Drug safety is a characteristic of a drug that is based on a comparative analysis of its efficacy and the risk of harm to health (benefit-risk assessment).

The safety of a drug (German translation: Unbedenklichkeit) refers to the measures taken to minimize the risks and ensure the drug can be used by patients safely and effectively. It is an important aspect in the development, manufacture and use of drugs and encompasses many aspects. Here are some of them:

• Toxicity: The assessment of the toxicity (German: Toxizität) of a drug helps to determine which doses are safe for patients and which doses can cause adverse drug reactions or even toxic reactions. This includes animal testing and clinical studies on humans.
• Dosage: The determination of the correct dosage for safe and effective treatment is of crucial importance. Ideally, the dosage should be determined on the basis of sex, age, weight and other individual patient characteristics.
• Interactions with other drugs: Many patients take several drugs at the same time. It is therefore important to check how the drug interacts with other drugs in order to avoid adverse interactions (translation into German: Wechselwirkungen).
• Allergic reactions: Drugs can cause allergic reactions (German: allergische Reaktionen) in some patients. The assessment of the risk of allergic reactions and their prevention both play an important role in drug safety.
• Side effects: Drugs can cause side effects with varied levels of severity. It is important to assess and document these effects in order to develop strategies to minimize them.
• Stability: Drugs must remain stable for the duration of their shelf life to ensure their efficacy and safety.
• Delivery and storage: The proper storage and delivery of drugs in compliance with certain temperatures and other conditions plays an important role in preventing the degradation of active pharmaceutical ingredients in drugs and maintaining drug safety.
• Patient education: An important part of drug safety is informing patients about the correct and safe use of the drug, including how to take it, possible side effects and what to do if problems occur.

Drug safety is a crucial aspect in protecting patients’ health. Pharmaceutical companies, regulatory authorities and healthcare professionals work together closely to ensure that drugs on the market meet high safety and efficacy standards.

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