Suggestions for Model‐Informed Precision Dosing to Optimize Neonatal Drug Therapy

Euteneuer, Joshua C.; Kamatkar, Suyog; Fukuda, Tsuyoshi; Vinks, Alexander A.; Akinbi, Henry T.

doi:10.1002/jcph.1315

Cited by 24 publications

(18 citation statements)

References 61 publications

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“…The frequency of titration to target response was initially unexpected, but these 3 approaches may reflect the movement toward precision medicine in both adult and pediatric therapeutics. Recent publications in pediatric oncology, 25 pediatric infectious disease, 26 and neonatal medicine 27 suggest that this is a positive move toward dealing with the complexity of pediatric therapeutics and dosing for a population varying from extremely premature neonates to adolescents. Therapeutic drug monitoring for pediatric drug development is also still an option 28 but also may have been a precursor to current precision dosing programs.…”

Section: Discussionmentioning

confidence: 99%

Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Green

Park

Burckart

2021

The Journal of Clinical Pharma

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Dosing is a critical aspect of drug development in pediatrics that has led to trial failures and the inability to label the drug for pediatric use by the US Food and Drug Administration. Developing a structured approach for pediatric dose selection requires knowledge of the current approaches and their success or failure. This study describes the current experience with pediatric dosing methods from 2012 to 2020 and had 2 primary objectives: (1) to identify how the initial pediatric dose was selected and (2) to identify the pivotal dosing strategy used to identify the initially selected dose for safety and efficacy for pediatric clinical trials. Through September 2020, a total of 275 pediatric drug development programs were characterized for initial and pivotal dosing strategies. The success rate for labeling for pediatric use was 76.4%. The most common initial dosing strategy was previous experience with the product, followed by allometric scaling and exposure matching with adults. The most common pivotal dosing strategy was titration to target response in 33% of programs, with the second and third most common being pharmacokinetic/pharmacodynamic studies (30%) and exposure matching (20%), respectively. Additionally, about one‐half of pediatric programs incorporated model‐informed drug development. The emergence of titration to target response may signal a shift toward precision medicine in pediatric patients. Future work in pediatric drug dose selection should move toward the development of a structured pediatric dose selection approach.

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Section: Discussionmentioning

confidence: 99%

Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Green

Park

Burckart

2021

The Journal of Clinical Pharma

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“… 238 , 239 , 240 , 241 , 242 , 243 , 244 The changes vary with the setting of renal replacement therapy 245 , 246 , 247 , 248 ; however, it has been pointed out that the doses recommended for renal replacement therapy may be insufficient. 246 , 249 , 250 , 251 , 252 , 253 , 254 , 255 …”

Section: Methods Used For Creating This Guidelinementioning

confidence: 99%

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J‐SSCG 2020)

Egi

Ogura

Yatabe

et al. 2021

Acute Medicine & Surgery

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The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J‐SSCG 2020), a Japanese‐specific set of clinical practice guidelines for sepsis and septic shock created as revised from J‐SSCG 2016 jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in September 2020 and published in February 2021. An English‐language version of these guidelines was created based on the contents of the original Japanese‐language version. The purpose of this guideline is to assist medical staff in making appropriate decisions to improve the prognosis of patients undergoing treatment for sepsis and septic shock. We aimed to provide high‐quality guidelines that are easy to use and understand for specialists, general clinicians, and multidisciplinary medical professionals. J‐SSCG 2016 took up new subjects that were not present in SSCG 2016 (e.g., ICU‐acquired weakness [ICU‐AW], post‐intensive care syndrome [PICS], and body temperature management). The J‐SSCG 2020 covered a total of 22 areas with four additional new areas (patient‐ and family‐centered care, sepsis treatment system, neuro‐intensive treatment, and stress ulcers). A total of 118 important clinical issues (clinical questions, CQs) were extracted regardless of the presence or absence of evidence. These CQs also include those that have been given particular focus within Japan. This is a large‐scale guideline covering multiple fields; thus, in addition to the 25 committee members, we had the participation and support of a total of 226 members who are professionals (physicians, nurses, physiotherapists, clinical engineers, and pharmacists) and medical workers with a history of sepsis or critical illness. The GRADE method was adopted for making recommendations, and the modified Delphi method was used to determine recommendations by voting from all committee members. As a result, 79 GRADE‐based recommendations, 5 Good Practice Statements (GPS), 18 expert consensuses, 27 answers to background questions (BQs), and summaries of definitions and diagnosis of sepsis were created as responses to 118 CQs. We also incorporated visual information for each CQ according to the time course of treatment, and we will also distribute this as an app. The J‐SSCG 2020 is expected to be widely used as a useful bedside guideline in the field of sepsis treatment both in Japan and overseas involving multiple disciplines.

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“…Furthermore, antimicrobial drug concentrations also change when renal replacement therapy is initiated [ 276 – 282 ]. The changes vary with the setting of renal replacement therapy [ 283 – 286 ]; however, it has been pointed out that the doses recommended for renal replacement therapy may be insufficient [ 284 , 287 – 293 ].…”

Section: Methods Used For Creating This Guidelinementioning

confidence: 99%

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J-SSCG 2020)

et al. 2021

View full text Add to dashboard Cite

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J-SSCG 2020), a Japanese-specific set of clinical practice guidelines for sepsis and septic shock created as revised from J-SSCG 2016 jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in September 2020 and published in February 2021. An English-language version of these guidelines was created based on the contents of the original Japanese-language version. The purpose of this guideline is to assist medical staff in making appropriate decisions to improve the prognosis of patients undergoing treatment for sepsis and septic shock. We aimed to provide high-quality guidelines that are easy to use and understand for specialists, general clinicians, and multidisciplinary medical professionals. J-SSCG 2016 took up new subjects that were not present in SSCG 2016 (e.g., ICU-acquired weakness [ICU-AW], post-intensive care syndrome [PICS], and body temperature management). The J-SSCG 2020 covered a total of 22 areas with four additional new areas (patient- and family-centered care, sepsis treatment system, neuro-intensive treatment, and stress ulcers). A total of 118 important clinical issues (clinical questions, CQs) were extracted regardless of the presence or absence of evidence. These CQs also include those that have been given particular focus within Japan. This is a large-scale guideline covering multiple fields; thus, in addition to the 25 committee members, we had the participation and support of a total of 226 members who are professionals (physicians, nurses, physiotherapists, clinical engineers, and pharmacists) and medical workers with a history of sepsis or critical illness. The GRADE method was adopted for making recommendations, and the modified Delphi method was used to determine recommendations by voting from all committee members.As a result, 79 GRADE-based recommendations, 5 Good Practice Statements (GPS), 18 expert consensuses, 27 answers to background questions (BQs), and summaries of definitions and diagnosis of sepsis were created as responses to 118 CQs. We also incorporated visual information for each CQ according to the time course of treatment, and we will also distribute this as an app. The J-SSCG 2020 is expected to be widely used as a useful bedside guideline in the field of sepsis treatment both in Japan and overseas involving multiple disciplines.

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Suggestions for Model‐Informed Precision Dosing to Optimize Neonatal Drug Therapy

Cited by 24 publications

References 61 publications

Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J‐SSCG 2020)

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J-SSCG 2020)

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