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Literature DB >> 29029810

Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act.

Debbie Avant¹, Gerold T Wharton², Dianne Murphy².

Abstract

Entities: Chemical Disease Species

Keywords: FDA; Pediatric clinical trials; pediatric drug development; pediatric labeling

Mesh：

Year: 2017 PMID： 29029810 PMCID： PMC5732867 DOI： 10.1016/j.jpeds.2017.08.048

Source DB: PubMed Journal: J Pediatr ISSN： 0022-3476 Impact factor: 4.406

× No keyword cloud information.

7 in total

1. An update on the therapeutic orphan.

Authors: J T Wilson
Journal: Pediatrics Date: 1999-09 Impact factor: 7.124

2. Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

Authors: Daniel K Benjamin; Philip Brian Smith; M Dianne Murphy; Rosemary Roberts; Lisa Mathis; Debbie Avant; Robert M Califf; Jennifer S Li
Journal: JAMA Date: 2006-09-13 Impact factor: 56.272

3. Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials.

Authors: Haihao Sun; Jessica J Lee; Elektra J Papadopoulos; Catherine S Lee; Robert M Nelson; Hari C Sachs; William J Rodriguez; Andrew E Mulberg
Journal: J Pediatr Gastroenterol Nutr Date: 2014-01 Impact factor: 2.839

4. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

Authors: Gerold T Wharton; M Dianne Murphy; Debbie Avant; John V Goldsmith; Grace Chai; William J Rodriguez; Eric L Eisenstein
Journal: Pediatrics Date: 2014-07-14 Impact factor: 7.124

Review 5. Pediatric cardiovascular drug trials, lessons learned.

Authors: Jennifer S Li; Michael Cohen-Wolkowiez; Sara K Pasquali
Journal: J Cardiovasc Pharmacol Date: 2011-07 Impact factor: 3.105

6. The impact of the written request process on drug development in childhood cancer.

Authors: Kristen M Snyder; Gregory Reaman; Debbie Avant; Richard Pazdur
Journal: Pediatr Blood Cancer Date: 2013-01-17 Impact factor: 3.167

7. Pediatric antihypertensive trial failures: analysis of end points and dose range.

Authors: Daniel K Benjamin; P Brian Smith; Pravin Jadhav; Jogarao V Gobburu; M Dianne Murphy; Vic Hasselblad; Carissa Baker-Smith; Robert M Califf; Jennifer S Li
Journal: Hypertension Date: 2008-03-10 Impact factor: 10.190

7 in total

8 in total

8. Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial): A Randomized Controlled Trial: Background, Aims and Study Protocol.

Authors: Mariana Baserga; Tara L DuPont; Betsy Ostrander; Stephen Minton; Mark Sheffield; Alfred H Balch; Timothy M Bahr; Kevin M Watt
Journal: Front Pain Res (Lausanne) Date: 2021-12-07

8 in total

Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act.

1. An update on the therapeutic orphan.

2. Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

3. Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials.

4. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

Review 5. Pediatric cardiovascular drug trials, lessons learned.

6. The impact of the written request process on drug development in childhood cancer.

7. Pediatric antihypertensive trial failures: analysis of end points and dose range.

Review 1. Pediatric Clinical Endpoint and Pharmacodynamic Biomarkers: Limitations and Opportunities.

2. Assessing Drug Safety in Children - The Role of Real-World Data.

Review 3. Prescribing drugs to overweight and obese children: Balancing efficacy and safety.

Review 4. Pharmacokinetics of nanotechnology-based formulations in pediatric populations.

5. Developing a pediatric pain data repository.

6. The best pharmaceuticals for children-what can we do?

7. Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic.

8. Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial): A Randomized Controlled Trial: Background, Aims and Study Protocol.