Search Results - "DRUG administration"

Mass Administration of Azithromycin to Infants in Mali to Reduce Mortality.

Authors: Haidara FC Adubra L Abdou M et al.

Source: The New England journal of medicine [N Engl J Med] 2025 Oct 16; Vol. 393 (15), pp. 1498-1508.

Publication Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial

Journal Info: Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE

MeSH Terms: Anti-Bacterial Agents*/administration & dosage , Anti-Bacterial Agents*/adverse effects , Azithromycin*/administration & dosage , Azithromycin*/adverse effects , Infant Mortality* , Mass Drug Administration*/adverse effects , Mass Drug Administration*/methods , Mass Drug Administration*/statistics & numerical data , Child Mortality*, Child, Preschool ; Female ; Humans ; Infant ; Male ; Intention to Treat Analysis ; Mali/epidemiology ; Drug Administration Schedule ; Double-Blind Method ; Follow-Up Studies ; Treatment Outcome

Factors associated with low coverage in mass drug administration for schistosomiasis in mobile populations in mali: a cross-sectional study.

Authors: Sangare M Coulibaly YI Diabate AF et al.

Source: BMC infectious diseases [BMC Infect Dis] 2025 Oct 07; Vol. 25 (1), pp. 1240. Date of Electronic Publication: 2025 Oct 07.

Publication Type: Journal Article

Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE

MeSH Terms: Mass Drug Administration*/statistics & numerical data , Schistosomiasis*/drug therapy , Schistosomiasis*/epidemiology , Schistosomiasis*/prevention & control , Transients and Migrants*/statistics & numerical data, Humans ; Cross-Sectional Studies ; Mali/epidemiology ; Female ; Male ; Adult ; Middle Aged ; Young Adult ; Adolescent ; Neglected Diseases/drug therapy ; Neglected Diseases/epidemiology

FDA Boxed Warnings: Should Package Inserts Include Levels of Evidence?

Authors: Leung A Bhutani T Brownstone N et al.

Source: Journal of drugs in dermatology : JDD [J Drugs Dermatol] 2025 Dec 01; Vol. 24 (12), pp. e67-e69.

Publication Type: Journal Article

Journal Info: Publisher: Physicians Continuing Education Corporation Country of Publication: United States NLM ID: 101160020 Publication Model: Print Cited Medium: Internet ISSN: 1545-9616 (Print) Linking ISSN: 15459616 NLM ISO Abbreviation: J Drugs Dermatol Subsets: MEDLINE

MeSH Terms: Drug Labeling*/standards , Drug Labeling*/legislation & jurisprudence , United States Food and Drug Administration*/standards , Dermatologic Agents*/adverse effects , Dermatologic Agents*/therapeutic use, United States ; Humans ; Evidence-Based Medicine ; Skin Diseases/drug therapy

Exploring drug coverage variability within districts: A CES approach to investigate treatment gaps in Mozambique's schistosomiasis program.

Authors: Mathewson JD Tomas SR Nshala A et al.

Source: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2025 Dec 01; Vol. 19 (12), pp. e0013751. Date of Electronic Publication: 2025 Dec 01 (Print Publication: 2025).

Publication Type: Journal Article

Journal Info: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE

MeSH Terms: Mass Drug Administration*/statistics & numerical data , Schistosomiasis*/drug therapy , Schistosomiasis*/epidemiology , Schistosomiasis*/prevention & control , Praziquantel*/therapeutic use , Praziquantel*/administration & dosage , Anthelmintics*/therapeutic use, Mozambique/epidemiology ; Humans ; Female ; Male ; Adult ; Adolescent ; Surveys and Questionnaires ; Young Adult ; Child ; Middle Aged

Safety evaluation of deucravacitinib: a real-world analysis based on the FDA adverse event reporting system database.

Authors: Tan H Chen X Ou X et al.

Source: International journal of clinical pharmacy [Int J Clin Pharm] 2025 Dec; Vol. 47 (6), pp. 1821-1829. Date of Electronic Publication: 2025 Aug 09.

Publication Type: Journal Article

Journal Info: Publisher: Springer Country of Publication: Netherlands NLM ID: 101554912 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2210-7711 (Electronic) NLM ISO Abbreviation: Int J Clin Pharm Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration* , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Databases, Factual*/trends , Product Surveillance, Postmarketing* , Protein Kinase Inhibitors*/adverse effects, Humans ; United States/epidemiology ; Adult ; Male ; Female ; Middle Aged

Drug-related retinal detachment pharmacovigilance signals in the real world: evidence from the FDA Adverse Event Reporting System.

Authors: Chen XD Xiao KH Wu SN et al.

Source: Eye (London, England) [Eye (Lond)] 2025 Dec; Vol. 39 (18), pp. 3284-3293. Date of Electronic Publication: 2025 Oct 10.

Publication Type: Journal Article

Journal Info: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 8703986 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1476-5454 (Electronic) Linking ISSN: 0950222X NLM ISO Abbreviation: Eye (Lond) Subsets: MEDLINE

MeSH Terms: Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Retinal Detachment*/chemically induced , Retinal Detachment*/epidemiology , Pharmacovigilance* , United States Food and Drug Administration*/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions*/epidemiology, Humans ; United States/epidemiology ; Male ; Female ; Middle Aged ; Adult ; Aged ; Young Adult ; Adolescent

Comparative evaluation of pregnancy-related adverse events associated with proton pump inhibitors using the FDA adverse event reporting system database.

Authors: Dong W Ran Y Cai Y et al.

Source: International journal of clinical pharmacy [Int J Clin Pharm] 2025 Dec; Vol. 47 (6), pp. 2051-2060. Date of Electronic Publication: 2025 Oct 23.

Publication Type: Journal Article; Comparative Study

Journal Info: Publisher: Springer Country of Publication: Netherlands NLM ID: 101554912 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2210-7711 (Electronic) NLM ISO Abbreviation: Int J Clin Pharm Subsets: MEDLINE

MeSH Terms: Proton Pump Inhibitors*/adverse effects , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , United States Food and Drug Administration* , Databases, Factual* , Pregnancy Complications*/epidemiology , Pregnancy Complications*/chemically induced , Pregnancy Complications*/diagnosis , Drug-Related Side Effects and Adverse Reactions*/epidemiology , Drug-Related Side Effects and Adverse Reactions*/diagnosis, Pregnancy ; Female ; Humans ; United States/epidemiology ; Adult

Pharmacovigilance assessment of drug-induced aplastic anemia: analysis of the FDA adverse event reporting system.

Authors: Zhang F Wang P Liu X et al.

Source: International journal of clinical pharmacy [Int J Clin Pharm] 2025 Dec; Vol. 47 (6), pp. 1967-1978. Date of Electronic Publication: 2025 Sep 29.

Publication Type: Journal Article

Journal Info: Publisher: Springer Country of Publication: Netherlands NLM ID: 101554912 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2210-7711 (Electronic) NLM ISO Abbreviation: Int J Clin Pharm Subsets: MEDLINE

MeSH Terms: Pharmacovigilance* , Anemia, Aplastic*/chemically induced , Anemia, Aplastic*/epidemiology , Anemia, Aplastic*/diagnosis , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , United States Food and Drug Administration* , Drug-Related Side Effects and Adverse Reactions*/epidemiology , Drug-Related Side Effects and Adverse Reactions*/diagnosis, Humans ; Male ; Female ; United States/epidemiology ; Retrospective Studies ; Middle Aged ; Adult ; Aged ; Young Adult ; Adolescent ; Child ; Risk Factors ; Child, Preschool

Argatroban-Associated Adverse Events: An Analysis Based on FDA Adverse Event Reporting System (FAERS).

Authors: Ren C Guo G Wang Y et al.

Source: Cardiovascular toxicology [Cardiovasc Toxicol] 2025 Dec; Vol. 25 (12), pp. 1927-1937. Date of Electronic Publication: 2025 Oct 17.

Publication Type: Journal Article

Journal Info: Publisher: Humana Press Country of Publication: United States NLM ID: 101135818 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-0259 (Electronic) Linking ISSN: 15307905 NLM ISO Abbreviation: Cardiovasc Toxicol Subsets: MEDLINE

MeSH Terms: Adverse Drug Reaction Reporting Systems* , Pipecolic Acids*/adverse effects , United States Food and Drug Administration* , Platelet Aggregation Inhibitors*/adverse effects , Antithrombins*/adverse effects, Humans ; Sulfonamides ; Arginine/analogs & derivatives ; Male ; Female ; United States/epidemiology ; Pharmacovigilance ; Databases, Factual ; Data Mining ; Middle Aged ; Aged ; Adult ; Risk Assessment ; Risk Factors ; Time Factors

Primary suspect drugs of cataracts in pediatric patients: FDA adverse events reporting database analysis.

Authors: Ali A Dockery PW Downes DG et al.

Source: Journal of cataract and refractive surgery [J Cataract Refract Surg] 2025 Dec 01; Vol. 51 (12), pp. 1044-1050.

Publication Type: Journal Article; Observational Study

Journal Info: Publisher: Wolters Kluwer on behalf of ASCRS and ESCRS Country of Publication: United States NLM ID: 8604171 Publication Model: Print Cited Medium: Internet ISSN: 1873-4502 (Electronic) Linking ISSN: 08863350 NLM ISO Abbreviation: J Cataract Refract Surg Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration*/statistics & numerical data , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Cataract*/chemically induced , Pharmacovigilance* , Drug-Related Side Effects and Adverse Reactions*, Humans ; Child ; United States/epidemiology ; Retrospective Studies ; Male ; Female ; Adolescent ; Databases, Factual ; Child, Preschool ; Infant

Investigating drug-induced optic nerve hypoplasia and septo-optic dysplasia from the FDA adverse events database.

Authors: Ali A Azhari JO Gise R et al.

Source: Canadian journal of ophthalmology. Journal canadien d'ophtalmologie [Can J Ophthalmol] 2025 Dec; Vol. 60 (6), pp. e851-e857. Date of Electronic Publication: 2025 Jun 06.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 0045312 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1715-3360 (Electronic) Linking ISSN: 00084182 NLM ISO Abbreviation: Can J Ophthalmol Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration*/statistics & numerical data , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Septo-Optic Dysplasia*/chemically induced , Septo-Optic Dysplasia*/epidemiology , Septo-Optic Dysplasia*/diagnosis , Optic Nerve Hypoplasia*/chemically induced , Optic Nerve Hypoplasia*/epidemiology , Optic Nerve Hypoplasia*/diagnosis , Drug-Related Side Effects and Adverse Reactions*/epidemiology, Humans ; Female ; Retrospective Studies ; Male ; United States/epidemiology ; Databases, Factual ; Adult ; Pharmacovigilance ; Pregnancy ; Young Adult ; Child ; Infant ; Adolescent ; Child, Preschool

Real-world safety profile of mitomycin: signal detection and time-to-onset analysis from FDA adverse event reporting system and VigiAccess databases.

Authors: Hao Z Yu L

Source: International journal of clinical pharmacy [Int J Clin Pharm] 2025 Dec; Vol. 47 (6), pp. 1894-1907. Date of Electronic Publication: 2025 Aug 28.

Publication Type: Journal Article

Journal Info: Publisher: Springer Country of Publication: Netherlands NLM ID: 101554912 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2210-7711 (Electronic) NLM ISO Abbreviation: Int J Clin Pharm Subsets: MEDLINE

MeSH Terms: Mitomycin*/adverse effects , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Adverse Drug Reaction Reporting Systems*/trends , United States Food and Drug Administration* , Pharmacovigilance* , Databases, Factual*/trends , Antibiotics, Antineoplastic*/adverse effects, Humans ; United States/epidemiology ; Male ; Female ; Middle Aged ; Aged ; Time Factors ; Adult

Adverse events of trabecular micro-bypass minimally invasive glaucoma surgery devices: a five-year analysis from the FDA MAUDE database.

Authors: Hawas Y Ghazou A Gerges MW et al.

Source: International ophthalmology [Int Ophthalmol] 2025 Nov 18; Vol. 45 (1), pp. 493. Date of Electronic Publication: 2025 Nov 18.

Publication Type: Journal Article

Journal Info: Publisher: Kluwer Country of Publication: Netherlands NLM ID: 7904294 Publication Model: Electronic Cited Medium: Internet ISSN: 1573-2630 (Electronic) Linking ISSN: 01655701 NLM ISO Abbreviation: Int Ophthalmol Subsets: MEDLINE

MeSH Terms: Minimally Invasive Surgical Procedures*/adverse effects , Minimally Invasive Surgical Procedures*/instrumentation , United States Food and Drug Administration* , Glaucoma Drainage Implants*/adverse effects , Intraocular Pressure*/physiology , Glaucoma, Open-Angle*/surgery , Glaucoma, Open-Angle*/physiopathology , Postoperative Complications*/epidemiology , Trabecular Meshwork*/surgery, Humans ; Retrospective Studies ; United States ; Databases, Factual ; Male ; Female ; Middle Aged ; Aged ; Follow-Up Studies ; Glaucoma/surgery ; Time Factors

Beyond business as usual for lymphatic filariasis mass drug administration in hotspot districts.

Authors: de Souza DK Sumboh JG Laryea NA et al.

Source: International health [Int Health] 2025 Nov 04; Vol. 17 (6), pp. 960-967.

Publication Type: Journal Article

Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 101517095 Publication Model: Print Cited Medium: Internet ISSN: 1876-3405 (Electronic) Linking ISSN: 18763405 NLM ISO Abbreviation: Int Health Subsets: MEDLINE

MeSH Terms: Elephantiasis, Filarial*/drug therapy , Elephantiasis, Filarial*/epidemiology , Elephantiasis, Filarial*/diagnosis , Mass Drug Administration*/methods , Filaricides*/therapeutic use , Filaricides*/administration & dosage , Patient Acceptance of Health Care*/statistics & numerical data, Humans ; Male ; Female ; Adult ; Ghana/epidemiology ; Middle Aged ; Young Adult ; Adolescent ; Prevalence

Validation of the US Food and Drug Administration's COVID-19 Disease Severity Categorization for Use in Real-World Data.

Authors: Perez-Vilar S Hua W Kwist A et al.

Source: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2025 Nov; Vol. 34 (11), pp. e70252.

Publication Type: Journal Article; Validation Study

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print Cited Medium: Internet ISSN: 1099-1557 (Electronic) Linking ISSN: 10538569 NLM ISO Abbreviation: Pharmacoepidemiol Drug Saf Subsets: MEDLINE

MeSH Terms: COVID-19*/diagnosis , COVID-19*/classification , COVID-19*/epidemiology , Severity of Illness Index* , United States Food and Drug Administration*, Humans ; United States/epidemiology ; Aged ; Female ; Male ; Aged, 80 and over ; Pilot Projects ; International Classification of Diseases ; Medicare/statistics & numerical data ; Algorithms ; Middle Aged

Distinguishing between Rigor and Transparency in FDA Marketing Authorization of AI-enabled Medical Devices.

Authors: Diab AR Lotter W

Source: Radiology. Artificial intelligence [Radiol Artif Intell] 2025 Nov; Vol. 7 (6), pp. e250369.

Publication Type: Journal Article; Review

Journal Info: Publisher: Radiological Society of North America, Inc Country of Publication: United States NLM ID: 101746556 Publication Model: Print Cited Medium: Internet ISSN: 2638-6100 (Electronic) Linking ISSN: 26386100 NLM ISO Abbreviation: Radiol Artif Intell Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration* , Artificial Intelligence* , Device Approval*/legislation & jurisprudence , Equipment and Supplies*/standards, United States ; Humans

Commentary on FDA's shift from animal testing and implications for drug attrition - The time to act is now.

Authors: von Keutz E; Independent Consultant, Formerly Head of Translational Sciences, Bayer Pharmaceuticals, Germany. Electronic address: eckhard.vonkeutz@t-online.de.

Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2025 Nov; Vol. 162, pp. 105896. Date of Electronic Publication: 2025 Jun 25.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE

MeSH Terms: United States Food and Drug Administration*/legislation & jurisprudence , Animal Testing Alternatives*/legislation & jurisprudence , Animal Testing Alternatives*/methods , Drugs, Investigational*, United States ; Humans ; Animals ; Chemical and Drug Induced Liver Injury/etiology ; Drug Evaluation, Preclinical/methods ; Drug Approval

FocaL mass drug administration for Plasmodium vivax malaria elimination (FLAME): study protocol for an open-label cluster randomized controlled trial in Peru.

Authors: Fine SR Soto Calle V Altamirano Quiroz A et al.

Source: Trials [Trials] 2025 Oct 14; Vol. 26 (1), pp. 408. Date of Electronic Publication: 2025 Oct 14.

Publication Type: Journal Article; Clinical Trial Protocol

Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

MeSH Terms: Antimalarials*/administration & dosage , Antimalarials*/adverse effects , Antimalarials*/economics , Chloroquine*/administration & dosage , Chloroquine*/adverse effects , Chloroquine*/economics , Malaria, Vivax*/diagnosis , Malaria, Vivax*/drug therapy , Malaria, Vivax*/parasitology , Malaria, Vivax*/prevention & control , Mass Drug Administration* , Plasmodium vivax*/drug effects , Plasmodium vivax*/pathogenicity, Humans ; Clinical Protocols ; Disease Eradication/methods ; Drug Therapy, Combination ; Peru/epidemiology ; Primaquine/administration & dosage ; Primaquine/adverse effects ; Randomized Controlled Trials as Topic ; Time Factors ; Treatment Outcome ; Aminoquinolines

Lessons from piloting and scaling a real-time DHIS2 based treatment reporting tool for mass drug administration in Nigeria.

Authors: Imhansoloeva M Nwosu C Osinoiki O et al.

Source: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2025 Oct 10; Vol. 19 (10), pp. e0013601. Date of Electronic Publication: 2025 Oct 10 (Print Publication: 2025).

Publication Type: Journal Article

Journal Info: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE

MeSH Terms: Mass Drug Administration*/methods , Neglected Diseases*/drug therapy , Neglected Diseases*/prevention & control , Neglected Diseases*/epidemiology, Nigeria/epidemiology ; Humans ; Pilot Projects

Physiologically Based Pharmacokinetic Modeling and Simulation in Regulatory Review: US FDA CBER Experience and Perspectives.

Authors: Tegenge MA Yogurtcu ON Belov AA et al.

Source: The AAPS journal [AAPS J] 2025 Oct 09; Vol. 27 (6), pp. 157. Date of Electronic Publication: 2025 Oct 09.

Publication Type: Journal Article; Review

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

MeSH Terms: United States Food and Drug Administration* , Models, Biological* , Computer Simulation* , Biological Products*/pharmacokinetics , Biological Products*/administration & dosage , Drug Development*/methods , Drug Development*/legislation & jurisprudence , Pharmacokinetics*, Humans ; United States ; Genetic Therapy/methods