Terms Related to Adverse Drug Reactions

Terms that may be included as Adverse Drug Reactions (ADRs) are side effects, drug intolerance, idiosyncratic reactions, toxic reactions, allergic reactions, or hypersensitivity reactions.

Side effects are reactions that are unintended and unwanted but are known pharmacologic effects of the drug and occur with predictable frequency.

Drug intolerance is a mild reaction to a drug that results in little or no change in patient management.

Idiosyncratic reaction is an unexpected response that occurs with usual dose of a drug.Toxic reactionis predictable response that results from greater than recommended drug dosages or drug concentration in the body.

Allergic or hypersensitivity reaction is an unusual sensitivity to a drug of an immunologic nature.

Opportunities and Limitations of Biopharmaceuticals

Biopharmaceuticals are attractive as drugs because they represent naturally derived products for treatment of disease. However, the complexities of the manufacturing process, and the drugs themselves, represent some major challenges in their development and formidable limitations to their widespread use. Even if biotechnology can now successfully produce large quantities of the pure protein, controlling its 3D structure during manufacturing, handling, and storage is critical to safety and efficacy. Delivering the protein to the patient in a safe, accurate, convenient, and reproducible manner is difficult. Even if these problems are overcome, the body often treats proteins differently than it treats small molecules, limiting their use.