Science & Technology in Action

8th Edition

Lifecycle of a Pharmaceutical Product


This lesson describes the modern drug discovery process. It begins with understanding the underlying cause of disease and then identifying drug candidates that target specific cellular pathways involved in the disease process.
Download Lesson Kit

Contains the full lesson along with a supporting toolkit, including teachers’ notes.

Lesson excerpt

Where do new drugs come from?
In a leading pharmaceutical company such as Pfizer, scientists are continually studying the characteristics of specific diseases. They are attempting to find out whether there are any substances (e.g. particular chemicals) that could affect these characteristics and bring about an improvement or a cure.

We are familiar with the fact that we can get medicines from the pharmacy and that we need a doctor’s prescription for certain types of medicine. We can even purchase certain products without a prescription in supermarkets, health stores and on the internet. We may not realise that it can cost over 1 billion and take more than 10 years to ensure that a new drug is both safe and effective before it is marketed to the public. This long and involved process is called the drug discovery and development process. We will now view this process in some more detail.

Complex Molecules
Drug molecules are complex, and most of them consist of many hydrogen and carbon atoms, together with some other atoms. Examples are:

  • Aspirin (acetylsalicylic acid, C9H8O4)
  • Penicillin, the famous antibiotic (C16H18N2O5S)
  • Tacrolimus, an immunosuppressant used to prevent the rejection of transplanted organs (C44H69NO12)
  • Amlodipine, used for treatment of coronary artery disease and angina (C20H25ClN2O5)

True or False?

  1. Quality Assurance is the same as Quality Control. false
  2. The authority overseeing the development and marketing of medicines in Ireland is the IMB true
  3. All medicinal drugs require a prescription before they can be purchased. false
  4. Most drugs that are discovered are suitable for human use. false
  5. The science of establishing whether a drug is harmful to humans is called toxicology. true
  6. In vitro tests are carried out on living organisms. false
  7. Pre-clinical trials are carried out after the drug is administered to human beings. false
  8. GMP stands for Good Manufacturing Practice. true
  9. Pfizer has only one plant in Ireland. false
  10. Drug molecules are considered to be simple. false
  11. A procedure used to investigate a substance in the lab is called an assay. true
  12. No useful drug has ever been discovered by accident. false

Glossary of terms

Aspirin (acetylsalicylic acid)
clinical trial
drug discovery and development
fit for purpose
Food and Drug Administration (FDA)
Good Manufacturing Practice (GMP)
in vitro
in vivo
Irish Medicines Board (IMB)
Quality Assurance (QA)
Quality Control (QC)
Right First Time