As we begin our 29th volume, The Journal of Pediatric Pharmacology and Therapeutics, or JPPT, will continue to serve as the primary forum advocating for optimal pharmacotherapeutics in all segments of pediatric health care—care addressing illness in the premature infant through adolescence. JPPT will remain the source for authoritative, comprehensive topic reviews, timely original research communications, brief (practice) reports, and a place for informative, abbreviated research reports and clinical vignettes. The Journal will continue to publish high-quality, informative, impactful manuscripts that move our knowledge base forward in the treatment of sick infants and children. In support of these ideals, JPPT will remain a no-fee, fully open-access publication. Recognizing the many challenges confronting open-access publications and to support JPPT, the Journal welcomes voluntary article processing payments, in any amount, if author’s institutions and/or their granting agency has funds available for publication. The availability of such volunteer payments will of course, have no impact on peer review or publication decisions but will aid in supporting the continued open-access stability of the Journal in this highly volatile, competitive publication landscape.Volume 29 ushers in several new initiatives for the Journal and our readership. I am pleased to announce that we now have a full complement of highly talented specialty/subspeciality expert editors. The individuals and their respective editorial roles can be viewed on our masthead contained in the “Table of Contents” PDF link that appears at the bottom of each issue page. Our newest section editor, Caitlyn Bradford, will focus her talents on expanding JPPT’s social media presence, enhancing the timely global visibility of JPPT publications. The Journal’s editors are committed to rapid expert peer review and prompt editorial decisions furthering rapid publication. We will continue to implement processing procedures to minimize the time from submission to publication. One means of accomplishing this goal starting with volume 29 is the availability of optional online-first publication. Authors of accepted manuscripts will have the option of having their manuscript, with an assigned DOI number, published as an online first publication, prior to publication in an upcoming issue, for a nominal fee that covers the associated costs. In addition, we are beginning a live “Meet the Author” webinar series where readers will have the opportunity to hear from, chat with, and have their questions answered, in real time, by an author of a manuscript recently published in JPPT. More information about this new initiative and a timetable will be posted on our Web site.Starting with volume 29, JPPT will be published 6 times per year. Journal issues will be published the second week of the second month. This change will have no impact on time to publication and we will continue to publish the same number of, if not more, manuscripts per year than in previous volumes. Our manuscript categories, for example, Education/Review, Research, etc, will remain unchanged. However, we are beginning the regular publication of peer-reviewed commentaries by recognized experts who offer their insight, interpretation, and forward-thinking opinions of contemporary issues impacting pediatric practice. Although the initiation of this new series has involved invited commentaries, the Journal welcomes submissions of unsolicited evidence-based commentaries where experts comment on topics important to pediatric pharmacotherapeutics. Those interested in contributing a commentary should consult with the JPPT editor-in-chief prior to submission to ensure the topic is appropriate for the Journal and not duplicative of current efforts. Further, all authors submitting manuscripts for JPPT consideration are requested to carefully review and adhere to our updated Instructions to Authors. Submitting a manuscript for consideration that adheres to these author guidelines will minimize the time to editorial decision and publication.It is a privilege for me to serve as your editor-in-chief. However, I could not do what I do without the unwavering support and commitment of my editorial “dream team.” These 6 individuals are staunchly committed to everything addressed in this editorial, and they remain focused on the coordinated, methodical growth of our forward-thinking Journal. They are also a joy to work with. In addition, I want to acknowledge the efforts of our International Editorial Board members, the Pediatric Pharmacy Association (PPA) Board of Directors, who remain fully committed to ensuring the stability and maintenance of our open-access publication, and to our expert peer-reviewers, who dedicate their time in shaping the Journal’s trajectory. The collective efforts of all these individuals and the PPA are reflected in the health and excellence of our publication and in refining our continually evolving forward vision for The Journal of Pediatric Pharmacology and Therapeutics, JPPT, in the many years ahead.None

The hot topic of the day at the (real or virtual) water cooler, rounding on the wards, in the intensive care units, in the lay press, and most importantly for our JPPT readership, and the academic and scientific publishing communities, is artificial intelligence (AI)—the many and soon to be more numerous, AI platforms. Everyone’s talking about AI and how it will affect imeverything we do, how it can and will impact the world we live in. The good, the bad, the ugly. The frenzy, the many concerns… has HAL from 2001: A Space Odyssey arrived? Is the Terminator cyborg really coming, or is “it” already here… “it” did say, “I’ll be back”!! Many questions exist about these technologies; the many platforms; their outputs including what roles they may have, positive and negative; and the affect AI will have in every segment of the publishing world. As experience is gained with the use of these technology platforms, many more detailed and directed questions will be raised, leading to a better understanding of their true roles in research, research integrity, and publication, all combined with their many ethical perturbations.Large language models (LLMs) like ChatGPT (Generative Pre-trained Transformer) and others using natural language–processing (NLP) technology are consuming the conversation worldwide with emotions of bliss and excitement for the tremendous potential these tools can afford for the good of society combined with appropriate skepticism, even fear and terror as to their negative, immense destructive potential. ChatGPT was released to the public, open access, in November 2022 by its developer, OpenAI, to much fanfare, concern, and astonishment. However, it is important to note that AI has been with us for many years. Artificial intelligence is, and has been, integrated into multiple functions we already depend on daily, for example, our search engines, Siri, Alexa, biometrics, automated customer services, and much, much more. What is new is the state of their development, these tools’ capacity, and the continuously evolving sophistication of their machine learning capabilities to create—in seconds—polished, believable, output. Much food for our collective thought.ChatGPT is just one of many natural language “bots” that are continuously trained on large amounts of data extracted from multiple sources including the worldwide web (e.g., published articles of all sorts, books, Wikipedia and using NLP to simulate human conversation, thus “allowing the user to chat with the machine intuitively.”1 Like a PubMed search, one introduces a few, specific key words or terms and within seconds, the tool constructs a readable, believable and if done correctly, comprehensive text, including complicated, sophisticated medical and scientific research analysis and writing. In this regard, these self-learning tools can help, or even direct, investigators to identify the research question, refine and focus the study hypothesis, design optimal study logistics, analyze the data, and even write the paper—from Introduction through Methods and Results, to completing a data-driven, compelling Discussion section with specific recommendations ready for peer review and ultimate publication in the peer-reviewed literature. Oh yea, these tools can easily and rapidly address those sometimes confusing, journal-specific Author Instructions, construct and populate data tables, and design figures that effectively display the Results, all in a manner of seconds. Wow—what is not to like! Well… let’s stop and take a moment (or many) to think about all the large and small ramifications as there are many real issues, known and yet to be defined, that relate to research performance and resultant publication, including their many deficiencies, that is, plagiarism, inaccuracies, and fabricated output. To date, these technologies cannot totally remove the human interface for these functions but, what is next?The expansion of chatbot and NLP technology is just one of many contemporary challenges confronting the entire publication continuum from educators, investigators, to authors, peer reviewers, journal editors, their publishers, and above all, the reader. Like all technologic tools, thoughtful, realistic, easy to use, appropriate guardrails are needed to foster their greatest benefits while trying to limit the serious negatives that inevitably link with such innovations. On May 5, 2023, the US Food and Drug Administration released its discussion paper and request for feedback for “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.”2 On May 16, 2023, Sam Altman, OpenAI CEO, testified before a US Senate subcommittee addressing the positive, nefarious, and destructive potential of ChatGPT and other AI models.3 Recently, Brad Smith, president of Microsoft Corp, opined on the acute need for corporate and government regulation of this technology.4 (Microsoft is an investor in ChatGPT). To complicate this landscape further, Meta, the parent company of Facebook, in February 2023, made its AI technology available “as open-access software—computer code that can be freely copied, modified, and reused—­providing outsiders with everything they need to quickly build chatbots on their own.”5 This is just the beginning, and it is sobering. I strongly encourage everyone to remain up-to-date with the many available platforms and their capabilities, both positive and negative.To gain a good understanding of the roles LLM bots have today, and the roles they can and will play in all segments of pharmacy, medicine, clinical pharmacology, and toxicology research and practice, with a focus on scientific publication, readers are directed to a few excellent editorials by authorities representing recognized publications.1,6–11 Moreover, numerous papers and online first publications address uses as well as raising many questions regarding AI use. Biswas12 published a very enlightening, succinct commentary titled “ChatGPT and the Future of Medical Writing.” For the reader who wants an introduction to this topic, I recommend reading this brief, provocative commentary and searching the medical literature for more on this evolving topic.Recognizing the importance of AI to academic and scientific writing and subsequent publication, and the inability, at present, to effectively detect “bot”-written papers*, JPPT is instituting the following guidelines for authors regarding AI use in a manuscript submitted for potential publication in JPPT:ChatGPT or any AI/LLM tool is not an author and cannot be listed as an author or co-author of a JPPT manuscript because such tools cannot meet our standards for authorship.The use of any AI/LLM tools in any aspect of manuscript content including, but not limited to, study protocol design, study implementation, data collection, and data analysis, must be clearly acknowledged and specifically outlined in the Methods section. This includes stating the exact tool names, version numbers, manufacturers, and roles used.The use of any AI/LLM tools in any other aspect of a submitted manuscript, including, but not limited to, assisting with the writing, actually writing sections, correcting grammar, editing language, or any other use, must be completely outlined in the Acknowledgment section of the manuscript including the exact tool names, version numbers, manufacturers, and roles.JPPT always has and continues to expect total transparency by authors in the Methods and Acknowledgment sections, that is, complete and comprehensive descriptions of every aspect of their research, and from manuscript preparation to submission where appropriate.I remind all authors of manuscripts submitted for publication in JPPT of their responsibilities and accountability for the accuracy and integrity of their data and text.AI/LLM tools are here, continuously evolving with newer, expanded capabilities with each new platform, and they are here to stay. We cannot ignore these tools; rather we need to embrace this technology and monitor, define, and determine their proper, optimal, and ethical uses. As these tools are continuously evolving, so too is our assessment of the roles for AI/LLM as well as what will be an acceptable amount of AI input into manuscripts published in JPPT. The above guidelines represent our initial recommendations, knowing these too will evolve. The JPPT editorial leadership will keep our readership informed of all modifications.The JPPT editorial leadership team for constantly providing insightful, sage recommendations combined with their unwavering commitment to the thoughtful, steady growth and development of JPPT. I could not perform my role as editor without them.

Clinical therapeutics during pregnancy typically focuses on maternal or fetal disease with only passing attention to the placenta as a potential target. This chapter briefly reviews the history of targeting the placenta for therapeutics and offers some thoughts on current and future opportunities for treating the placenta.

Introduction Three major classes of natural products (NPs) for medicinal purposes or improving wellbeing are generally available in the US: conventional drugs of herbal origin, botanical drugs, and dietary supplements (DSs). Consumer consumption of DSs is growing annually. The U.S. FDA regulates conventional and botanical drugs for safety and efficacy; however, DSs are minimally regulated.Areas covered This article will: i) highlight the importance of NP as a significant source of prescription drugs; ii) discuss differences in the regulation of conventional drugs of NP product, botanical drugs, and DSs; iii) discuss the safety and efficacy of DSs and iv) make recommendations for improvement of safety for minimally regulated NPs.Expert opinion Toxicities associated with the use of NPs, including vitamins and DSs, are mainly due to excessive use and interactions with conventional drug(s) and may represent challenges for clinicians. Conventional and botanical-based prescription drugs are rarely associated with unknown toxicities. However, DSs are minimally regulated and can produce severe adverse effects. We believe that clinical pharmacologists can have a role in developing criteria for DS safety analysis. There is also the potential for a standardized NP stewardship program(s) and the development of NP policies and practices nationally and globally.

Copyright © 2020 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

Charcot deformity is a challenge that foot and ankle surgeons struggle to manage successfully. Despite the advances in knowledge, technology, and treatment modalities, limb loss is still greater than 10%. This article discusses the efficacy of conservative measures and traditional surgical approaches. It proposes a multidisciplinary team approach, medical optimization, and lifestyle modification to put the patient in the best position to heal. Also discussed is the authors' staged surgical treatment protocol to enhance outcomes and decrease the rate of limb loss.

Quantitative systems pharmacology (QSP) is a novel approach to gain insights into the pathophysiology of a disease, optimize the efficacy of therapies and reduce the risk for new drug development. Together with Grünenthal, Rosa developed a QSP model, a Psoriasis PhysioPD Research Platform to mechanistically represent the physiology of a single chronic psoriatic plaque (including keratinocytes, immune cells, cytokines and chemokines and their regulation), drug PK and clinical outcomes (e.g., PASI score). The Platform was qualified against standard of care (SOC) therapies. Simulations provided insights into the therapeutic potential and efficacy of novel small molecule enzyme-specific inhibitors. Sensitivity analysis identified pathways critical for plaque healing. Best- and worst-case scenarios and the impact of target-related uncertainties were evaluated in a cohort of Virtual Patients. Research in the Platform identified uncertainties related to target expression in immune and skin cells, and to drug distribution and availability in the skin. Treatment simulation helped to define the specific conditions under which the novel therapeutic approach would be superior to SOC treatments and to identify in vivo experiments for reducing risk throughout the process of drug development. The in silico research and analysis revealed key conditions under which the novel treatment would offer superior efficacy compared to SOC and identified experiments to confirm these conditions in vivo. The developed Platform is a viable tool for evaluating early-stage drug candidates and reducing the risk for late-stage development.

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.

Skin diseases range from benign to life threatening and affect most people at some life stage. Despite recent advances, many mechanistic details of etiology and pathogenesis remain to be elucidated and there is a need to increase research efficiency for advancement of new treatments. Mechanistic physiological modeling can help to meet these needs. Rosa’s PhysioPD™ Platforms are graphical, mathematical models that incorporate engineering approaches and scientific data analysis to clarify physiology and drug interactions. Simulated experiments can be used to test hypotheses, elucidate the connections between drug action and physiological outcomes, explore the efficacy, toxicity, and therapeutic dose range, select the correct drug targets, and the patient target population. When used in conjunction with preclinical and clinical research, this can provide a rigorous method for advancing dermatologic research. With participation from industry clients, we have studied acne, atopic dermatitis (AD), psoriasis, skin aging, and erythema in over a dozen research projects. For example, in AD, PhysioPD research was used to clarify mechanisms of action and help prioritize acquired assets for development. In acne, in sillico research identified sebogenesis and inflammation as top drivers for acne pathophysiology and demonstrated that only one compound out of three was likely to be superior to the standard of care. In skin aging, a sensitivity analysis highlighted hyaluronic acid and other key drivers for improvements in skin appearance as promising treatment targets. Each research project has elucidated interactions between skin structure/function and immunology and enabled investigation of hypotheses linking pathologies to clinical outcome scores, e.g., SCORAD. In the context of dermatology R&D, mechanistic modeling is an efficient way to increase confidence in a candidate therapy and enables a focused use of resources.

The Best Pharmaceuticals for Children Act of 2002 mandated that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) carries out critical reviews of the gaps in knowledge and unmet needs regarding safe and effective pharmacologic treatment of infants, children, and adolescents in a broad range of disease areas. In 2012, NICHD selected diabetes mellitus as one of the pediatric disorders for review. Dr. William V. Tamborlane was named chair, and Dr. Linda DiMeglio, vice-chair, of the Diabetes Working Group. Together with Dr. George Giacoia of NICHD, they assembled a distinguished group of medical experts in childhood diabetes, including clinicians/clinical investigators from leading academic centers and from industry and representatives from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), to carry out this review. It is very important to note that the views expressed in this article, as well as in other reports from the Diabetes Working Group, are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the FDA or EMA or any of the organizations or pharmaceutical companies represented in our working group. As shown in Supplementary Table 1, the large Diabetes Working Group was divided into five committees: Type 1 Diabetes (T1D): Therapeutics, Type 2 Diabetes (T2D): Therapeutics, T1D: Natural History and Biomarkers, T2D: Natural History and Biomarkers, and Diabetes Pharmacology. The consensus of the T2D Therapeutics Committee was that its efforts should address the crisis in care that clinicians face in treating this disorder in adolescents. Despite a plethora of new drug classes and new agents within each class that have been approved for use in adults with T2D, in …

Background: This study examined the degree to which individuals' sense of self-determination and internal locus of control might be suitable constructs to study in relation to fine arts participation in adults with complex developmental disabilities. Method: Thirty-four participants in fine arts programs and eight non-participants, all with disabilities involving neuromuscular impairment and varying degrees of cognitive impairment, completed measures of locus of control and of sense of self-determination. Results: No significant differences on quantitative measures were found among high users, low users or non-users of arts programming. Qualitative results suggest that fine arts participants, relative to non-participants, are more likely to de-emphasize "luck" in favor of effort and ambition in attributions about their circumstances and accomplishments. Conclusion: While quantitative findings did not suggest a relationship between either self-determination or locus of control and arts participation, the qualitative findings suggest that the constructs might be useful ones to study in relation to arts participation.

ObjectiveTo explore the relationship between medroxyprogesterone acetate (MPA) pharmacokinetic (PK) parameter estimates and weight gain.Study designProspective study of adolescents (N=40; age 12–21 years) initiating DMPA. PK parameters were calculated: maximum MPA concentration (Cmax, ng/mL), time to Cmax (Tmax, days) and elimination rate constant (ng/mL/day). Optimal PK cut points were determined for predicting body mass index (BMI) increase ≥10%.ResultsCmax <2.88 ng/mL and elimination rate constant <0.021 ng/mL/day were associated (p<.05) with BMI increase ≥10%. Elimination rate constant was most predictive of weight gain.ConclusionsPK evaluation may help identify adolescents at risk of excessive DMPA-associated weight gain.