GC: n
S: EMA – http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000330.jsp&mid=WC0b01ac058002956b (last access: 8 December 2015); FDA – http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm261078.pdf (last access: 8 December 2015).
N: 1. – drug (n): Middle English drogge. First Known Use: 14th century.
– substance (n): Middle English, from Anglo-French, from Latin substantia, from substant-, substans, present participle of substare to stand under, from sub- + stare to stand.
2. drug substance.
- An active ingredient intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body; it does not include intermediates used in the synthesis of such an ingredient.
3. drug substance.
- The main ingredient in a medicine that causes the desired effect of the medicine.
- Some medicines contain more than one drug substance that act in different ways in the body.
- Also called active pharmaceutical ingredient, API, and pharmacologic substance.
4. Pharmaceutical Manufacturing: drug substance.
- Source: The Structure of a Veterinary New Drug Submission (Canada).
5. Medication; Pharmaceutical Manufacturing: active principle, active substance, active ingredient, active pharmaceutical ingredient, API.
- A constituent of a drug, usually an alkaloid or glycoside, on which the characteristic therapeutic action of the substance largely depends.
- Some authors differentiate “active substance” and “active principle” from “active ingredient”, the first two referring to compounds at the beginning of the drug cycle production and the latter being obtained at the end of this cycle.
S: 1. MW – http://beta.merriam-webster.com/dictionary/drug; http://beta.merriam-webster.com/dictionary/substance (last access: 8 December 2015). 2. TFD – http://medical-dictionary.thefreedictionary.com/Drug+Substance (last access: 8 December 2015). 3. NIH – https://www.cancer.gov/publications/dictionaries/cancer-terms/def/drug-substance (last access: 19 January 2025). 4 & 5. TERMIUM PLUS – https://www.btb.termiumplus.gc.ca/tpv2alpha/alpha-eng.html?lang=eng&i=1&srchtxt=drug+substance&index=alt&codom2nd_wet=1#resultrecs, https://www.btb.termiumplus.gc.ca/tpv2alpha/alpha-eng.html?lang=eng&i=1&srchtxt=principe+actif&index=alt&codom2nd_wet=1#resultrecs (last access: 19 January 2025).
SYN: active principle, active substance, active ingredient, active pharmaceutical ingredient, API. (depending on context).
S: TERMIUM PLUS – https://www.btb.termiumplus.gc.ca/tpv2alpha/alpha-eng.html?lang=eng&i=1&srchtxt=principe+actif&index=alt&codom2nd_wet=1#resultrecs (last access: 19 January 2025)
CR: amphetamine, antiaggregant, contraceptive, drug, drug product, drug therapy, fentanyl, hallucinogen, LSD, infusion, medication, methylenedioxymethamphetamine, narcotic (2), pharmacology, placebo, placebo effect, psychotropic drug, sleeping pill, target cell.
