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|a YDX
|b eng
|e rda
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|d OPELS
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|a 9780323904292
|q electronic book
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|q electronic book
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|z 9780323884594
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|a (OCoLC)1449908817
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|a 615.1083
|2 23/eng/20240807
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| 049 |
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|a TXAM
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| 245 |
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|a Essentials of translational pediatric drug development :
|b from past needs to future opportunities /
|c edited by Elke Gasthuys, Karel Allegaert, Lien Dossche, Mark Turner.
|
| 264 |
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1 |
|a London, United Kingdom ;
|a San Diego, CA, United States ;
|a Cambridge, MA, United States :
|b Elsevier, Academic Press, an Imprint of Elsevier,
|c [2024]
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| 264 |
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4 |
|c ©2024
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| 300 |
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|a 1 online resource :
|b illustrations (some color)
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| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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|a online resource
|b cr
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| 347 |
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|a text file
|2 rdaft
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| 504 |
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|a Includes bibliographical references and index.
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| 588 |
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|a Online resource; title from PDF title page (ScienceDirect, viewed August 7, 2024).
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| 505 |
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|a Front Cover -- ESSENTIALS OF TRANSLATIONAL PEDIATRIC DRUG DEVELOPMENT -- ESSENTIALS OF TRANSLATIONAL PEDIATRIC DRUG DEVELOPMENT: FROM PAST NEEDS TO FUTURE OPPORTUNITIES -- Copyright -- Contents -- Contributors -- I -- From past to current needs in pediatric drug research -- 1 -- Preface: Overview of pediatric drug development and pharmacovigilance -- Introduction -- Elements of drug development -- Approaches to drug development -- Clinical pediatric drug development -- Foundational research -- Goals of drug development -- Pharmacovigilance -- Pharmacovigilance tailored to children -- Doing studies -- The importance of collaboration -- Not in scope -- References -- 2 -- Historical perspective -- Labeling of medicines -- Therapeutic orphans -- Pediatric medicines initiatives -- Worldwide initiatives to stimulate pediatric clinical trials -- The US legislation -- The European Pediatric Regulation -- "Better Medicines for Children" resolution of the World Health Assembly -- Pediatric medicines initiatives in other countries across the globe -- ICH E11: Harmonizing the development of pediatric medicines -- Pediatric medicine networks -- Pediatric clinical pharmacology -- References -- 3 -- Parents' and children's needs in the drug development process -- Introduction: Unmet needs for pediatric patients -- Pediatric drug development -- What are the benefits of pediatric and clinical trial regulations? -- Pediatric regulation in the United States (US) and in the European Union (EU) -- Novel EU clinical trial regulation -- Research -- Agenda setting and translational research -- Pediatric patient-centered clinical trials -- Clinical trials at home -- Clinical trial awareness and communication -- Consent for clinical research -- Data sharing -- Registries and data platforms.
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| 505 |
8 |
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|a The specific parents/children's needs for accessing early diagnosis/screening programs, innovative treatments, clinical tri ... -- Early diagnosis -- Innovative treatments -- Access to cross-border clinical trials -- Compassionate use (early access) programs -- The specific parents/children's needs for empowerment and training to be active actors in research and for their health -- Empowerment and training -- The role of patient organizations -- Involvement of children/young patients -- Pediatric networks -- Authors' final reflections -- References -- Further reading -- 4 -- The needs from the regulatory authorities' perspective-current status and worldwide initiatives -- Introduction -- Definitions -- The regulatory requirements for the drug submission process -- Acts, laws, and guidance -- Acts/laws -- Data -- Data requirements -- Data scope -- Preclinical or nonclinical -- Clinical -- Instructions for the use of a therapeutic -- Burden of proof -- How regulators work? -- Regulators' profile -- Communication -- Between regulatory agencies -- With other stakeholders -- Follow-up file submission -- Decision-making -- Post-marketing -- Has the regulatory approach changed over the years and what will the future bring? -- Concluding thoughts -- References -- Further reading -- Additional interesting references -- 5 -- Optimal pediatric drug development- the partnership between patients/parents, academia, regulatory authorities ... -- Pharmaceutical industry's participation in pediatric drug development -- Pharmaceutical industry involvement in all phases of pediatric drug development -- Drug discovery -- Preclinical research -- Development of pediatric formulations -- Clinical research -- Postmarketing monitoring -- Partnership between the pharmaceutical industry and other stakeholders within pediatric drug research -- Patients/parents.
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| 505 |
8 |
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|a Academia/clinicians in clinical practice and research -- Regulatory authorities -- Co-operation among pharmaceutical companies -- Organization of pharmaceutical industry pediatric drug research -- The future of pharmaceutical industry pediatric drug research -- References -- 6 -- The needs, challenges, and opportunities from the academic researchers' perspective -- Academia participate in translational pediatric drug research -- Roles of academia within pediatric drug research -- Drug discovery and development -- Preclinical research -- Clinical research -- Postmarketing pharmacovigilance -- Repurposing -- Interplay between academia and other stakeholders within pediatric drug research -- Pharmaceutical industry -- Governmental authorities -- Healthcare professionals -- Involvement of patients and parents in the clinical research process -- Organization of academic pediatric drug research -- Role of the academic institutions: Education, training, and facilities -- Education/training -- Facilities -- Academic expertise core facilities -- Academic clinical trial units -- Academic technology transfer offices -- Funding -- Open science -- Impact -- Initiatives examples -- Conclusions: The future for academia participating in pediatric drug research -- References -- 7 -- The health care provider's needs in the pediatric drug development process -- Introduction and background of prescribing medicines for children -- Introduction -- Historical aspects and background -- Current daily clinical practice: Challenges and (practical) approaches -- The current clinical situation: Global extent of off-label and unlicensed medicines use in children -- Off-label use -- Unlicensed medicine use -- Insufficient access to on-label medicines -- Practical approaches to current prescribing challenges -- Off-label medicines -- When to prescribe off-label medicines?.
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| 505 |
8 |
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|a Challenges when prescribing off-label medicines -- How to prescribe off-label medicines? -- Use of pediatric medicine formularies -- Benefit-risk assessment off-label medicine use in children -- Informed consent -- Unlicensed medicines -- Challenges when prescribing unlicensed medicines -- Possible approaches when prescribing unlicensed medicines -- Pediatric medicine development as a possible solution -- health care providers in collaboration with other stakeholders -- Future perspectives: Needs and priorities -- References -- II -- Designing pediatric drug research: From bench to bedside and back -- 8 -- Application of in vitro models for pediatric translational research -- Introduction -- Methods -- In vitro models for protein activity measurements -- Types of in vitro models in translational pediatric research -- Experimental conditions for activity assays with in vitro pediatric models -- Data sets generated with in vitro pediatric or juvenile ADME models -- In vitro studies with tissues derived from pediatric donors -- In vitro studies with tissues derived from neonatal or juvenile animals -- Translation of in vitro ADME activity data by IVIVE approaches -- ADME protein abundance measurements on pediatric tissues -- Positioning of protein content analysis in translational pediatric research -- Technological state-of-the-art of quantitative proteomics -- Application of quantitative proteomics to reveal ontogeny of DMEs and transport proteins -- Application of proteomics data in relation to in vitro ADME tools -- Discussion -- References -- 9 -- Application of preclinical juvenile animal models -- Introduction -- Regulatory perspective -- Pediatric Investigation Plan and Pediatric Study Plan -- Designing the nonclinical strategy -- Need for a juvenile animal toxicity study -- Timing of juvenile animal toxicity studies.
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| 505 |
8 |
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|a Animal species and age categories to be considered -- Mice -- Rat -- Rabbit -- Dog -- Sheep -- Pig -- Nonhuman primates -- Age of the animals -- Study design -- Study end-points -- Route of administration -- Dose selection -- Formulation and excipients -- ADME -- Reproducibility and translatability of animal research -- The reproducibility crisis: the standardization fallacy -- The translatability crisis: animal models -- Conclusions -- References -- 10 -- Application of pediatric-adapted modeling and simulation approaches -- Quantitative pharmacology in pediatric drug development -- Basic PK/PD concepts of small and large molecules -- Exposure-response relationships -- Overview of the available toolbox -- Allometric approaches -- Selecting an allometric exponent -- When is allometric scaling appropriate? -- Allometric scaling from preclinical animal species -- Allometric scaling of monoclonal antibodies -- Physiologically based pharmacokinetic modeling -- Core principles of PBPK modeling -- Building a pediatric-PBPK model -- Step 1: Gather drug-dependent data to define a drug model -- Step 2: Learn and confirm in an adult population -- Step 3: Verify and apply the PBPK model in children -- Pediatric PBPK model applications -- Dose selection and study design -- Drug-drug interactions -- Special pediatric populations and disease effects -- Protein drugs -- Pharmacodynamics and toxicology -- Population pharmacokinetics -- PopPK modeling and simulation -- Integration with allometric scaling and ontogeny -- Linking PK with PD -- Moving pediatric adapted modeling and simulation approaches toward maturity -- Rational selection and application of available modeling and simulation tools -- The pediatric diseased populations -- Pediatric and developmental pharmacodynamics -- Conclusion -- References.
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| 505 |
8 |
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|a 11 -- The promise of omics approaches for pediatric drug development.
|
| 520 |
|
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|a Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development.
|
| 650 |
|
0 |
|a Pediatric pharmacology.
|
| 650 |
|
0 |
|a Drug development.
|
| 650 |
|
0 |
|a Drugs
|x Design.
|
| 650 |
|
2 |
|a Drug Design
|
| 650 |
|
6 |
|a Pharmacologie pédiatrique.
|
| 650 |
|
6 |
|a Médicaments
|x Développement.
|
| 650 |
|
6 |
|a Médicaments
|x Conception.
|
| 655 |
|
7 |
|a Electronic books.
|2 local
|
| 700 |
1 |
|
|a Gasthuys, Elke,
|e editor.
|
| 700 |
1 |
|
|a Allegaert, Karel,
|e editor.
|
| 700 |
1 |
|
|a Dossche, Lien,
|e editor.
|
| 700 |
1 |
|
|a Turner, Mark
|c (Neonatologist),
|e editor.
|1 https://id.oclc.org/worldcat/entity/E39PCjHdhpwYWG4hq68TCQb7h3
|
| 710 |
2 |
|
|a ScienceDirect (Online service)
|
| 776 |
0 |
8 |
|i Print version:
|t Essentials of translational pediatric drug development.
|d London : Academic Press, [2024]
|z 9780323884594
|
| 856 |
4 |
0 |
|u http://proxy.library.tamu.edu/login?url=https://www.sciencedirect.com/science/book/9780323884594
|z Connect to the full text of this electronic book
|t 0
|
| 955 |
|
|
|a Elsevier ScienceDirect 2026-2027
|
| 994 |
|
|
|a 92
|b TXA
|
| 999 |
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|s 07d0d47c-f44e-4a89-a3ff-d72c53a45c18
|t 0
|
| 952 |
f |
f |
|a Texas A&M University
|b College Station
|c Electronic Resources
|s www_evans
|d Available Online
|t 0
|e RJ560 .E77 2024
|h Library of Congress classification
|
| 998 |
f |
f |
|a RJ560 .E77 2024
|t 0
|l Available Online
|