Study Set Content:
which includes self-inducing sedatives, such as secobarbital, phenobarbital, pentobarbital, barbital, amobarbital and any other drug which contains a salt or a derivative of a salt of barbituric acid; any salt, isomer or salt of an isomer, of amphetamine, such as benzedrine or dexedrine, or any drug which produces a physiological action similar to amphetamine; and hypnotic drugs, such as methaqualone or any other compound producing similar physiological effects
Regulated drug
Regulated drug includes
self-inducing sedatives, such as secobarbital, phenobarbital, pentobarbital, barbital, amobarbital and any other drug which contains a salt or a derivative of a salt of barbituric acid and salt, isomer or salt of an isomer, of amphetamine, such as benzedrine or dexedrine
refers to the scientifically and internationally recognized name of the active ingredients, as approved by the FDA pursuant to R. A. No. 6675, otherwise known as the Generics Act of 1988.
Generic Name
Generics Act of 1988.
R. A. No. 6675
refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors.
Brand Name
Drug Development Process
Discovery and Development 2. Preclinical Research 3. Clinical Research 4. FDA Drug Review 5. FDA Post-Marketing Drug Safety Monitoring
Researchers discover drugs through:
New insights into a disease process to allow researchers to design a product to stop/reverse effects of the disease. • Molecular compounds test to find beneficial effects against any of a large number of diseases. • Unanticipated effects of existing treatments • New technologies-new ways to target medical products to specific sites within the body or to manipulate genetic material.
How it is absorbed, distributed, metabolized and excreted
(Pharmacokinetics
Before a drug is tested in humans, researcher must find out if it has the potential to cause
toxicity.
Two types of preclinical research:
In Vivo
In Vitro
invasive, entry into the body
In Vivo
non-invasive, laboratory
In Vitro:
FDA requires researchers to use
e GLP (Good Laboratory Practices)
Good Laboratory Practices
Study conduct • Personnel • Facilities • Equipment • Written protocols • Operating procedures • Study reports • System of quality assurance oversight for each study to help assure safety of FDAregulated product
IND
(Investigational New Drug
: its purpose is to answer specific research questions related to a medical product
Designing Clinical Trials
investigators spend several months looking at the effects of the medication on about 20 to 80 people who have no underlying health conditions.
Phase I
This phase aims to figure out the highest dose humans can take without serious side effects. Investigators monitor participants very closely to see how their bodies react to the medication during this phase.
Phase I
This involves several hundred participants who are living with the condition that the new medication is meant to treat. They’re usually given the same dose that was found to be safe in the previous phase.
Phase II
Participants: 20-100 healthy volunteers or people with a disease or condition o Length: several months o Purpose: Safety and Dosage o ≈ 70% of medications move to the next phase
Phase I
