The study of medicines (Pharmakon)that includes: indication, administration, transport
around the body, responses produced
Pharmacotherapeutics
Administration of drugs for the purpose of disease prevention or treatment and relief of
suffering.
Physiology
Normal function of the body
Pathophysiology
Abnormal changes caused by (or resulting in) disease
Pharmacodynamics
What a drug does to the body
Pharmacokinetics
What the body does to the drug
Drug
chemical agent capable of producing biologic responses within the body
Therapeutic effect
Desirable response
Adverse effect
Undesirable response
Biologics
Agents naturally produced in Aminal cells, used to treat and prevent various illnesses
Natural health products (NHP)
,Naturally occurring health substances use to maintain or restore health
Drug Regulation
Health Products and Food Branch (HPFB) of Health Canada has a mandate to "maximize
the safety provided by the regulatory system for health products and food"
Canadian federal law demands that the manufacturer of a drug demonstrate that it is
safe as well as effective for a particular purpose. Laws and regulations of drugs safe
and effective Step 1 in the approval process of drugs Preliminary research on drugs is
done Step 2 in the approval process of drugs Preclinical studies in cultured cells, living
tissues, and animal species Step 3 Phase I
safety phase: small group of healthy humans
Step 3 Phase II
The effective phase: small group of humans with the target disorder
Step 3 Phase III
The confirmation phase: larger groups of patients with the target disorder. Double blind
study. Only 10% make it to phase III
Step 3 Phase IV
Ongoing research
Step 4 for approval of drugs
The pharmaceutical company completes a New Drug Submission to Health Canada. This
report outlines significant safety and effectiveness information including testing data on
how the drug product will be manufactured and packaged, expected therapeutic
benefits, and adverse reactions.
Step 5 for approval of drugs
A committee of drug experts comprises medical and drugs scientists, reviews the NDS
to identify protection, drug benefits, and risks.
Step 6 for approval of drugs
Health Canada reviews the information relating to the drug product and releases crucial
information to health professionals and consumers.
Step 7 for approval of the drugs
Health Canada gives Notice of Compliance, NOC, and Drug Identification Number, DIN.
Both are required by the manufacturer for marketing the drug product.
Step 8 for the approval of the drugs
, Health Canada also monitors the effectiveness of the drug and any safety concerns
once it reaches the market. This is accomplished through routine inspection, notices,
newsletters, and consumer and health care provider feedback.
Pricing and Access to Prescription
The role of Patented Medicine Prices Review Board independent of Health Canada is to
make sure that prices by manufactures for patented medicines do not become
excessive.
drug that is medically therapeutic is commonly referred
Drug regulations requires that a drug be what for a specific purpose?
safe and effective
Drug indication
intended or indicated uses for any drug
Mechanism of Action
how a drug produces its physiological effect in the body
2 drugs having the same effect, but at different doses, which one is more effective?
ideal drug produces a rapid, predictable response at a relatively low doses
Therapeutic classification of a drug
Organises drugs according to therapeutic usefulness in the treatment of a disease.
Pharmacological classification of a drug
Describes how drug acts at molecular, tissue and body system level
Chemical drug names
Drugs named for chemical composition or by IUPAC naming
Generic drug name
Assigned International Non-proprietary name. ONE generic name per drug
Brand/Trade drug name
Name chosen by the company manufacturing it. Many trade names for each generic
drug.
Bio-avaialability
the quantity of drug absorbed into the systemic circulation and available to reach target
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Stetson. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $9.99. You're not tied to anything after your purchase.