BME 214 Week 3 Part 2 Test
With Solution
Product Development in Health Care Delivery - ANSWER The ultimate goal
for medical device, drug, biologic or their combination development is to get
the medical product
... once proven safe and effective ...
to market
as quickly as possible
How Does One Determine if
It is Safe and Does It Work? - ANSWER By Use of Best Practices
to
Evaluate the Safety and Efficacy
of
Drugs, Biologics & Devices
(and combinations thereof)
Product Development in Health Care Delivery - ANSWER In the US, in order
to answer this means implementing an in-depth product testing and
evaluation process that involves nonclinical laboratory studies,
as well as,
,clinical studies
... otherwise known as ...
Preclinical & Clinical Trials
Pre-Clinical Trials and Clinical Trials - ANSWER are the processes by which
scientists, engineers and practitioners design and implement 'tests' to
verify and validate
drugs, biologics, medical devices, as well as, their combinations to see if
they are
SAFE and EFFECTIVE
Preclinical Trials - ANSWER Preclinical trials, also named preclinical studies
and nonclinical studies, is a stage of research and development (R&D) that
begins before clinical trials (testing in humans) can begin, and during which
important feasibility, iterative testing and safety data are collected for drugs,
devices and biologics or their 'combinations'.
Products may include new medical devices (diagnostic tools and therapeutic),
drugs, biologics, such as, gene therapy solutions or their combinations
The main goals of pre-clinical studies are to determine (for drugs) the safe
dose for first-in-man study and (for medical devices) assess a product's
safety profile.
, Nonclinical Laboratory Study - ANSWER A non-clinical laboratory study* is an
in vivo or in vitro test /experiment in which a test article is studied
prospectively in a test system under laboratory conditions to determine its
safety (21 CFR 58.3(d)).
Requires implementation of good laboratory practice (GLP)
A test article - ANSWER may be a medical device for human use, or other
article subject to regulation under the Federal Food, Drug, and Cosmetic Act
(the Act) or under sections 351 and 354-360F of the Public Health Service Act
(21 CFR 58.3(b)), e.g., drug, biologic, or their combinations and cosmetic.
A test system - ANSWER is any animal, plant, microorganism, or subparts
thereof to which the test or control article is administered or added for study.
A test system also includes appropriate groups or components of the system
not treated with the test or control articles (21 CFR 58.3i)).
Note: bench tests - ANSWER such as chemical or physical testing, and any
other studies that do not involve use of an animal, plant, or microorganism,
are not included under non-clinical laboratory studies but are utilized for
different but related purposes.
With Solution
Product Development in Health Care Delivery - ANSWER The ultimate goal
for medical device, drug, biologic or their combination development is to get
the medical product
... once proven safe and effective ...
to market
as quickly as possible
How Does One Determine if
It is Safe and Does It Work? - ANSWER By Use of Best Practices
to
Evaluate the Safety and Efficacy
of
Drugs, Biologics & Devices
(and combinations thereof)
Product Development in Health Care Delivery - ANSWER In the US, in order
to answer this means implementing an in-depth product testing and
evaluation process that involves nonclinical laboratory studies,
as well as,
,clinical studies
... otherwise known as ...
Preclinical & Clinical Trials
Pre-Clinical Trials and Clinical Trials - ANSWER are the processes by which
scientists, engineers and practitioners design and implement 'tests' to
verify and validate
drugs, biologics, medical devices, as well as, their combinations to see if
they are
SAFE and EFFECTIVE
Preclinical Trials - ANSWER Preclinical trials, also named preclinical studies
and nonclinical studies, is a stage of research and development (R&D) that
begins before clinical trials (testing in humans) can begin, and during which
important feasibility, iterative testing and safety data are collected for drugs,
devices and biologics or their 'combinations'.
Products may include new medical devices (diagnostic tools and therapeutic),
drugs, biologics, such as, gene therapy solutions or their combinations
The main goals of pre-clinical studies are to determine (for drugs) the safe
dose for first-in-man study and (for medical devices) assess a product's
safety profile.
, Nonclinical Laboratory Study - ANSWER A non-clinical laboratory study* is an
in vivo or in vitro test /experiment in which a test article is studied
prospectively in a test system under laboratory conditions to determine its
safety (21 CFR 58.3(d)).
Requires implementation of good laboratory practice (GLP)
A test article - ANSWER may be a medical device for human use, or other
article subject to regulation under the Federal Food, Drug, and Cosmetic Act
(the Act) or under sections 351 and 354-360F of the Public Health Service Act
(21 CFR 58.3(b)), e.g., drug, biologic, or their combinations and cosmetic.
A test system - ANSWER is any animal, plant, microorganism, or subparts
thereof to which the test or control article is administered or added for study.
A test system also includes appropriate groups or components of the system
not treated with the test or control articles (21 CFR 58.3i)).
Note: bench tests - ANSWER such as chemical or physical testing, and any
other studies that do not involve use of an animal, plant, or microorganism,
are not included under non-clinical laboratory studies but are utilized for
different but related purposes.
