Suchergebnisse - "DRUG registration"

Analysis and insights into the changes of traditional Chinese medicine review and approval from 2020 to 2024.

Autoren: Li, Wenli Sun, Qian Ding, Wenxia

Quelle: Asian Journal of Traditional Medicines. Aug2025, Vol. 20 Issue 4, p181-194. 14p.

Schlagwörter: *CHINESE medicine, *DRUG registration, *RESEARCH & development projects, *DRUGS, *EVALUATION methodology, *EMPIRICAL research

Geografische Kategorien: CHINA

抗肿瘤药物Ⅰ期临床试验质量管理要点.

Alternate Title: Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs.

Autoren: 龚莉 廖斌 沈杰 et al.

Quelle: Cancer Research on Prevention & Treatment. May2025, Vol. 52 Issue 5, p347-354. 8p.

Schlagwörter: *DRUG registration, *DRUG development, *QUALITY control, *JUDGMENT (Psychology), *STANDARD operating procedure

Establishment of RWS guidance reflecting contributions of China to regulatory science.

Autoren: Wang, Jun Chen, Jie Zhao, Jun et al.

Quelle: Journal of Biopharmaceutical Statistics. Oct2024, Vol. 34 Issue 6, p864-872. 9p.

Schlagwörter: *DRUG registration, CHINESE medicine, DRUG development, MEDICAL supplies, RARE diseases

Drug regulatory affairs under focus: Knowledge and perceptions among pharmacists and pharmacy students.

Autoren: Ayyash, Manal A. Nassar, Razan I. Al-Muhtaseb, Raghad et al.

Quelle: PLoS ONE. 3/27/2025, Vol. 20 Issue 3, p1-15. 15p.

Schlagwörter: *SOCIAL media, *DRUG registration, *PHARMACY students, *PHARMACISTS' attitudes, *DRUG efficacy

Patch Test Preparations: Basis and State-of-the-Art Modern Diagnostic Tools for Contact Allergy.

Autoren: Zimmer, Julia Neimanis, Sonja Schmidt, Sandra et al.

Quelle: Journal of Clinical Medicine; Nov2025, Vol. 14 Issue 21, p7521, 13p

Schlagwörter: QUALITY assurance, REGULATORY compliance, EVALUATION methodology, DRUG registration, CONTACT dermatitis, ALLERGIES, DIAGNOSIS

Firma/Körperschaft: EUROPEAN Commission, EUROPEAN Union

Trends in and Determinants of Approval Lag for Anticancer Drugs in Japan and the US: Role of Multi‐Regional Trials and Concurrent Approvals.

Autoren: Kanno, Hitoshi Matsuyama, Kotone

Quelle: CTS: Clinical & Translational Science; Oct2025, Vol. 18 Issue 10, p1-8, 8p

Schlagwörter: DRUG approval, CLINICAL trials, PHARMACEUTICAL policy, DRUG registration, ANTINEOPLASTIC agents

Geografische Kategorien: JAPAN, UNITED States

Firma/Körperschaft: UNITED States. Food & Drug Administration

How Pharmaceutical Innovation Benefits From Spatial Aggregation: A Perspective Based on R&D Cooperation Networks.

Autoren: Zhao, Fusen Fan, Jianting

Quelle: Growth & Change; Sep2025, Vol. 56 Issue 3, p1-24, 24p

Schlagwörter: PHARMACEUTICAL industry, INDUSTRIAL concentration, DRUG registration, INNOVATIONS in business, TECHNOLOGICAL innovations, SPATIAL variation, PHARMACEUTICAL technology

Geografische Kategorien: CHINA

Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan.

Autoren: Oku, Yusuke Someya, Hitoshi

Quelle: Frontiers in Pharmacology; 2025, p1-4, 4p

Schlagwörter: DRUG approval, EXPERIMENTAL toxicology, DRUGS, RESEARCH protocols, DRUG registration

Geografische Kategorien: JAPAN, CHINA

Principy léčby SLE dle aktualizace léčebných doručení EULAR 2023 – komentář.

Alternate Title: Principles of treating SLE according to the 2023 EULAR treatment recommendations update – commentary.

Autoren: Horák, P. (AUTHOR)

Quelle: Czech Rheumatology / Česká Revmatologie. 2024, Vol. 32 Issue 3, p107-115. 9p.

Schlagwörter: *DRUG registration, *SYSTEMIC lupus erythematosus, *LUPUS nephritis, *DISEASE remission, *BLOOD diseases

MODELLING AND SIMULATION OF NONLINEAR DYNAMIC FLOW FIELD AND TEMPERATURE FIELD OF DEPYROGENATION TUNNEL.

Autoren: Yizhi Wang Quanmin Zhu Tao Huang et al.

Quelle: Facta Universitatis, Series: Mechanical Engineering. Apr2024, Vol. 22 Issue 1, p45-62. 18p.

Schlagwörter: *DYNAMIC simulation, *DRUG registration, *FLOW velocity, *SIMULATION methods & models, *MANUFACTURING processes

Drug Registration Requirement Process for Kenya and Saudi Arabia

Autoren: Prakruti Patel*1, Rahul Nayak2, Dr. Maitreyi Zaveri3, Dr. Vinit Movaliya4

Schlagwörter: Drug registration, Kenya, Saudi Arabia, regulatory affairs, dossier submission, GMP compliance, pharmaceutical regulations

Depletion of fenbendazole sulfone residues in northern bobwhite (Colinus virginianus) liver following medicated feed treatment.

Autoren: Henry, Brett J Henry, Cassandra Patel, Dhaval et al.

Quelle: Environmental Toxicology & Chemistry; Jun2025, Vol. 44 Issue 6, p1545-1551, 7p

Schlagwörter: NORTHERN bobwhite, GAME & game-birds, WILDLIFE conservation, VETERINARY medicine, DRUG registration

The Art of Bridge Building: A Look at the European-Level Cooperation in HTA (EU-HTA).

Autoren: Ivo, Rui Santos Rodrigues, Tiago Couto, Sara et al.

Quelle: Journal of Market Access & Health Policy; Jun2025, Vol. 13 Issue 2, p26-N.PAG, 5p

Schlagwörter: BUSINESS negotiation, BIOMARKERS, MEDICAL technology, DIGITAL transformation, TECHNOLOGY assessment, DRUG registration, DRUG prices

Unlocking access: a comprehensive analysis of medicines accessibility for rare diseases in Thailand.

Autoren: Suwattanapreeda, Siriwat Hirunrassamee, Sanita Sooksriwong, Chaoncin et al.

Quelle: Orphanet Journal of Rare Diseases; 5/28/2025, Vol. 20 Issue 1, p1-10, 10p

Schlagwörter: RARE diseases, HEALTH insurance, DRUG registration, THAI people, DRUG accessibility, ESSENTIAL drugs, PHARMACEUTICAL industry, ORPHAN drugs

Geografische Kategorien: THAILAND

Changes, Opportunities and Challenges in the Registration and Inspection of Chemical Drugs Produced Overseas in China in the New Era. (English)

Autoren: LI Wenlong MEN Yingxuan WEI Jingjing et al.

Quelle: Chinese Journal of Modern Applied Pharmacy; May2025, Vol. 42 Issue 10, p1686-1690, 5p

Schlagwörter: DRUG registration, EMPLOYMENT in foreign countries, DRUG approval, RECORDING & registration, DRUGS

Analysis and Reflection on Common Issues in Registration Inspection during Drug Registration Review Process. (English)

Autoren: LIN Juan QIAO Litao ZHOU Gang

Quelle: Chinese Journal of Modern Applied Pharmacy; May2025, Vol. 42 Issue 10, p1682-1685, 4p

Schlagwörter: DRUG registration, DRUG use testing, RECORDING & registration

Evolution and Deepening of the Concept of Risk Management in the Construction of the Rule of Law System for Drug Regulation. (English)

Autoren: ZHENG Yujie YU Xuanrong LIU Bolin et al.

Quelle: Chinese Journal of Modern Applied Pharmacy; May2025, Vol. 42 Issue 10, p1630-1634, 5p

Schlagwörter: DRUG side effects, CONSTRUCTION laws, PHARMACEUTICAL policy, DRUG laws, DRUG registration

Advancing Modernization Reform in Pharmaceutical Affairs Management to Catalyze High-Quality Development of Pharmacy Practice. (English)

Autoren: YANG Yifan ZHANG Qingsheng SHAO Rong

Quelle: Chinese Journal of Modern Applied Pharmacy; May2025, Vol. 42 Issue 10, p1626-1629, 4p

Schlagwörter: DRUG registration, DIGITAL transformation, INDUSTRIAL ecology, MODERNIZATION (Social science), PHARMACEUTICAL services

Understanding the State of State Drug Rules: Maintaining a DEA registration is contingent on being licensed as a veterinarian locally.

Autoren: DETWEILER, KELLEY

Quelle: Today's Veterinary Business; Dec2025/Jan2026, Vol. 9 Issue 6, p64-67, 3p

Schlagwörter: DRUG laws, DRUG registration, VETERINARY medicine education

Meta‐analysis of sex and racial subgroup participation rates and differential treatment effects for trials in solid tumor malignancies leading to US Food and Drug Administration registration between 2010 and 2021.

Autoren: Wilson, Brooke E. Nadler, Michelle B. Desnoyers, Alexandra et al.

Quelle: Cancer (0008543X). Jan2024, Vol. 130 Issue 2, p276-286. 11p.

Schlagwörter: *DRUG registration, *PATIENTS, *RACE, *PROGRESSION-free survival, *SURVIVAL rate

Firma/Körperschaft: UNITED States. Food & Drug Administration