Pharmaceutical translations for pharmaceutical companies, drug importers or companies providing registration services on their behalf, first and foremost regard written translations of so called product information (Summaries of Product Characteristics – SPC, Patient Information Leaflets – PIL added to drug packages, and drug packaging Labelling), and drug registration dossiers, translated according to the CTD template. Moreover, these are also translations in terms of harmonization of medicinal products, i.e. translations of normalized amendments to the registration documentation in compliance with guidelines of EU Directives. Translations of the above documents are carried out based on EMEA terminology guidelines and glossaries in order to unify vocabulary according to pharmaceutical law.
Furthermore, written translations of documents regarding validation of analytical methods in pharmacy (certificates of analysis, registration certificates), specifications, results of qualitative and quantitative physicochemical tests of drugs, including bioequivalence studies, belong to this group. These are also marketing translations of: advertisement folders or films on drugs, social promotional events in the scope of health care, Power Point presentations, etc. Finally, these are translations of scientific content: abstracts prepared for scientific symposia, scientific books and articles, or simultaneous translations of conferences on pharmacology and pharmacoeconomic issues.
In this group of translations there are also translations of patent applications or documents for pharmacists applying for the recognition of their qualifications in EU member states, i.e. translations of a pharmacist’s diploma, a licence to practise a profession, a certificate of employment, etc. In turn, translations from the periphery of medicine and pharmaceutical science regard clinical study issues, i.e. studies on the safety and efficacy of drug use (e.g. PSUR – Periodic Safety Update Report). Selected documents that we have translated to date: CRF, patient’s diaries, study protocols, informed consent forms, applications to Central Register of Clinical Studies for the approval of clinical trial conduct, reports on adverse drug reactions and adverse events, and Standard Operating Procedures (SOP). Most commonly, pharmaceutical translations are carried out by pharmacists or medical doctors, including so-called clinical study monitors, sometimes also medical analysts, biomedical physicists, biologists and other competent persons who have completed studies in the field of life sciences and appropriate courses, e.g. “Introduction to Clinical Trial Monitoring”.
|Pharmacology, pharmacokinetics & pharmacodynamics;|
|Phytotherapy, herbs, pharmacognosy;|
|Drug form: tablet, capsule, pellet, powder, pill, globule, coated tablet, liposome, granulate, suppository, infusion fluid, suspension, decoction, infusion, extract, syrup, hydrogel, drops, ointment;|
|Prescription drugs (Rx.) and over-the-counter drugs (OTC);|
|Direct packaging: vial, ampoule, blister, sachet;|
|Original and generic drugs (generics);|
|Medicinal product: drug substance and excipients (a filler, a carrier);|
|Antibiotics of bactericidal and/or bacteriostatic action: beta-lactams (e.g. penicillins, cephalosporins), peptide antibiotics, aminoglycosides, tetracyclines, macrolides, linkosamides, rifamycins;|
|Cardiac drugs, hypnotic drugs, non-steroidal anti-inflammatory drugs (NSAIDs), homeopathic drugs, antidepressants, analgesics, antiviral agents, antiepileptic drugs;|
|Analgesics (symptomatic treatment of pain – pain receptor blockers);|
|Route of administration: inhalatory, oral (Per Os = p.o.), intravenous (i.v.), intramuscular (i.m.), subcutaneous (s.c.), intrarectal (Per Rectum = p.r.), sublingual, intra-conjunctival, intra-articular, etc.;|
|Antiviral agents: Acyclovir, Zovirax, beta interferon;|
|Sulphonamides & photosensitization;|
|Therapeutic, maintaining and lethal dose, bolus;|
|Monotherapy and combination therapy (polytherapy);|
|Drug interactions, undesirable effect (side effects of a drug action), Serious Adverse Event (SAE);|
|Selected technological functions of substances added to food, drugs and diet supplements, which have been approved by the Polish Ministry of Health: colour, preservative, emulsifier, thickener, gelling agent, stabilizer, anti-caking agent, raising agent, firming agent, bulking agent, carrier, enzyme, flavour enhancer, glazing agent;|
|The Hippocratic Oath, the Paracelsus’s Rule.|