Analytical Testing
This is a critical step in drug product formulation and release
Analytical Testing
What is the name of the apparatus that is used to prove proof of concept during research and prior to scale up ?
Bench top
Phase I
NOC and DIN are issued at what phase of the new product launch lifecycle
SUR
Submission Under Review
These samples are tested for degradation of a product during the lifecycle
Stability
Commonly used equipment in Upstream bioprocessing
Bioreactor or Fermentor
Phase II development assesses the long term ______ under various conditions to impact the shelf-life and expiry
Stability
Health Canada, in collaboration with the Public Health Agency of Canada, also monitors biologic adverse events, investigates complaints and problem reports, maintains post approval surveillance, and manages recalls, as required at this stage
Post launch
In the United States under the Food and Drug Act for the temporary approval of a not-fully-released drug product for a specific use
Emergency Drug Use Authorization
Which document contains all of the testing information that a product must meet prior to release ?
involves scaling up the output of a process
Upstream Processing
Once received by Health Canada it becomes a Submission Under Review or SUR until which time sufficient data regarding potency, safety and efficacy can be gathered
NDS (New Drug Submission)
a harmless pill or medicine, when used in clinical trials, the placebo will look identical to the regular medication, however it will not contain any active ingredient.
Placebo
These trials test an experimental drug on a small group of people for the first time.
Phase I
Testing methods must be
Validated
This type of histochemistry involves the process of selectively identifying antigens (proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues
Immunohystochemistry
Review of preclinical and clinical trial results, determine that benefits outweigh risks to patient are what stage of the New Product Launch Lifecycle?
Market Approval
In what type of blind trial does only the investigator or the person collecting data and performing the study know which group is being given the drug product and which is receiving the placebo
Single Blind Trial
The drug is given to even larger groups of people (usually 1,000 or more)
All excipients, active ingredients and components in the drug product must undergo ______ testing into production.
release
This type of Histochemistry is used to determine cell population health and percentage of cell death during research phases of new drug development
Flow Cytometry
Pre-clinical studies, Clinical trials, Regulatory product submission, submission review, market authorization decision area all part of what stage of the new product launch life cycle
Pre-Market Stage
A phenomena when a patient wants to feel better, they take the medication and perceive that they feel better
Placebo Effect
•figure out the best dose - Phase?
Phase II