Clinical Investigation of Medicinal Products in the Pediatric Population
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| E11R1 was adopted bt the ICH Assembly under ____ on _________. | show 🗑
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| show | timely
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| The pediatric development program should not _______ of adult studies and availability of a medicinal product for adults. | show 🗑
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| It should be noted that the most relevant safety data for pediatric studies ordinarily come from _________ exposure. | show 🗑
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| show | flavours, colours, liquids, suspensions, chewable tablets, etc.
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| show | early in product development
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| For products exclusively used in pediatric populations, the entire development program will be conducted in the pediatric population except for initial _________ data (usually obtained from adults). | show 🗑
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| show | serious or life-threatening disease
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| show | clinical efficacy studies
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| show | novel indications;
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| show | formulation development; dosing recommendations
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| Measurement of ________ such as pain requires different assessment instruments for patients of different ages. | show 🗑
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| Normally the pediatric database is limited at the time of approval. Therefore, ________ is particularly important. | show 🗑
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| show | arbitrary
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| show | (1) Preterm newborns, (2) term newborns (0-27 days), (3) infants and toddlers (28 days to 23 months), (4) children (2-11 years), (5) adolescents (12-16/18 years dependent on region)
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| Study design issues to be considered with neonates include: (4 things) | show 🗑
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| show | clearance
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| Factors useful in measuring the effects of a medicinal product on children include skeletal growth, weight gain, _________. | show 🗑
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| show | pre- and postpubertal
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| As a rule, a pediatric subject is legally unable to provide informed consent. Where appropriate, participants should assent to enroll in a study. Age of assent is to be determined by _______. | show 🗑
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| Participants of appropriate intellectual maturity should personally sign and date either a separately designed, _______. | show 🗑
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| Emancipated or mature minors (defined by local laws) may be capable of ________. | show 🗑
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| show | an unexpected hazard
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| show | an important pediatric public health need
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| show | appropriate to the child’s capability to understand
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| It may be necessary to reassess the assent of a child in recognition of their _________ and competency. | show 🗑
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| During clinical studies there is a requirement for obtaining adequate informed consent for continued participation from pediatric participants once a child reaches _______. | show 🗑
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| ______ regulations related to confidentiality and privacy of pediatric participants must be followed. | show 🗑
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| The _______ of clinical research in pediatric drug development includes the registration of clinical trials on publicly accessible and recognized databases, and the public availability of clinical trial results. | show 🗑
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| show | common scientific approach
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| The neonatal period for term and post-term newborn infants is defined as the day of birth plus 27 days. The neonatal period for preterm newborn infants is defined as _________. | show 🗑
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| show | feasibility issues
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| show | limit the opportunity
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| show | Pediatric extrapolation
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| show | intrinsic (e.g., developmental) and extrinsic (e.g., geographic)
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| ____ can help quantify available information and assist in defining the design of pediatric clinical studies and/or the dosing strategy. | show 🗑
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| show | efficacy
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| Three key practical factors to consider in pediatric clinical trials are ____________. | show 🗑
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| Pediatric drug development faces unique feasibility issues, including __________. (3 things) | show 🗑
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| Strategies that foster _________ can facilitate participation, recruitment, and acceptability of a clinical study. | show 🗑
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| show | Modelling and simulation
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