Search Results - "Burckart GJ"

A randomized trial of inhaled cyclosporine in lung-transplant recipients.

Authors: Iacono AT Johnson BA Grgurich WF et al.

Source: New England Journal of Medicine. 1/12/2006, Vol. 354 Issue 2, p141-150. 10p.

Evolving landscape of drug development for pediatric rare diseases-from successes to strategies for addressing unmet needs.

Authors: Stern S Zhang Y Pressly M et al.

Source: Journal of pharmaceutical sciences [J Pharm Sci] 2026 Jun 20; Vol. 115 (9), pp. 104401. Date of Electronic Publication: 2026 Jun 20.

Publication Type: Journal Article; Review

Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE

Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.

Authors: Abdel-Rahman SM Gong Y Choi C et al.

Source: Pharmaceutical medicine [Pharmaceut Med] 2026 May; Vol. 40 (3), pp. 225-233. Date of Electronic Publication: 2026 May 10.

Publication Type: Journal Article

Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 101471195 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1993 (Electronic) Linking ISSN: 11782595 NLM ISO Abbreviation: Pharmaceut Med Subsets: MEDLINE

Pediatric Hepatic Impairment Dosing in FDA Approvals Between 2002 and 2024.

Authors: Cassel DA Burckart GJ Sahre MD et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2026 May; Vol. 119 (5), pp. 1257-1264. Date of Electronic Publication: 2025 Jul 24.

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

Pediatric Developmental Drug Toxicity: Description of Juvenile Animal Studies in US FDA Prescribing Information and Assessing the Need for New Approach Methodologies.

Authors: Abulwerdi G Nguyen H Samuels S et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Sep; Vol. 65 (9), pp. 1150-1156. Date of Electronic Publication: 2025 Apr 16.

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

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

Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020.

Authors: Lee CKK Kwon E Green FG et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Aug; Vol. 65 (8), pp. 955-960. Date of Electronic Publication: 2025 Mar 11.

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

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

Physiologically based Pharmacokinetic/Pharmacodynamic Modeling (PBPK/PD) of Famotidine in Pregnancy.

Authors: Liu XI Green DJ van den Anker J et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 May; Vol. 65 (5), pp. 564-574. Date of Electronic Publication: 2025 Jan 10.

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

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

PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.

Authors: Wu F Tsakalozou E Burckart GJ et al.

Source: Pharmaceutical research [Pharm Res] 2025 May; Vol. 42 (5), pp. 847-855. Date of Electronic Publication: 2025 Mar 26.

Publication Type: Journal Article

Journal Info: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE

Effect of Incentivizing Pediatric Studies on the Development of Pediatric-Friendly Formulations.

Authors: Abdel-Rahman SM Burckart GJ

Source: The AAPS journal [AAPS J] 2026 Mar 25; Vol. 28 (3). Date of Electronic Publication: 2026 Mar 25.

Publication Type: 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

PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.

Authors: Burckart GJ Abdel-Rahman S Choi C et al.

Source: The AAPS journal [AAPS J] 2026 Mar 09; Vol. 28 (2). Date of Electronic Publication: 2026 Mar 09.

Publication Type: 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

Anthropometric Exclusions in Pediatric Clinical Trials: Implications for Medication Dosing in Malnourished Children.

Authors: Abdel-Rahman SM Samuels S Cole J et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2026 Mar; Vol. 66 (3), pp. e70120. Date of Electronic Publication: 2025 Oct 13.

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

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

Labetalol Dosing in Pregnancy: PBPK/PD and CYP2C19 Polymorphisms.

Authors: Liu XI Green DJ van den Anker J et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Nov; Vol. 64 (11), pp. 1443-1455. Date of Electronic Publication: 2024 Jul 08.

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

A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015-2022.

Authors: Samuels S Seaton M Abdel-Rahman SM et al.

Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jan; Vol. 60 (1), pp. 153-160. Date of Electronic Publication: 2025 Oct 04.

Publication Type: Journal Article; Review

Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

Access to Pediatric-Friendly Formulations at the Time of Pediatric Labeling and After Marketing.

Authors: Abdel-Rahman SM Avant DA Burckart GJ

Source: Pediatrics [Pediatrics] 2026 Jan 01; Vol. 157 (1).

Publication Type: Journal Article

Journal Info: Publisher: American Academy of Pediatrics Country of Publication: United States NLM ID: 0376422 Publication Model: Print Cited Medium: Internet ISSN: 1098-4275 (Electronic) Linking ISSN: 00314005 NLM ISO Abbreviation: Pediatrics Subsets: MEDLINE

Paediatric developmental safety and the ICH E11A extrapolation of safety.

Authors: Burckart GJ Abdel-Rahman SM Abulwerdi G et al.

Source: British journal of clinical pharmacology [Br J Clin Pharmacol] 2025 Nov 29. Date of Electronic Publication: 2025 Nov 29.

Publication Type: Journal Article

Journal Info: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE

Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Authors: Burckart GJ Abdel-Rahman SM Abulwerdi G et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2025 Nov 19. Date of Electronic Publication: 2025 Nov 19.

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

Optimizing Dosage in Pharmacotherapy-Missing the Forest for the Trees.

Authors: Abdel-Rahman SM Farrell AJ Berry NS et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Sep; Vol. 116 (3), pp. 511-514. Date of Electronic Publication: 2024 Apr 15.

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

Assessment of Dosing Strategies for Pediatric Drug Products.

Authors: Taylor ZL Green FG Hossain N et al.

Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Sep; Vol. 116 (3), pp. 716-723. Date of Electronic Publication: 2024 Mar 17.

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

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

Food-Drug Effects and Pediatric Drug Development Studies Submitted to the US Food and Drug Administration, 2012-2022.

Authors: Tunehag KR George B Samuels S et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Jun; Vol. 64 (6), pp. 697-703. Date of Electronic Publication: 2024 Jan 31.

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