Chapter 3 Flashcards
Full service pharmaceutical companies are divided into what three categories?
Research & Development - focus on discovering or inventing promising new chemicals or molecules to transform into pharmaceutical products
Manufacturing & Operations - supply chain, manufacturing, trade and distribution (produce and package drug products)
Marketing & Sales - personnel communicate the benefits of the products and create demand for those products (in US, a special Managed Markets group is responsible for outreach to large corporate accounts and managed care organizations)
Approvable letter
Letters sent by FDA to applicant indicating whether the new drug application (NDA) or abbreviated NDA (ANDA) for the product substantially meets the necessary requirements or if changes need to be made
Control or control group
The standard by which experimental observations are evaluated - control group is given either a standard treatment or a placebo
Fast-track drugs
Approval is provided for drugs to meet medical needs for patients with serious or life-threatening conditions
Indication
In terms of drug approval, the exact cause or purpose for which the FDA has approved that a drug can be prescribed
Institutional Review Board (IRB)
A committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and that the rights of the study participants are protected
In US, all clinical trials must be approved by an IRB before they begin.
Off-label
Usage of medication for purposes other than the specific ones appearing in the labeling
Placebo effect
The effect produced by a placebo due to expectations of the patient
Study protocol
The general design and operating features of a clinical trial.
Toxicity
The extent, quality, or degree to which a substance is poisonous or harmful to the body.
Treatment group
A group of patients assigned to receive a specified treatment.
