21 CFR Part 814 - ANSWER -pre market approval of medical devices
45 CFR Part 46 - ANSWER -Federal Research
Studies that investigate the potential undesirable PD effects of a substance on
physiological functions in relation to exposure in the therapeutic range or above -
ANSWER -Safety Pharmacology Studies (Pre-Clinical)
1) To Identify undesirable PD properties of a substance that may have relevance to its
human safety.
,2) To evaluate adverse PD and/or pathophysio effects of a substance observed in
toxicology studies
3)to investigate the mechanism of the adverse PD effects observed and/or suspected -
ANSWER -Drug Development Safety Pharmacology Study Objectives (3)
1) Cardiovascular
2)Respiratory
3)CNS - ANSWER -Three vital organ considered highest priority
1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if needed - ANSWER -Types of Non-Clinical Studies (Animal
Trials)
Study that investigates the mode of action and/or effects of a drug substance in relation
to its desired therapeutic target - ANSWER -Primary Pharmacodynamic Studies
Studies that investigate the mode of action and/or effects of a drug substance not
related to its desire therapeutic target - ANSWER -Secondary Pharmacodynamic
Studies
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities - ANSWER -Core Battery for Cardiovascular
System
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - ANSWER -Core
Battery for Respiratory System
Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature - ANSWER -Core Battery for Central Nervous System
Investigational New Drug Application
FDA - ANSWER -Before clinical trials can be initiated, an application containing the
appropriate information must be submitted to regulatory authorities, in the USA this is
called XXXX and submitted to the XXX (21 CFR Part 312)
, Unapproved drug to be shipped lawfully for the purpose of conducting investigations of
the drug - ANSWER -An IND permits what? (21 CFR Part 312)
Assuring the safety and rights of subjects - ANSWER -FDA's primary objective in all
phases of development is...
Phase II and III - ANSWER -These phase of trials, the FDA helps assure the quality of
the scientific evaluation is adequate to permit evaluation of the drugs safety and efficacy
(21 CFR Part 312)
The FDA - ANSWER -Who determines if Phase II/III studies are likely to yield data
capable of meeting regulatory standards for marketing approval?
1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
4) Phase of development - ANSWER -IND information depends on the amount of
information available, these 4 things are: (21 CFR Part 312)
General Investigational Plan
Protocols for specific human studies - ANSWER -Initial IND should focus on (21 CFR
Part 312)
Build logically on previous submissions
Be supported by additional information such as animal studies and other human studies
- ANSWER -Amendments to IND with new or revised protocols (21 CFR Part 312)
Cover Sheet (FDA Form 1571)
Table of Contents
Introductory statement
investigator's brochure
protocol (s)
Chemistry and manufacturing information
pharm and tox information
previous human experience with investigational drug - ANSWER -A Sponsor Initiated
IND must contain (21 CFR Part 312)
30 Days, unless FDA notifies sponsor of clinical hold
Upon earlier notification, investigations may begin - ANSWER -How long does it take for
an IND to go into effect? (21 CFR Part 312)
1) To facilitate the availability of promising new drugs available to desperately ill patients
as early in the drug development process as possible, before general marketing begins
2)To obtain additional data on the drug's safety and effectiveness - ANSWER -The
purpose of Treatment Use of Investigational Drug (21 CFR Part 312)
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