Socra Exam Prep With 100% Correct And Verified Answers
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Course
Socra
Institution
Socra
Socra Exam Prep With 100% Correct And Verified Answers
Laws - Correct Answer-passed by national legislative bodies; establish authority of national regulatory body
Regulations - Correct Answer-Passed by regulatory authorities; controls how medical products are investigated and approved; have ef...
Socra Exam Prep With 100% Correct
And Verified Answers
Laws - Correct Answer-passed by national legislative bodies; establish
authority of national regulatory body
Regulations - Correct Answer-Passed by regulatory authorities; controls
how medical products are investigated and approved; have effect of law
guidance - Correct Answer-"current thinking" of regulatory bodies; non-
binding
ICH - Correct Answer-Developed to keep people doing things the same
way across the world; international effort to harmonize the technical
requirements for product registration
SOPs - Correct Answer-developed by an organization (sponsor, site, CRO,
IRB)
Compliance with regulations - Correct Answer-goal of SOPs
organization - Correct Answer-SOPs are binding only for this
European Union, Japan, and the US - Correct Answer-The ICH makes
recommendations for adoption by regulatory authorities in:
GCP - Correct Answer-guidelines developed by the ICH for global
implementation on April 30, 1996; developed in consideration of the
current practices of the EU, Japan, US as well as Australia, Canada, the
Nordic countries, and the WHO
GCP Compliance - Correct Answer-an international ethical and scientific
quality standard for designing, conducting, recording and reporting trials
that involve human subjects; provides public assurance that the rights,
safety and well-being of trial subjects are protected and that the clinical
trial data are credible
21 CFR 814 - Correct Answer-Premarket approval for Medical
Devices
45 CFR 46 - Correct Answer-focuses on federal research
21 CFR 50.27 - Correct Answer-documentation of informed consent
Phase I - Correct Answer-bioavailability, pharmacokinetics, safety
Phase II - Correct Answer-small group of subjects with condition of
interest
Phase III - Correct Answer-more experiments, bigger safety profile
Drug Development - Correct Answer-identify potential new
compounds; test appropriate laboratory and animal models to
assess potential activity in humans; screening may involve
thousands of molecules
dosage development - Correct Answer-manufacture pure, stable
drug substance (active ingredient); test various formulations to
optimize the drug product; stability testing in packaging planned to
be used for clinical trials and marketed product
Excipients - Correct Answer-inactive substances used as a carrier
for the active ingredients of a medication
non/pre-clinical activities - Correct Answer-drug discovery and
development of dosage
Safety Pharmacology - Correct Answer-studies that investigate the
potential undesirable pharmacodynamics effects of a substance on
, physiological functions in relation to exposure in therapeutic range
and above
Animal studies - Correct Answer-establish general safety in multiple
species; summarize toxicities observed; determine safety margins
between the planned human dose range and toxic effects on animals;
optimize the dose range, formulation and frequency of
administration
Single dose toxicity - Correct Answer-studies in multiple species to
select doses for repeated dose studies; look for AEs/SAEs
repeated dose toxicity - Correct Answer-studies to assess toxicity
after multiple administrations-results used to
determine doses used for chronic administration;
look for AEs/SAEs
summaries of all acute toxicity studies - Correct
Answer-requirement 1/4 of regulatory application
to dose in humans
28-day studies in one rodent and one non-rodent
species, usually rats and dogs - Correct Answer-
requirement 2/4 of regulatory application to dose
in humans
regulatory authorities can require more
information - Correct Answer-requirement 3/4 of regulatory
application to dose in humans
non-clinical studies have to support the conclusion that the drug can be
administered safely to human subjects - Correct Answer-requirement 4/4
of regulatory application to dose in humans
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