Module 1-3

• Ancient Greece used opium as a drug.
• Ancient Egypt used Purgatives (laxatives) such as "senna" which is still used today.
• Ancient China used Ma Huang, a herb that treats cough, flu, fever, and is also used in modern medicine as an anthelmintic and decongestant.
• Poisons, including curare, are used in today's drugs.
• Ergot, a fungus that grows on rye bread, causes hallucinations, mental frenzy, convulsions, and cardiovascular and reproductive system effects.
• 95% of ethanol is metabolized in the liver by biotransformation.
• 5% of ethanol is excreted in urine, breath, and sweat.
• Ethanol is used to treat methanol poisoning.
• MD of Ergot includes Ergotamine and Ergonovine, both used in modern medicine to treat migraines by constricting blood vessels and to hasten birth.
• Drugs and religion are closely related.
• A drug is a substance not received for nutritional use and it influences biological functions.
• Two major drug discoveries are drugs that act on the brain (alter normal chemical signalling) and drugs that act against infectious diseases (penicillin).
• The five main stages of drug development process are drug discovery, drug development, clinical trials, post market surveillance, and basic research and discovery.
• Drug discovery takes 3-6 years and involves research & discovery, pre clinical trials, and basic research and discovery.
• Drug development takes 6-7 years and involves clinical trials, health canada and marketing review, and post market surveillance.
• Phase 1 of clinical trials evaluates safety and doses, with doses ranging from 1-2 and limits on participants of 20-80 healthy patients.
• Phase 2 of clinical trials evaluates effectiveness, with limits on participants of 100-500 diseased patients.
• Phase 3 of clinical trials evaluates safety and efficacy of drug compared to no treatment or golden standard, and is also used for licensing and marketing.
• Design of Phase 3 involves enrolment, treatment and allocation, and result analysis.
• Phase 3 enrolment entails the target population and the study population, with inclusion/exclusion criteria and consent.
• Statistics are used to compare data of experimental group vs control group.
• After clinical trials, the trial results are submitted to health Canada.
• Health Canada accepts clinical trials if they are effective and the toxicity is reasonable.
• The generic name of acetaminophen is Tylenol, which is patented for 20 years.
• Bioequivalents are generic and brand name drugs that must contain the same ingredients and give similar blood levels.
• Post Market Surveillance, also known as Phase 4 clinical trials, monitors adverse reactions reports and adds new labels, directions, etc.
• Drug Action 4 Factors include Drug target, Drug response, Efficacy and potency, and Therapeutic range.
• Drug targets can be receptors or other targets such as chemical reactions or physical chemical forces.
• A receptor is a molecule or complex molecule on a cell that has a role in many processes, both inside and outside cells, bound and activated by endogenous ligands.
• Drugs act on receptors by increasing the drug effect with increasing dose, and a low dose can have a desired response with many receptors activated.
• The threshold is the minimum concentration with maximum effect below which toxic response occurs.
• Efficacy is the maximum pharmacological response or ability, the ability of the drug to fix an issue, and is very important.
• Potency is the amount of drug that must be given to obtain a particular response and can be adjusted.
• The therapeutic range is the amount of a drug that can keep blood concentration of a drug above the minimum concentration with maximum effect but below toxic response.
• Pharmacokinetics define the movement of drug into, through, and out of the body.
• Administration can be Tropical (directly to a particular place on or in the body), Enteral (via GI tract, first to liver which lowers drug concentration), Parenteral (injected into the blood stream), or Sublingual and Buccal (under tongue, Gum, and cheek).
• After Administration, ADME determines the concentration in the blood which determines concentration at the action site.
• Parenteral Administration is when a drug is injected into the blood stream, which results in an immediate effect.
• Phase 3 treatment and allocation is done using a double blind design and randomization, with the treatment/experiment group receiving the drug and the control group receiving a placebo or golden standard drug.
• Phase 3 result analysis measures outcome, including compliance and quality of life.