Prior to clinical trials, the sponsor or applicant must assemble data which demonstrates to the FDA that the compound would be reasonably safe for human use in clinical trials.
This can be done through animal testing or clinical human trials where the drug was already approved (other countries).
In the New Drug Application process (NDA), what is Phase I?
involve a very small number of healthy volunteers and is used to determine the maximum tolerated dose of the applicant drug
What is Phase II?
Phase II trials are primarily concerned with the effectiveness of the drug.
This phase uses volunteers from the intended disease group.
Usually several hundred individuals are involved.
What is Phase III?
Phase III trials are the last trials before the NDA would be submitted to the FDA.
Phase III trials may put the applicant drug against another drug in a "head to head" contest to determine relative effectiveness against a known entity.
What is Phase IV?
Phase IV takes place AFTER the NDA has been approved and the drug is marketed in the general population. It is a follow up procedure to gain knowledge of any resulting problems after the release of the medication.
What is the Investigational New Drug Review?
it is an application for exemption to the Federal Law which prohibits interstate shipment of unapproved drug products.
What are the two names given to drugs?
Chemical and Generic
What does the chemical name tell a pharmacist?
How it can be synthesized
What is a chemical name?
a chemical name is a written description of the chemical structure of a drug. It tells what is in it, and where it is attached
What is a generic name?
The generic name is the one under which the drug's NDA was approved.
It is assigned by the manufacturer, and approved by the FDA.
What is the trade name?
The trade name is applied by the manufacturer of the drug to provide a brand loyalty.
What is the National Drug Code (NDC) number?
The National Drug Code (NDC) of a drug is a unique number which identifies a drugs manufacturer, drug name, strength, dosages form, and package size.
It is a series of 3 sets of numbers.
What do the numbers on the NDC represent?
The first set of numbers indicates the drug's manufacturers
The second set of numbers indicate the specific drug entity
The third set of numbers indicate the package size