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ICH E11

Clinical Investigation of Medicinal Products in the Pediatric Population

QuestionAnswer
E11R1 was adopted bt the ICH Assembly under ____ on _________. step 4; 18 Aug 2017
It is the goal of this guidance to encourage and facilitate _____ pediatric medicinal product development internationally. timely
The pediatric development program should not _______ of adult studies and availability of a medicinal product for adults. delay completion
It should be noted that the most relevant safety data for pediatric studies ordinarily come from _________ exposure. adult human
There is a need for pediatric formulations that permit accurate dosing and enhance patient compliance such as _______ flavours, colours, liquids, suspensions, chewable tablets, etc.
Since development of pediatric formulations can be difficult and time consuming, it is important to consider the development of these formulations __________. early in product development
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). safety and tolerability
The presence of a ____________ for which the product represents a potentially important advance in therapy suggests the need for relatively urgent and early initiation of pediatric studies. serious or life-threatening disease
A pharmacokinetic/pharmacodynamic approach combined with safety and other relevant studies could avoid the need for ______. clinical efficacy studies
When _______ are being sought for the medicinal product in pediatric patients, or when the __________ of therapy are likely to be different in adults and pediatric patients, clinical efficacy studies in the pediatric population would be needed. novel indications;
Pharmacokinetic studies generally should be performed to support _______ and determine pharmacokinetic parameters in different age groups to support _________. formulation development; dosing recommendations
Measurement of ________ such as pain requires different assessment instruments for patients of different ages. subjective symptoms
Normally the pediatric database is limited at the time of approval. Therefore, ________ is particularly important. postmarketing surveillance
Any classification of the pediatric population into age categories is to some extent ________. arbitrary
What are the possible/example age categorizations given in E11? (5) (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)
Study design issues to be considered with neonates include: (4 things) (1) weight and age, (2) small blood volumes, (3) small numbers of patients at a given centre, (4) difficulties assessing outcomes
By 1 to 2 years of age, _____ of many drugs on a mg/kg basis may exceed adult values. clearance
Factors useful in measuring the effects of a medicinal product on children include skeletal growth, weight gain, _________. school attendance, and school performance
In some cases, it may be appropriate to specifically assess the effect of puberty on a medicinal product by studying ________ pediatric patients. pre- and postpubertal
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 _______. the REB or to be consistent with local legal requirements
Participants of appropriate intellectual maturity should personally sign and date either a separately designed, _______. written assent form or the written informed consent
Emancipated or mature minors (defined by local laws) may be capable of ________. giving autonomous consent
Mechanisms should be in place to ensure that a study can be rapidly terminated should __________ be noted. an unexpected hazard
A fundamental principle in pediatric drug development requires that children should not be enrolled in a clinical study unless necessary to achieve __________. an important pediatric public health need
When obtaining child assent, relevant elements of informed consent should be provided that are ______. appropriate to the child’s capability to understand
It may be necessary to reassess the assent of a child in recognition of their _________ and competency. advancing age, evolving maturity
During clinical studies there is a requirement for obtaining adequate informed consent for continued participation from pediatric participants once a child reaches _______. the age of legal consent
______ regulations related to confidentiality and privacy of pediatric participants must be followed. Local
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. transparency
A _______, not common regional requirements, is at the cornerstone of efficient pediatric drug development and timely delivery of safe and effective medicines for children. common scientific approach
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 _________. the day of birth through the expected date of delivery plus 27 days
In some cases, there are difficulties with generating data across a pediatric population due to a variety of ethical considerations and ________. feasibility issues
Waiting to begin planning until adult development has concluded can ________ to generate meaningful data for pediatric drug development. limit the opportunity
An approach to providing evidence in support a drug/treatment in a pediatric population when it can be assumed that the course of the disease and expected response to a drug would be sufficiently similar in the pediatric and reference population. Pediatric extrapolation
When a drug is studied in a pediatric population, one should consider all factors which may result in different drug responses, such as______ factors that could impact on the extrapolation of data from one population to the other. intrinsic (e.g., developmental) and extrinsic (e.g., geographic)
____ can help quantify available information and assist in defining the design of pediatric clinical studies and/or the dosing strategy. Modelling and Simulation
Well conducted M&S can inform on the pharmacokinetics, pharmacodynamics, ______ and safety of a drug. efficacy
Three key practical factors to consider in pediatric clinical trials are ____________. (1) feasibility, (2) outcome assessments, and (3) long-term clinical aspects, including safety
Pediatric drug development faces unique feasibility issues, including __________. (3 things) (1) small number of eligible children for clinical research, (2) limited pediatric specific resources at research centers, and(3) the scarcity of dedicated pediatric trial networks
Strategies that foster _________ can facilitate participation, recruitment, and acceptability of a clinical study. input from children, their caregivers, and the advocacy communities
A range of quantitative approaches to characterize the interactions between a drug and an organ system which could predict quantitative outcomes of the drug and/or system’s behavior in future experiments. Modelling and simulation
Created by: wickerfurniture