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Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report.

• Authors : Bai JPF; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Liu G

Subjects: United States Food and Drug Administration* ; Drug Development*/Drug Development*/Drug Development*/methods ; Network Pharmacology*

• Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Dec; Vol. 13 (12), pp. 2102-2110. Date of Electronic Publication: 2024 Oct 18.Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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FDA regulatory considerations for oncology drug development.

• Authors : Moon H; MediRama, Inc., Seoul, South Korea.; Zang DY

Subjects: United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/legislation & jurisprudence ; Drug Development*/Drug Development*/Drug Development*/legislation & jurisprudence ; Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/therapeutic use

• Source: Pharmacology research & perspectives [Pharmacol Res Perspect] 2024 Aug; Vol. 12 (4), pp. e1254.Publisher: John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics Country of Publication: United States

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Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development.

• Authors : Gao W; Quantitative Pharmacology, EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.; Liu J

Subjects: Drug Development*/Drug Development*/Drug Development*/methods ; Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/administration & dosage ; Neoplasms*/Neoplasms*/Neoplasms*/drug therapy

• Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 May; Vol. 13 (5), pp. 691-709. Date of Electronic Publication: 2024 Mar 21.Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020.

• Authors : Abulwerdi GA; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Ramamoorthy A

Subjects: Drug Approval* ; Drug Development*; Adult

• Source: Clinical and translational science [Clin Transl Sci] 2023 Oct; Vol. 16 (10), pp. 2046-2057. Date of Electronic Publication: 2023 Aug 18.Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print-Electronic Cited Medium: Internet

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Flexible Development Programs for Antibacterial Drugs to Address Unmet Medical Needs.

• Authors : Ghosh M; Iarikov D; Qi XK

Subjects: Anti-Bacterial Agents*/Anti-Bacterial Agents*/Anti-Bacterial Agents*/therapeutic use ; Anti-Bacterial Agents*/Anti-Bacterial Agents*/Anti-Bacterial Agents*/pharmacology ; Drug Development*

• Source: Emerging infectious diseases [Emerg Infect Dis] 2024 Nov; Vol. 30 (11), pp. 2227-2230.Publisher: National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC) Country of Publication: United States NLM ID: 9508155

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Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.

• Authors : Bai JPF; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.; Earp JC

Subjects: Drug Development/Drug Development/Drug Development/*statistics & numerical data ; Network Pharmacology/Network Pharmacology/Network Pharmacology/*statistics & numerical data ; United States Food and Drug Administration/United States Food and Drug Administration/United States Food and Drug Administration/*statistics & numerical data

• Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2021 Dec; Vol. 10 (12), pp. 1479-1484. Date of Electronic Publication: 2021 Nov 03.Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations.

• Authors : Lyauk YK; Translational Medicine, Ferring Pharmaceuticals A/S, Copenhagen, Denmark.; Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.

Subjects: Drug Approval* ; Drug Development* ; United States Food and Drug Administration*

• Source: Clinical and translational science [Clin Transl Sci] 2019 Sep; Vol. 12 (5), pp. 481-489. Date of Electronic Publication: 2019 Jun 29.Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print-Electronic Cited Medium: Internet

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Forward or Backward: Lessons Learned from Small Molecule Drugs Approved by FDA from 2012 to 2022.

• Authors : Gu M; State Key Laboratory of Natural Medicines and Jiangsu Key Laboratory of Drug Design and Optimization, China Pharmaceutical University, Nanjing 210009, China.; Department of Medicinal Chemistry, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China.

Subjects: Drug Approval* ; Drug Development*; United States

• Source: Molecules (Basel, Switzerland) [Molecules] 2023 Dec 05; Vol. 28 (24). Date of Electronic Publication: 2023 Dec 05.Publisher: MDPI Country of Publication: Switzerland NLM ID: 100964009 Publication Model: Electronic Cited Medium: Internet ISSN: 1420-3049

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Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.

• Authors : Ye J; Global Statistics and Data Sciences (GSDS), BeiGene, Fulton, MD, USA.; Zhang V

Subjects: Drug Approval* ; Drug Development*; Child

• Source: Journal of biopharmaceutical statistics [J Biopharm Stat] 2023 Nov 02; Vol. 33 (6), pp. 681-695. Date of Electronic Publication: 2023 Feb 07.Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Advice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven.

• Authors : Niazi, Sarfaraz K.¹ (AUTHOR)

• Source: Pharmaceuticals (14248247). Nov2024, Vol. 17 Issue 11, p1424. 14p.

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