pharmacological research. This discipline also accounts for individual patient characteristics such as age, sex, genetic factors and the presence of diseases that can influence pharmacokinetic processes.

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