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Socra Exam Prep Test 2024- with 100% Correct Answers ( A Graded)
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Socra Exam Prep Test 2024- with 100%Correct Answers ( A Graded)
Safety Pharmacology - 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 - 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 - ANSWER studies in multiple species to select doses for repeated
dose studies; look for AEs/SAEs
repeated dose toxicity - 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 - 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 - ANSWER
requirement 2/4 of regulatory application to dose in humans
regulatory authorities can require more information - 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 - ANSWER requirement 4/4 of regulatory application to dose in humans
,IND - ANSWER permits an unapproved drug to be shipped lawfully for the purpose
of conducting investigations of the drug
21 CFR 312.22 - ANSWER general principles of IND submission
Phases II and III - ANSWER helps assure the quality of the scientific evaluation is adequate
to permit evaluation of the drug's safety and efficacy; determines if studies likely to yield
data capable of meeting regulatory standards for marketing approval
determines how much information is needed about IND - ANSWER novelty of drug, extent drug
has been studied previously, known/suspected risks, phase of development
initial IND - ANSWER general investigational plan and protocols for specific human studies
subsequent amendments for protocols - ANSWER should build logically on previous
submissions and provide additional information such as reports of previous animal and
human studies
(Form FDA 1571) cover sheet - ANSWER requirement 1/5 of sponsor initiated IND
table of contents - ANSWER requirement 2/5 of sponsor initiated IND
introductory statement and general investigational plan - ANSWER requirement 3/5 of sponsor
initiated IND
Investigator's brochure - ANSWER requirement 4/5 of sponsor initiated IND
Protocol(s) - ANSWER requirement 5/5 of sponsor initiated IND
, sponsor initiated IND - ANSWER must contain pharmacology and toxicology information,
previous human experience with investigational drug, and additional information(i.e. drug
dependence and abuse potential, exposure to radiation, plans for pediatric studies)
30 days - ANSWER Maximum length of time for an IND to go into effect after the FDA receives
it (unless the FDA notifies sponsor of clinical hold)
protocol amendments - ANSWER required when a sponsor wants to conduct a study not
already covered by the IND, changes in phase I that significantly affect safety of subjects, any
change in phase II or III that affects safety of subjects, scope of investigation or scientific
quality of study, new investigator added
21 CFR 312.31 - ANSWER IND Information amendment (chemistry/microbiology,
pharmacology/toxicology, clinical)
IND annual review - ANSWER 30 day window
21 CFR 312.300-320 - ANSWER Expanded access to investigational drugs for treatment use
Subpart I to facilitate the availability to patients with serious diseases or conditions when
there is no alternative therapy
expanded access limitations - ANSWER cannot be reported as a well-controlled study for a new
indication; cannot support any other significant change in labeling or advertising of an
approved product
Expanded access protocol submission - ANSWER 1. must be submitted for each type
of expanded accesss
2. can be conducted under existing as an amendment or under a new one
3. expanded access may begin 30 days after submission or sooner upon notification
4. compliance with ICF and IRB regs are still required
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