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• W2893289265 abstract "A health care provider's focus when instituting drug therapy to treat a patient is to design and implement the optimal therapeutic regimen for an individual patient. Determining optimal pharmacotherapy requires the health care provider to have a comprehensive understanding of disease-specific pathophysiology combined with a comprehensive understanding of the effects of age, disease, and pharmacogenetic makeup on a drug's pharmacokinetic (PK) and pharmacodynamic (PD) characteristics. Only with the integration of these factors can one attempt to define an optimal pharmacotherapeutic regimen for an individual patient; clearly, the continuum of age in the pediatric patient adds further complexity to these processes. This supplement comprises 13 papers written by internationally recognized experts in their respective fields who address contemporary challenges confronted by pediatric practitioners when defining optimal pharmacotherapy. The first paper,1 written by us and two distinguished colleagues, addresses the dynamic maturational changes that occur following birth through adolescence. Age and size are two very important clinical predictors of drug disposition and effect as both change dramatically as the child develops and grows. Only after integrating a patient's severity of illness(es), age, size, and pharmacogenetic makeup with a drug's PK and PD characteristics can one attempt to implement the best pharmacotherapeutic regimen.1, 2 However, without age-appropriate drug formulations, drug therapy is severely hampered. To this point, Thabet and colleagues3 comprehensively summarize the current state of drug formulations, with an emphasis on the many new, exciting drug formulation strategies moving away from “simple” traditional liquids to novel formulations including solid dosage forms, easy to administer across the age continuum, stable under a range of storage conditions, and utilizing matrices that are safe and cost effective. Safety is of paramount importance in the development of clinically useful, broad-platformed drug formulations when administered to patients of all ages and specifically to the pediatric patient. Rieder4 expertly reviews the classification, risk factors, burden, and ontogenic influences on adverse drug reactions in children and offers a thoughtful, methodical approach, the “five A's,” to consider when assessing the possibility/probability of an adverse event within the context of drug therapy. The nature of adverse drug reactions changes as the child grows and may manifest differently than in adults. Only with continuous suspicion by practitioners of the possibility of an adverse drug reaction arising in their patients can the problem be best characterized, addressed, and effectively managed. The many components that influence drug administration, disposition, effect, and adverse effect across the pediatric age range are key to an understanding of drug therapy in pediatrics. Although long labeled as “therapeutic orphans,” great strides have been made over the past two decades in understanding these many components and how to design and execute clinical trials in the pediatric age group. Clinical trials in target pediatric patients with targeted disease(s) are fundamental to a better understanding of age-size influenced disposition characteristics and the definition of optimal age-appropriate drug doses in children.5 Four detailed, expert reviews6-9 address the current status of drug development in children and the incorporation of innovative study designs available to best capture the most from limited data sets. The data derived from clinical trials integrated with modern modeling and simulation methodologies enhances the accuracy of dose projections for a patient population as well as the individual patient. With the broad acceptance, utilization, and continuously improving detail and accuracy of patient data being incorporated into the electronic medical record, the value of mining “big data sets” cannot be overstated, providing a broad view of drug use, response, and safety in the real-world setting. Each of these four articles6-9 provides insight and substance to the importance of data-informed modeling and simulation-guided clinical trial design; study execution; data-driven modification, if necessary; successful trial conclusion; and proper analysis with relevant, accurate interpretation. Pediatric health care providers are best served when the results from a comprehensive, multifaceted, thoughtful, methodical clinical drug development program is included in the sanctioned official product labeling for all to use in their pharmacotherapeutic decision tree. One major contemporary challenge to this entire process is the increasing scourge of obesity worldwide and woven throughout the pediatric age continuum. Ameer and Weintraub10 very nicely review the epidemiology, pathogenesis, and clinical relevance of obesity as well as the many answers and remaining questions regarding effective obesity treatments and drug dosing across the age-weight obesity spectrum.11 Though many reviews have been published on dosing strategies of select drugs in obese to morbidly obese pediatric patients,12 important questions remain as to the ideal weight parameter (eg, total, ideal, fat-free body weight) to use in defining an optimal dose. Some have attempted to utilize a drug group's known physicochemical characteristics to improve dose projections in obese patients with limited success, underscoring that no one approach is ideal for all drugs. Overall, as meticulously addressed in this paper, the projected morbidity of this scourge cannot be overemphasized. The next four papers of this supplement address important clinical challenges and updates in the care of infants and children. Le and Bradley13 expertly address contemporary antibiotic drug therapy with a focus on important, commonly used antibiotics and the clinical relevance and impact of the integrated PK-PD profile to antibiotic efficacy. The authors address current challenges and offer potential, thoughtful solutions for consideration in future development programs. As multiple papers in this supplement have noted, vaccines have had a tremendous, positive impact on pediatric health worldwide. Ndaya-Oloo and colleagues14 expertly review the state of individual vaccines, their importance, new constructs, and new technologies while addressing emerging strategies and programmatic challenges surrounding vaccine use and development today. These authors also address the important area of vaccination during pregnancy with harmonized safety monitoring, and then conclude with a focus on the unfortunate and important aspects of vaccine shortages, offering practical coping strategies to this ever-increasing problem. An area gaining increasing focus and scrutiny involves the use of sedatives and analgesics, or so-called analgosedatives, and their possible long-term negative neurodevelopmental effects in neonates and young infants.15 Schiller and colleagues16 comprehensively review the important analgosedatives commonly used in children, with a focus on critically ill infants, doses used, durations employed, combinations of agents, and the emerging evidence of their possible negative effects on the brain and cognition.17 Schiller et al16 lay out a foundation for possible molecular mechanism(s) and identify at-risk patients and the need for intense research, but above all remind pediatric practitioners of our important responsibility to always and continuously assess and monitor patients for the possible negative effects of our therapeutic intervention(s) on the multifaceted developmental changes occurring as the infant grows to adulthood. The importance of breastfeeding for at least the first six months of an infant's life is well established. So, too, are the many myths and clinician uncertainty that surround what recommendations should be given to the breastfeeding mother when she is to either continue her needed chronic maintenance medication(s) and/or start a new medication(s) for acute or chronic treatment. Unfortunately, and mostly due to a lack of factual knowledge, many clinicians will simply, often in a cavalier fashion, recommend temporary or even permanent discontinuation of breastfeeding with maternal drug therapy so as to simply avoid any possible complications. Ito18 effectively and thoroughly reviews the importance of breastfeeding, the PK principles of drug distribution into breast milk, infant exposure through feeding, infant PK, and possible PD effects. Ito uses real-world case studies of underlying maternal illness requiring drug treatment while breastfeeding to highlight many important nuances to consider in making a clinical decision to continue or stop breastfeeding—the risk-benefit analysis. Further emphasis is focused on opioids and frequently prescribed analgesics during breastfeeding. Concluding this supplement is an excellent paper by Liu and colleagues19 focusing on probiotics and their use in fostering/supporting good health and for the prevention and treatment of disease. Tremendous excitement surrounds the mainstream medicinal use of pre- and probiotics. Evidence continues to amass regarding their benefit in the amelioration and treatment of certain pediatric diseases, and the authors critically assess available data pertaining to their effects on five important pediatric diseases/disorders: necrotizing enterocolitis, acute infectious diarrhea, acute respiratory tract infections, antibiotic-associated diarrhea, and infant colic. Clearly, what constitutes the optimal “mixture” of live organisms and correct “dose” for specific diseases remains to be determined, though Liu and colleagues methodically sift through available data specific to particular uses and address six “myths and mysteries” surrounding this global area of therapeutics. Next steps that can be taken with these products to better define their role in therapeutics are offered. We thank the authors of each contribution to this supplement for their strong commitment to providing complete and comprehensive reviews of their topic areas and so clearly integrating mechanistic components with clinical relevance and applicability. We hope you, the reader, will glean new ideas, formulate new approaches, and design new strategies to institute in your respective areas of practice to continue to advance the optimal care of the pediatric patient." @default.
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• W2893289265 date "2018-09-24" @default.
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• W2893289265 title "Developmental Pharmacotherapy: The Interface Between Ontogeny and Drug Effect" @default.
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• W2893289265 doi "https://doi.org/10.1002/jcph.1317" @default.
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