Sachs HC - Search Results

1

Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development.

Zhao S, Gockenbach M, Grimstein M, Sachs HC, Mirochnick M, Struble K, Belew Y, Wang J, Capparelli EV, Best BM, Johnson T, Momper JD, Maharaj AR. Zhao S, et al. Among authors: sachs hc. Front Pediatr. 2021 Oct 13;9:721059. doi: 10.3389/fped.2021.721059. eCollection 2021. Front Pediatr. 2021. PMID: 34722417 Free PMC article.

2

Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019.

Khong YM, Liu J, Cook J, Purohit V, Thompson K, Mehrotra S, Cheung SYA, Hay JL, Fletcher EP, Wang J, Sachs HC, Zhu H, Siddiqui A, Cunningham L, Selen A. Khong YM, et al. Among authors: sachs hc. Eur J Pharm Biopharm. 2021 Jul;164:66-74. doi: 10.1016/j.ejpb.2021.04.010. Epub 2021 Apr 18. Eur J Pharm Biopharm. 2021. PMID: 33878434

3

Exposure-Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration.

Zhang Y, Wang Y, Khurana M, Sachs HC, Zhu H, Burckart GJ, Alexander J, Yao LP, Wang J. Zhang Y, et al. Among authors: sachs hc. Clin Pharmacol Ther. 2020 Jul;108(1):90-98. doi: 10.1002/cpt.1809. Epub 2020 Mar 16. Clin Pharmacol Ther. 2020. PMID: 32030741

4

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Mulugeta YL, Zajicek A, Barrett J, Sachs HC, McCune S, Sinha V, Yao L. Mulugeta YL, et al. Among authors: sachs hc. Pediatr Clin North Am. 2017 Dec;64(6):1185-1196. doi: 10.1016/j.pcl.2017.08.015. Pediatr Clin North Am. 2017. PMID: 29173779 Free PMC article. Review.

5

Drug development for pediatric neurogenic bladder dysfunction: dosing, endpoints, and study design.

Momper JD, Karesh A, Green DJ, Hirsch M, Khurana M, Lee J, Kim MJ, Mulugeta Y, Sachs HC, Yao L, Burckart GJ. Momper JD, et al. Among authors: sachs hc. J Clin Pharmacol. 2014 Nov;54(11):1239-46. doi: 10.1002/jcph.345. Epub 2014 Jun 24. J Clin Pharmacol. 2014. PMID: 24922179

6

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

Sun H, Lee JJ, Papadopoulos EJ, Lee CS, Nelson RM, Sachs HC, Rodriguez WJ, Mulberg AE. Sun H, et al. Among authors: sachs hc. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):12-7. doi: 10.1097/MPG.0000000000000186. J Pediatr Gastroenterol Nutr. 2014. PMID: 24121142

7

The transfer of drugs and therapeutics into human breast milk: an update on selected topics.

Sachs HC; Committee On Drugs. Sachs HC, et al. Pediatrics. 2013 Sep;132(3):e796-809. doi: 10.1542/peds.2013-1985. Epub 2013 Aug 26. Pediatrics. 2013. PMID: 23979084

8

Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.

Momper JD, Mulugeta Y, Green DJ, Karesh A, Krudys KM, Sachs HC, Yao LP, Burckart GJ. Momper JD, et al. Among authors: sachs hc. JAMA Pediatr. 2013 Oct;167(10):926-32. doi: 10.1001/jamapediatrics.2013.465. JAMA Pediatr. 2013. PMID: 23921678

9

Strategic biomarkers for drug development in treating rare diseases and diseases in neonates and infants.

Bai JP, Barrett JS, Burckart GJ, Meibohm B, Sachs HC, Yao L. Bai JP, et al. Among authors: sachs hc. AAPS J. 2013 Apr;15(2):447-54. doi: 10.1208/s12248-013-9452-z. Epub 2013 Jan 19. AAPS J. 2013. PMID: 23334978 Free PMC article. Review.

10

Neonatal drug withdrawal.

Hudak ML, Tan RC; COMMITTEE ON DRUGS; COMMITTEE ON FETUS AND NEWBORN; American Academy of Pediatrics. Hudak ML, et al. Pediatrics. 2012 Feb;129(2):e540-60. doi: 10.1542/peds.2011-3212. Epub 2012 Jan 30. Pediatrics. 2012. PMID: 22291123

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