Search Results - "DRUG labeling"

Comparison of Population Pharmacokinetics-Related Information in Drug Labeling Between Japan, the United States, and the European Union.

Authors: Fukuhara K Narukawa M

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Nov; Vol. 65 (11), pp. 1362-1369. Date of Electronic Publication: 2025 May 22.

Publication Type: Journal Article; Comparative Study

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

MeSH Terms: Drug Labeling*/standards , Drug Labeling*/statistics & numerical data , Pharmacokinetics*, Japan ; United States ; European Union ; Humans ; Pharmaceutical Preparations/metabolism

Evaluation of pharmacogenomic information in drug labeling: a case study from Jordan.

Authors: Jarrar Y Hakooz N Ajamieh MA et al.

Source: Personalized medicine [Per Med] 2025 Oct; Vol. 22 (5), pp. 305-311. Date of Electronic Publication: 2025 Jul 15.

Publication Type: Journal Article

Journal Info: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101238549 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-828X (Electronic) Linking ISSN: 17410541 NLM ISO Abbreviation: Per Med Subsets: MEDLINE

MeSH Terms: Drug Labeling*/standards , Drug Labeling*/methods , Pharmacogenetics*/methods, Jordan ; Humans ; United States ; United States Food and Drug Administration ; Hungary

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

Clear front-of-pack labelling information can improve sunscreen reapplication knowledge and intentions: findings from an online experiment.

Authors: Nicholson A Haynes A Brennan E et al.

Source: BMC public health [BMC Public Health] 2025 Oct 29; Vol. 25 (1), pp. 3656. Date of Electronic Publication: 2025 Oct 29.

Publication Type: Journal Article; Randomized Controlled Trial

Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE

MeSH Terms: Sunscreening Agents*/administration & dosage , Health Knowledge, Attitudes, Practice* , Drug Labeling*/methods , Drug Labeling*/standards , Intention* , Product Labeling*/methods, Humans ; Adult ; Female ; Male ; Middle Aged ; Young Adult ; Australia ; New Zealand ; Adolescent ; Internet

A systematic comparison of patient information leaflets from local and multinational pharmaceutical companies: Assessing content quality and completeness.

Authors: Ibrahim Alzarea A Athar Ishaqui A Zeeshan M et al.

Source: PloS one [PLoS One] 2025 Nov 07; Vol. 20 (11), pp. e0335149. Date of Electronic Publication: 2025 Nov 07 (Print Publication: 2025).

Publication Type: Journal Article; Comparative Study

Journal Info: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

MeSH Terms: Drug Industry* , Patient Education as Topic*/standards , Drug Labeling*/standards, Humans ; Cross-Sectional Studies ; Female

Association of Social Determinants of Health and Penicillin Allergy Labels: A Case-Control Study.

Authors: Chow TG Alvarez KS Harms M et al.

Source: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2025 Nov 06; Vol. 81 (4), pp. 702-709.

Publication Type: Journal Article

Journal Info: Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE

MeSH Terms: Penicillins*/adverse effects , Social Determinants of Health*/statistics & numerical data , Drug Hypersensitivity*/epidemiology , Anti-Bacterial Agents*/adverse effects , Drug Labeling*, Humans ; Case-Control Studies ; Male ; Female ; Retrospective Studies ; Adult ; Middle Aged ; Young Adult ; United States/epidemiology

Review of Clinical Pharmacology Information for Peptides Found in US FDA Drug Labeling.

Authors: Naik R Wang J Zhou L et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Nov; Vol. 65 (11), pp. 1370-1380. Date of Electronic Publication: 2025 Jun 04.

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

MeSH Terms: Drug Labeling* , Peptides*/pharmacology , Peptides*/adverse effects , Pharmacology, Clinical*, United States ; United States Food and Drug Administration ; Humans ; Drug Interactions

The Evaluation of Interactions Between Multiple Intrinsic and Extrinsic Factors Reported in Labeling for FDA-Approved Drugs.

Authors: Bailey SL Stern S Dahmane E et al.

Source: Journal of clinical pharmacology [J Clin Pharmacol] 2025 Nov; Vol. 65 (11), pp. 1392-1401. Date of Electronic Publication: 2025 Jun 26.

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

MeSH Terms: Drug Labeling*/statistics & numerical data, Humans ; United States ; United States Food and Drug Administration ; Drug Interactions ; Drug Approval ; Female ; Male ; Pharmacogenetics ; Age Factors ; Pregnancy ; Food-Drug Interactions

Implementation of a proposed algorithm to assess and de-label false penicillin allergy labels in the community.

Authors: Lim A Khumra S Mitri EA et al.

Source: Infection, disease & health [Infect Dis Health] 2025 Nov; Vol. 30 (4), pp. 316-321. Date of Electronic Publication: 2025 May 07.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 101689703 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2468-0869 (Electronic) Linking ISSN: 24680451 NLM ISO Abbreviation: Infect Dis Health Subsets: MEDLINE

MeSH Terms: Algorithms* , Penicillins*/adverse effects , Drug Hypersensitivity*/prevention & control , Drug Hypersensitivity*/diagnosis , Anti-Bacterial Agents*/adverse effects , Drug Labeling*, Humans ; Victoria ; Female ; Male ; Middle Aged ; Adult ; Aged

A systematic analysis of package insert information referencing race and ethnicity for 100 medications commonly used in critically ill patients.

Authors: Erstad BL Agundez J Nishikawa N et al.

Source: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2025 Oct 23; Vol. 82 (21), pp. e892-e899.

Publication Type: Journal Article

Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN: 1535-2900 (Electronic) Linking ISSN: 10792082 NLM ISO Abbreviation: Am J Health Syst Pharm Subsets: MEDLINE

MeSH Terms: Drug Labeling*/standards , Critical Illness* , Racial Groups* , Ethnicity* , Terminology as Topic*, Humans ; United States ; United States Food and Drug Administration ; Pharmaceutical Preparations ; Intensive Care Units

Quality and readability of drug fact sheets for FDA-approved and emergency use authorised drug products for COVID-19 treatment: an observational study.

Authors: Pranic SM Karačić Zanetti J Pulumati A et al.

Source: BMJ open [BMJ Open] 2025 Oct 15; Vol. 15 (10), pp. e101030. Date of Electronic Publication: 2025 Oct 15.

Publication Type: Journal Article; Observational Study

Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE

MeSH Terms: COVID-19 Drug Treatment* , Comprehension* , Drug Labeling*/standards , Antiviral Agents*/therapeutic use, Humans ; United States ; Cross-Sectional Studies ; United States Food and Drug Administration ; SARS-CoV-2 ; Drug Approval

A systematic analysis of medicine information pertaining to race and ethnicity terms for 100 top selling medicines in the USA.

Authors: Alvarez NA DeBano W Agundez J et al.

Source: The International journal of pharmacy practice [Int J Pharm Pract] 2025 Oct 03; Vol. 33 (5), pp. 508-514.

Publication Type: Journal Article

Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 9204243 Publication Model: Print Cited Medium: Internet ISSN: 2042-7174 (Electronic) Linking ISSN: 09617671 NLM ISO Abbreviation: Int J Pharm Pract Subsets: MEDLINE

MeSH Terms: Terminology as Topic* , Ethnicity* , Racial Groups* , Drug Labeling*/standards, United States ; Humans ; United States Food and Drug Administration ; Pharmaceutical Preparations/economics

A "Pheraplex" Capsule Labeled as Desoxymethyltestosterone From the Market Turned Out to Be 17,17-Dimethyl-18-nor-5α-androst-13-en-3β-ol.

Authors: Zhu S Wang S Liu X et al.

Source: Drug testing and analysis [Drug Test Anal] 2025 Oct; Vol. 17 (10), pp. 2032-2035. Date of Electronic Publication: 2025 May 23.

Publication Type: Journal Article

Journal Info: Publisher: John Wiley & Sons Country of Publication: England NLM ID: 101483449 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1942-7611 (Electronic) Linking ISSN: 19427603 NLM ISO Abbreviation: Drug Test Anal Subsets: MEDLINE

MeSH Terms: Drug Labeling*, Capsules ; Doping in Sports ; Gas Chromatography-Mass Spectrometry/methods ; Substance Abuse Detection/methods ; Tandem Mass Spectrometry/methods ; Androstenols

The Pragmatic Removal of Penicillin Allergy Electronic Health Record Labels (PROPEL) Trial: A Randomized Clinical Trial.

Authors: Stone CA Jr Prigmore HL McCoy AB et al.

Corporate Authors: Stone CA Jr Prigmore HL McCoy AB et al.

Source: The journal of allergy and clinical immunology. In practice [J Allergy Clin Immunol Pract] 2025 Oct; Vol. 13 (10), pp. 2747-2755. Date of Electronic Publication: 2025 Jul 16.

Publication Type: Journal Article; Randomized Controlled Trial; Pragmatic Clinical Trial

Journal Info: Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101597220 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-2201 (Electronic) NLM ISO Abbreviation: J Allergy Clin Immunol Pract Subsets: MEDLINE

MeSH Terms: Drug Hypersensitivity*/diagnosis , Penicillins*/adverse effects , Electronic Health Records* , Anti-Bacterial Agents*/adverse effects , Drug Labeling*, Humans ; Female ; Male ; Middle Aged ; Aged ; Adult ; Amoxicillin ; Antimicrobial Stewardship

Penicillin Allergy De-Labeling in Older Adults and Long-Term Care Residents: A Clinical Review.

Authors: Shah RJ Smith LR Norton DT et al.

Source: Journal of the American Geriatrics Society [J Am Geriatr Soc] 2025 Oct; Vol. 73 (10), pp. 3234-3244. Date of Electronic Publication: 2025 Jul 05.

Publication Type: Journal Article; Review

Journal Info: Publisher: Blackwell Science Country of Publication: United States NLM ID: 7503062 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-5415 (Electronic) Linking ISSN: 00028614 NLM ISO Abbreviation: J Am Geriatr Soc Subsets: MEDLINE

MeSH Terms: Drug Hypersensitivity*/epidemiology , Drug Hypersensitivity*/diagnosis , Drug Hypersensitivity*/etiology , Penicillins*/adverse effects , Long-Term Care* , Anti-Bacterial Agents*/adverse effects , Drug Labeling*, Humans ; Aged ; Prevalence ; Aged, 80 and over

Prevalence and risk assessment of drug allergies in hospitalized patients: Potential for allergy delabeling.

Authors: Nacsa R Matuz M Papfalvi E et al.

Source: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2025 Oct 01; Vol. 213, pp. 107240. Date of Electronic Publication: 2025 Aug 21.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Science B.V Country of Publication: Netherlands NLM ID: 9317982 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0720 (Electronic) Linking ISSN: 09280987 NLM ISO Abbreviation: Eur J Pharm Sci Subsets: MEDLINE

MeSH Terms: Drug Hypersensitivity*/epidemiology , Drug Labeling*, Humans ; Prevalence ; Male ; Female ; Middle Aged ; Risk Assessment ; Cross-Sectional Studies ; Aged ; Adult ; Hungary/epidemiology ; Hospitalization ; Young Adult ; Inpatients ; Aged, 80 and over ; Adolescent

Japanese medicinal drug labeling for use in the clinical setting as informed by pharmacogenomic data on cytochrome P450 enzymes obtained from in silico studies.

Authors: Tanaka Y Shimizu M Saito Y et al.

Source: Drug metabolism and pharmacokinetics [Drug Metab Pharmacokinet] 2025 Oct; Vol. 64, pp. 101496. Date of Electronic Publication: 2025 May 29.

Publication Type: Journal Article; Review

Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 101164773 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1880-0920 (Electronic) Linking ISSN: 13474367 NLM ISO Abbreviation: Drug Metab Pharmacokinet Subsets: MEDLINE

MeSH Terms: Cytochrome P-450 Enzyme System*/genetics , Cytochrome P-450 Enzyme System*/metabolism , Drug Labeling* , Pharmacogenetics*/methods, Humans ; Computer Simulation ; Drug Interactions ; Japan ; Pharmaceutical Preparations/metabolism ; East Asian People

Strengthening the Food and Drug Administration Office of Clinical Pharmacology's Labeling Authority.

Authors: Ratain MJ Strohbehn GW

Source: Clinical and translational science [Clin Transl Sci] 2025 Sep; Vol. 18 (9), pp. e70337.

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

MeSH Terms: United States Food and Drug Administration*/legislation & jurisprudence , Drug Labeling*/standards , Drug Labeling*/legislation & jurisprudence , Pharmacology, Clinical*/standards , Pharmacology, Clinical*/legislation & jurisprudence, United States ; Humans ; Dose-Response Relationship, Drug

Pediatric Exclusivity-Associated Revenues and Labeling Changes, 2013-2023.

Authors: Liu ITT Raymakers AJN Sarpatwari A et al.

Source: The Journal of pediatrics [J Pediatr] 2025 Sep; Vol. 284, pp. 114660. Date of Electronic Publication: 2025 May 17.

Publication Type: Journal Article

Journal Info: Publisher: Mosby Country of Publication: United States NLM ID: 0375410 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6833 (Electronic) Linking ISSN: 00223476 NLM ISO Abbreviation: J Pediatr Subsets: MEDLINE

MeSH Terms: Drug Labeling*/legislation & jurisprudence , Drug Labeling*/economics , Drugs, Generic*/economics , Drug Approval*/economics , Drug Approval*/legislation & jurisprudence , Pediatrics*/legislation & jurisprudence, Humans ; Retrospective Studies ; United States ; Child ; United States Food and Drug Administration ; Clinical Trials as Topic

Characterization of drug-related oral and dental adverse events: Literature vs drug labeling.

Authors: Billings M Lee H Mendoza JL et al.

Source: Journal of the American Dental Association (1939) [J Am Dent Assoc] 2025 Aug; Vol. 156 (8), pp. 638-648.e6.

Publication Type: Journal Article; Systematic Review

Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 7503060 Publication Model: Print Cited Medium: Internet ISSN: 1943-4723 (Electronic) Linking ISSN: 00028177 NLM ISO Abbreviation: J Am Dent Assoc Subsets: MEDLINE

MeSH Terms: Drug Labeling* , Drug-Related Side Effects and Adverse Reactions* , Mouth Diseases*/chemically induced, Humans ; United States