Drug Discovery and Development Process

A collection of vocabulary flashcards based on the Drug Discovery and Development Process lecture.

Drug Discovery

screen for the effect

Preclinical Studies

3-6 years

proof of mechanism

• how it works

• does what you claim

• minimal study

• dosing limits

Phase I Trials

• safety

• does it work in humans

• establish dosing range

Phase II Trials

• safety

• efficacy

• dose selection

Follow-up studies to evaluate effectiveness, further assess safety, and determine the optimal dose for further testing.

Phase III Trials

• safety

• efficacy

Large-scale trials to confirm the effectiveness of the drug, monitor side effects, and compare it to commonly used treatments.

comparrison between different demographics (race, age location)

Phase IV Trials

Studies done after the drug has been approved to gather more information on the drug's safety and long-term effectiveness.

NDA (New Drug Application)

Formal proposal to the FDA for approval to market a new drug after it has completed clinical trials. first application with human data

who approves a new drug

health product and food administration (HPFB) in Canada

post marketing activities

1 new drug is approved

health canada

canadian food inspection agency

CADTH (Canadian Agency for Drugs and Technologies in Health)

Organization that provides evidence-based information on the effectiveness and cost-effectiveness of drugs to inform healthcare decision-making.

Pharmacovigilance

The science related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Post-marketing Surveillance

Monitoring of drugs after they have been released into the market to identify any long-term effects.

Priority Review (PR)

Applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases.

Notice of Compliance with Conditions (NOC/c)

Applies to drugs with promising evidence of clinical effectiveness throughout the clinical trial phases. Approval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s benefit and safety, quality and marketing

what are the regulatory bodies reviewing?

safety, effectiveness and quality of the product.

Major regulatory bodies

what factors influence the accelerated review process from health canada

For health conditions that are serious, life-threatening or for a severely debilitating disease (such as Alzheimer’s disease, cancer, AIDS, or Parkinson’s Disease), the HPFB can provide faster authorization of a drug

stage 1 “pre-discovery“

stages 2 and 3 - drug discovery & preclinical studies

stage 4 - clinical trials

stage 5 - review & approval + stage IV

project ORBIS

an initiative that aims to improve the efficiency of clinical trials by streamlining the regulatory process and utilizing real-world evidence across multiple countries.

Madical device regulations

are regulated by Health Canada

part 1 - Medical devices other than in vitro diagnostic devices

part 2 - in vitro diagnostic devices

clinical trial phases

preclinical - phase 1 - phase 2 - phase 3 - phase 4

phase 1

the safety phase - placebos are administered

phase 2

the effectiveness phase - drug is given to a larger group of individuals

phase 3

the confirmation phase - if results from phase 2 look promising, then the drug is given to an even larger group of individuals

phase 4

the monitoring phase - after the drug is already approved and being sold. more information is gathered on the best ways to utilize the drugand monitor long-term effects.

what If the drug is to be used outside the terms of the market approval?

to make a new claim, the produce will have to go through the whole process again. a CTA will need to be submitted to health Canada in order to obtain a NO Objection Letter.

what phase of brug development cost the most

Drug discovery & preclinical