Search Results - "Fletcher EP"

Informing Dose for Pediatric Rare Diseases-A Survey of Recent Orphan Drugs Approvals.

Authors: Fletcher EP Kim C Mei H et al.

Source: Clinical and translational science [Clin Transl Sci] 2026 Feb; Vol. 19 (2), pp. e70503.

Publication Type: Journal Article

Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment: Role and Opportunities.

Authors: Ramamoorthy A Guinn D Fletcher EP et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Sep; Vol. 65 (9), pp. 1176-1180. Date of Electronic Publication: 2025 Apr 16.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE; In Process

Drug Administration via Enteral Feeding Tubes: A Landscape Analysis of Information in Drug Product Labeling.

Authors: Samuels S Denisenko D Abdel-Rahman S et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2026 Feb; Vol. 66 (2), pp. e70160.

Publication Type: Journal Article; Review

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

Population Pharmacokinetics (PopPK) Support for Pediatric Dosing of Biological Products.

Authors: Eales B Helal NA Vattelana O et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Dec; Vol. 64 (12), pp. 1594-1605. Date of Electronic Publication: 2024 Aug 16.

Publication Type: Journal Article; Review

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

Evaluation and Mitigation of Time-Dependent Confounding Effects in Conventional Exposure-Response Analyses for Oncology Drugs.

Authors: Yin X Xiong Y Bi Y et al.

Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2025 Dec; Vol. 14 (12), pp. 2118-2127. Date of Electronic Publication: 2025 Sep 25.

Publication Type: Journal Article; Research Support, U.S. Gov't, Non-P.H.S.

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE

Application of Lactation Physiologically Based Pharmacokinetic Modeling to Predict Milk Exposure of Passively Diffused Drugs.

Authors: Kayesh R Pressly M Guinn D et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Dec; Vol. 65 (12), pp. 1637-1649. Date of Electronic Publication: 2025 Aug 25.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

On placental and lactational transfer of IgG-based therapeutic proteins - Current understanding and knowledge gaps from a clinical pharmacology perspective.

Authors: Guinn D Kratz K Baisden K et al.

Source: Clinical and translational science [Clin Transl Sci] 2024 Oct; Vol. 17 (10), pp. e70049.

Publication Type: Journal Article; Review

Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities.

Authors: Vaidyanathan J Fletcher EP Ramamoorthy A et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Nov; Vol. 63 Suppl 2, pp. S10-S17.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

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

Authors: Abulwerdi GA Ramamoorthy A Bashaw E et al.

Source: Clinical and translational science [Clin Transl Sci] 2023 Oct; Vol. 16 (10), pp. 2046-2057. Date of Electronic Publication: 2023 Aug 18.

Publication Type: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.

Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE

Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy.

Authors: Leong R Grimstein M DeMaria P et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Jun; Vol. 63 Suppl 1, pp. S170-S175.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary.

Authors: Guinn D Sahin L Fletcher EP et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Jun; Vol. 63 Suppl 1, pp. S7-S17.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.

Authors: Pressly MA Schmidt S Guinn D et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Jun; Vol. 63 Suppl 1, pp. S106-S116.

Publication Type: Journal Article; Research Support, U.S. Gov't, P.H.S.

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.

Authors: Fletcher EP Sahre M Hon YY et al.

Source: The AAPS journal [AAPS J] 2023 May 26; Vol. 25 (4), pp. 54. Date of Electronic Publication: 2023 May 26.

Publication Type: Review; Journal Article

Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.

Authors: Massaro AN Fletcher EP Madabushi R et al.

Source: The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG [J Pediatr Pharmacol Ther] 2025 Feb; Vol. 30 (1), pp. 8-16. Date of Electronic Publication: 2025 Feb 10.

Publication Type: Journal Article

Journal Info: Publisher: Pediatric Pharmacology Advocacy Group, Inc Country of Publication: United States NLM ID: 101089851 Publication Model: Print-Electronic Cited Medium: Print ISSN: 1551-6776 (Print) Linking ISSN: 15516776 NLM ISO Abbreviation: J Pediatr Pharmacol Ther Subsets: PubMed not MEDLINE

Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective.

Authors: Guinn D Pressly MA Liu Z et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Mar; Vol. 63 (3), pp. 273-276. Date of Electronic Publication: 2022 Nov 23.

Publication Type: Journal Article; Research Support, U.S. Gov't, P.H.S.

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

The Importance of Clinical Research in Pregnant Women to Inform Prescription Drug Labeling.

Authors: Dinatale M Roca C Sahin L et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2020 Dec; Vol. 60 Suppl 2, pp. S18-S25.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE

The RACE to Develop New Targeted Therapies for Children With CNS Tumors.

Authors: Fletcher EP Burckart GJ Robinson GW et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2020 Sep; Vol. 108 (3), pp. 434-436. Date of Electronic Publication: 2020 Jul 07.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics.

Authors: Yang X Grimstein M Pressly M et al.

Source: Pharmaceutics [Pharmaceutics] 2023 Dec 04; Vol. 15 (12). Date of Electronic Publication: 2023 Dec 04.

Publication Type: Journal Article

Journal Info: Publisher: MDPI Country of Publication: Switzerland NLM ID: 101534003 Publication Model: Electronic Cited Medium: Print ISSN: 1999-4923 (Print) Linking ISSN: 19994923 NLM ISO Abbreviation: Pharmaceutics Subsets: PubMed not MEDLINE

Need for Representation of Pediatric Patients with Obesity in Clinical Trials.

Authors: Samuels S Vaidyanathan J Fletcher EP et al.

Source: Children (Basel, Switzerland) [Children (Basel)] 2023 Sep 30; Vol. 10 (10). Date of Electronic Publication: 2023 Sep 30.

Publication Type: Journal Article

Journal Info: Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101648936 Publication Model: Electronic Cited Medium: Print ISSN: 2227-9067 (Print) Linking ISSN: 22279067 NLM ISO Abbreviation: Children (Basel) Subsets: PubMed not MEDLINE

Update on Therapeutic Protein-Drug Interaction: Information in Labeling.

Authors: Jing X Ji P Schrieber SJ et al.

Source: Clinical pharmacokinetics [Clin Pharmacokinet] 2020 Jan; Vol. 59 (1), pp. 25-36.

Publication Type: Journal Article; Review

Journal Info: Publisher: Adis, part of Springer Science+Business Media Country of Publication: Switzerland NLM ID: 7606849 Publication Model: Print Cited Medium: Internet ISSN: 1179-1926 (Electronic) Linking ISSN: 03125963 NLM ISO Abbreviation: Clin Pharmacokinet Subsets: MEDLINE