Drugs Flashcards
AE linked to IP-it is called
Adverse Drug reaction (ADR)
Dispensing IP
-The investigator is responsible, but can delegate if the drug is going directly to a subject from pharmacy, it is given to a coordinator to dispense to a subject with directions, given directly to subjects (administered), or given to pharmacy to prepare (IV)
-record drug name, dosage, subject ID, strength, formulation, subject EMR, & sponsor CRF
FDA Bioresearch Monitoring Program (BIMO)
inspections after a new drug application for marketing submitted or if there is evidence of misconduct
FDA Drug Administration
only investigator or sub-I should administrater with the investigator overall responsible
FDA Drug Label Requirements
Study name
Drug name
Subject #
How supplied
Dose per unit
Lot #
Batch #
Federal statement limiting use to experimental studies
FDA: Investigational New Drug
A new drug, antibiotic drug, or biological drug that is used in a clinical investigation, also includes a biological product that is used in vitro for diagnostic purposes
ICH Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use
ICH: Investigational Product (drug)
FDA: Investigational New Drug (IND)
ICH: pharmaceutical form of active ingredient or placebo being tested or used in a clinical trial including with marketing authorization when used or assembled differently from approved form, unapproved indication, or to gain info about an approved use
FDA: New, antibiotic, or biological drug used in a clinical investigation, biological (in vitro for diagnostic)
IND Exemptions (21 CRF 321.2(b)) for marketed drug or biologic (ALL SIX must be met)
- Not intended to be reported to FDA in support of new indication or other significant labeling change
- Not intended to support significant change in advertising
- Doesn’t involve route of administration or dosage level, use in a subject population, or other factor that significantly increases risk (or decreases acceptability of risk) associated
- Conducted in compliance of IRB/IEC review and informed consent
- Conducted in compliance of promotion & sale of drug requirements
- Doesn’t intend to evoke exception from informed consent for emergency research (21 CFR 50.24)
Proposed Package Insert
labeling for a drug, from the FDA based on info in the application, summarizes what FDA has determined to be a safe & effective use of the product
What does 21 CFR 312 cover?
Investigational New Drugs
