English vocabulary for the pharmaceutical industry with common abbreviations

If you work in the pharmaceutical industry, learning the specialized vocabulary of the pharmaceutical industry is essential for several practical and professional reasons. These terms aren’t just jargon—they’re the language that ensures clarity, precision, and safety in a field where mistakes can have serious consequences.

Drug development and discovery

• Active pharmaceutical ingredient (API): The biologically active component of a drug product.
• Bioavailability: The proportion of a drug that enters the circulation and is able to have an active effect.
• Biologics license application (BLA): Application to the FDA for approval of a biologic product.
• Clinical trials: Research studies that evaluate the safety and efficacy of new drugs or treatments in humans.
  • Phase 0: Exploring how a drug or device may work. Few doses used in few people.
  • Phase 1: Small group, safety focus.
  • Phase 2: Larger group, efficacy and side effects.
  • Phase 3: Large, diverse group, confirm efficacy and monitor adverse reactions.
  • Phase 4: Post-market surveillance.
• Dosage: The amount of drug administered.
• Drug target: The molecule or structure a drug interacts with to produce a therapeutic effect.
• Efficacy: The ability of a drug to produce the desired therapeutic effect.
• Excipient: Inactive ingredients in a drug formulation that serve as carriers or bulking agents.
• Formulation: The form in which a drug is presented (e.g., tablet, capsule, injection).
• High-throughput screening (HTS): Automated testing of large numbers of compounds to identify potential drug candidates.
• Investigational new drug (IND): Application to the FDA to begin clinical trials.
• Lead compound: A promising chemical structure that may become a drug.
• New drug application (NDA): Application to the FDA for approval to market a new drug.
• Pharmacodynamics (PD): The study of biochemical and physiological effects of drugs on the body.
• Pharmacokinetics (PK): The study of how the body absorbs, distributes, metabolizes, and eliminates drugs.
• Placebo: An inactive substance used as a control in clinical trials.
• Preclinical trials: Studies conducted in vitro (in test tubes or cells) and in vivo (in animals) before human testing.
• Toxicology: The study of the adverse effects of drugs or chemicals on living organisms.

Manufacturing and quality

• Adverse drug reaction (ADR): An adverse event that is directly caused by a drug.
• Adverse event (AE): Any undesirable experience associated with the use of a drug.
• Batch: A specific quantity of a drug produced during a single manufacturing run.
• Dosage form: The physical form of a drug (e.g., oral, tablet, capsule, injection, syrup).
  • Buccal administration: The drug is placed between the cheek and gum, where it dissolves and is absorbed through the oral mucosa.
  • Capsule: A drug encased in a gelatin shell, typically for oral administration.
  • Inhalation: The drug is breathed into the lungs, where it is absorbed into the bloodstream or acts locally.
  • Injection: The act of introducing a liquid drug into the body through a hollow needle piercing the skin or other tissues.
  • Intramuscular administration (IM): The drug is injected into a muscle, where it is absorbed into the bloodstream over time.
  • Intranasal administration: The drug is sprayed or inhaled into the nasal cavity, where it is absorbed through the nasal mucosa.
  • Intrathecal administration: The drug is injected into the spinal canal or cerebrospinal fluid, targeting the central nervous system.
  • Intravenous administration (IV): The drug is injected directly into a vein, allowing immediate entry into the bloodstream.
  • Otic administration: The drug is applied to the ear canal, usually for local treatment of ear conditions.
  • Ophthalmic administration: The drug is applied to the eye, typically for local effects on the eye itself.
  • Oral administration: The drug is taken by mouth and swallowed, passing through the digestive system before entering the bloodstream.
  • Rectal administration: The drug is inserted into the rectum, where it is absorbed through the rectal mucosa.
  • Subcutaneous injection (SC or SubQ): The drug is injected into the fatty tissue just beneath the skin.
  • Sublingual administration: The drug is placed under the tongue, where it dissolves and is absorbed into the bloodstream through the mucous membranes.
  • Syrup: A thick, sweet liquid containing a drug, where the active ingredient is either dissolved (forming a solution) or suspended (forming a suspension) in a vehicle like sugar syrup or an artificial sweetener.
  • Tablet: A solid dosage form of a drug, often compressed into a small, round shape.
  • Topical administration: The drug is applied directly to the skin or mucous membranes for local effect (or sometimes systemic absorption).
  • Transdermal administration: The drug is delivered through the skin via a patch or device for systemic absorption.
  • Vaginal administration: The drug is inserted into the vagina, typically for local treatment or systemic absorption.
• Excipient: An inactive substance used as a carrier or stabilizer in a drug formulation.
• Good manufacturing practice (GMP): Regulations for ensuring the quality and consistency of drug manufacturing.
• Lot number: A unique identifier assigned to a batch of drug product.
• Orphan drug: A drug developed to treat a rare disease, often with regulatory incentives.
• Patent: Legal protection granting exclusive rights to produce and sell a drug for a set period.
• Quality control (QC): Testing and inspection to ensure products meet quality standards.
• Quality assurance (QA): Systemic processes to ensure quality throughout the manufacturing process.
• Sterile: Free from living microorganisms.
• Stability testing: Assessing how a drug’s quality changes over time under different conditions.
• Validation: Documented evidence that a process or system consistently produces a product meeting predetermined specifications.

Regulatory and business

• Clinical research organization (CRO): Companies that provide support for clinical trials.
• Contract manufacturing organization (CMO): Companies that manufacture drugs on behalf of other companies.
• Counterfeit drug: A fake or illegally produced drug misrepresenting its identity, composition, or source.
• European Medicines Agency (EMA): European agency responsible for regulating drugs.
• Food and Drug Administration (FDA): U.S. agency responsible for regulating drugs and medical devices.
• Generic drug: A copy of a brand-name drug with the same API.
• Healthcare provider (HCP): Doctors, nurses, and other medical professionals.
• Intellectual property (IP): Patents, trademarks, and copyrights protecting drug inventions.
• Labeling: Information provided with a drug, including dosage, usage, and safety information.
• Managed care: Systems that integrate the financing and delivery of healthcare.
• Over-the-counter (OTC): Drugs available without a prescription.
• Patent: Exclusive rights granted for an invention.
• Pharmacovigilance: The monitoring of drug safety after marketing.
• Prescription drug (Rx): Drugs requiring a prescription from a healthcare professional.
• Reimbursement: Payment for healthcare services, including drugs.
• Supply chain: The system of organizations, people, and activities involved in delivering a drug from manufacturer to consumer.
• Wholesaler: A company that purchases drugs in bulk and distributes them to pharmacies or hospitals.

Therapeutic areas

• Therapeutic: Relating to the treatment or healing of a disease or condition.
• Common therapeutic areas include: Oncology (cancer), Cardiology (heart disease), Neurology (brain and nervous system), Immunology (immune system), and Endocrinology (hormones).
• Analgesic: A drug that relieves pain (e.g., ibuprofen).
• Antibiotic: A drug used to treat bacterial infections.
• Contraindication: A condition or factor that makes a particular treatment or drug inadvisable.
• Side effect – An unintended reaction to a drug, often mild but sometimes serious.
• Vaccine – A biological preparation that provides immunity to a specific disease.

For more medical vocabulary see the post, “Medical doctor vocabulary“.