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3. How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

Author

Severin, Thomas, Corriol-Rohou, Solange, Bucci-Rechtweg, Christina, an Haack, Kristina, Fuerst-Recktenwald, Sabine, Lepola, Pirkko, Norjavaara, Ensio, Dehlinger-Kremer, Martine, Haertter, Sebastian, and Cheung, S. Y. Amy

Abstract

Background: Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development. Methods: The EFGCP Children’s Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs. Results: Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified. Conclusion: Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.

Published
2024
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16. Pubertal timing is an independent predictor of central adiposity in young adult males: the Gothenburg 0steoporosis and obesity determinants study

Author

Kindblom, Jenny M., Lorentzon, Mattias, Norjavaara, Ensio, Lonn, Lars, Brandberg, John, Angelhed, Jan-Erik, Hellqvist, Asa, Nilsson, Staffan, and Ohlsson, Claes

Subjects
Obesity -- Risk factors, Metabolic syndrome X -- Risk factors, Diabetes -- Risk factors, Health, Risk factors
Abstract

The role of puberty and normal variations in pubertal timing for the development of obesity in men is unclear. The aim of the current study was to investigate the impact of pubertal timing and prepubertal BMI (kg/[m.sup.2]) for young adult BMI and fat mass distribution. Detailed growth charts from birth to age 18-20 years were retrieved for the men participating in the population-based Gothenburg Osteoporosis and Obesity Determinants study. Age at peak height velocity (PHV) and BMI at age 10 years were estimated for 579 subjects, and PHV was used as an assessment of pubertal timing. The fat mass characterization and distribution were analyzed using dual X-ray absorptiometry and peripheral as well as abdominal computed tomography at age 18.9 ± 0.5 years. We demonstrate that age at PHV is an independent negative predictor of young adult BMI and whole-body fat mass. Interestingly, age at PHV is an independent negative predictor of central, but not peripheral, fat mass. In contrast, BMI at 10 years of age predicts both central and peripheral subcutaneous fat mass. In conclusion, we demonstrate that early pubertal onset specifically predicts a central fat mass distribution, while a predominantly subcutaneous obese phenotype is strongly predicted by a high prepubertal BMI. Diabetes 55: 3047-3052, 2006, Obesity has grown into an epidemic in the Western world, and not only adults but also children are now treated for metabolic syndrome disorders. Obesity is an important risk factor [...]

Published
2006

24. Twenty-four hours secretion pattern of serum estradiol in healthy prepubertal and pubertal boys as determined by a validated ultra-sensitive extraction RIA

Author

Norjavaara Ensio and Ankarberg-Lindgren Carina

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Abstract Background The role of estrogens in male physiology has become evident. However, clinically useful normative data for estradiol secretion in boys has not previously been established due to the insensitivity of current methods used in clinical routine. By use of a validated ultra-sensitive extraction RIA, our aim was to establish normative data from a group consisting of healthy boys in prepuberty and during pubertal development. Methods Sixty-two 24-hours serum profiles (6 samples/24 hours) were obtained from 44 healthy boys (ages; 7.2–18.6 years) during their pubertal development, classified into five stages: prepuberty (testis, 1–2 mL), early (testis, 3–6 mL), mid (testis, 8–12 mL), late-1 (testis,15–25 mL, not reached final height) and late-2 (testis,15–25 mL, reached final height). Serum estradiol was determined by an ultra- sensitive extraction radioimmunoassay with detection limit 4 pmol/L and functional sensitivity 6 pmol/L. Results Mean estradiol concentrations during 24-hours secretion increased from prepuberty (median: Conclusion With the use of an ultra-sensitive extraction RIA, we have provided clinically useful normative data for estradiol secretion in boys.

Published
2008
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