Works matching DE "DRUG registration"

Results: 238

Adaptive Budgets in Clinical Trials.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 4, p. 282, doi. 10.1080/19466315.2013.783504

By:

Posch, Martin;
Bauer, Peter

Publication type:

Article

抗肿瘤药物Ⅰ期临床试验质量管理要点.

Published in:

Cancer Research on Prevention & Treatment, 2025, v. 52, n. 5, p. 347, doi. 10.3971/j.issn.1000-8578.2025.24.1178

By:

龚莉;
廖斌;
沈杰;
赵娟;
龚奕;
卢潇潇;
杨辉尧;
李沙;
李咏生

Publication type:

Article

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

Published in:

Orphanet Journal of Rare Diseases, 2025, v. 20, n. 1, p. 1, doi. 10.1186/s13023-025-03754-9

By:

Suwattanapreeda, Siriwat;
Hirunrassamee, Sanita;
Sooksriwong, Chaoncin;
Maluangnon, Kusawadee;
Chuachantra, Thirapich;
Kuchaisit, Krissana;
Osirisakul, Niti

Publication type:

Article

Remembrance of six prominent Serbian toxicologists who died during 2020 and 2021.

Published in:

Vojnosanitetski Pregled: Military Medical & Pharmaceutical Journal of Serbia, 2023, v. 80, n. 7, p. 631, doi. 10.2298/VSP220422085T

By:

Todorović, Veljko

Publication type:

Article

Market approval for drugs in the EU: time to change direction?

Published in:

2017

By:

Curto, Alessandro;
de Vooren, Katelijne;
Garattini, Livio;
van de Vooren, Katelijne

Publication type:

Editorial

Veterinary Cooperative Oncology Group—Common Terminology Criteria for Adverse Events (VCOG‐CTCAE v2) following investigational therapy in dogs and cats.

Published in:

Veterinary & Comparative Oncology, 2021, v. 19, n. 2, p. 311, doi. 10.1111/vco.12677

By:

LeBlanc, Amy K.;
Atherton, Matthew;
Bentley, R. Timothy;
Boudreau, C. Elizabeth;
Burton, Jenna H.;
Curran, Kaitlin M.;
Dow, Steven;
Giuffrida, Michelle A.;
Kellihan, Heidi B.;
Mason, Nicola J.;
Oblak, Michelle;
Selmic, Laura E.;
Selting, Kimberly A.;
Singh, Ameet;
Tjostheim, Sonja;
Vail, David M.;
Weishaar, Kristen M.;
Berger, Erika P.;
Rossmeisl, John H.;
Mazcko, Christina

Publication type:

Article

Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients.

Published in:

Dermatology (10188665), 2022, v. 238, n. 4, p. 615, doi. 10.1159/000519924

By:

Drerup, Katharina A.;
Seemann, Claudia;
Gerdes, Sascha;
Mrowietz, Ulrich

Publication type:

Article

Medication without harm: "know, check, ask, record and report".

Published in:

SA Pharmaceutical Journal Incorporating Pharmacy Management, 2022, v. 89, n. 6, p. 33

By:

Misra, Nirupa;
Chetty, Kaajal

Publication type:

Article

Persistence with Denosumab in Women at High Risk of Fracture in Bulgaria.

Published in:

Rheumatology & Therapy, 2021, v. 8, n. 1, p. 443, doi. 10.1007/s40744-021-00282-3

By:

Monov, Simeon;
Nestorova, Rodina;
Velkova, Margarita;
Boyanov, Mihail;
Jeleva, Silvia;
Petkova, Renata;
Petranova, Tzvetanka

Publication type:

Article

Views of European Drug Development Stakeholders on Treatment Optimization and Its Potential for Use in Decision-Making.

Published in:

Frontiers in Pharmacology, 2020, p. 1, doi. 10.3389/fphar.2020.00043

By:

Saesen, Robbe;
Lejeune, Stéphane;
Quaglio, Gianluca;
Lacombe, Denis;
Huys, Isabelle

Publication type:

Article

The promise of paediatric dolutegravir.

Published in:

Journal of the International AIDS Society, 2021, v. 24, n. 1, p. 1, doi. 10.1002/jia2.25660

By:

Golin, Rachel;
Samuel, Jeffrey M;
Phelps, B Ryan;
Persaud, Udita;
Malati, Christine Y;
Siberry, George K

Publication type:

Article

Has resourcing of non‐governmental harm‐reduction organizations in Ukraine improved HIV prevention and treatment outcomes for people who inject drugs? Findings from multiple bio‐behavioural surveys.

Published in:

Journal of the International AIDS Society, 2020, v. 23, n. 8, p. 1, doi. 10.1002/jia2.25608

By:

Trickey, Adam;
Semchuk, Nadiya;
Saliuk, Tetiana;
Sazonova, Yana;
Varetska, Olga;
Walker, Josephine G;
Lim, Aaron G;
Stone, Jack;
Vickerman, Peter

Publication type:

Article

Optimizing predictive performance of criminal recidivism models using registration data with binary and survival outcomes.

Published in:

PLoS ONE, 2019, v. 14, n. 3, p. 1, doi. 10.1371/journal.pone.0213245

By:

Tollenaar, Nikolaj;
van der Heijden, Peter G. M.

Publication type:

Article

Severity of depression, anxious distress and the risk of type 2 diabetes - a population-based cohort study in Sweden.

Published in:

2019

By:

Deleskog, Anna;
Ljung, Rickard;
Forsell, Yvonne;
Nevriana, Alicia;
Almas, Aysha;
Möller, Jette

Publication type:

journal article

Knowledge and provision of misoprostol among pharmacy workers in Senegal: a cross sectional study.

Published in:

2017

By:

Reiss, Kate;
Footman, Katharine;
Burke, Eva;
Diop, Nafissatou;
Ndao, Ramatoulaye;
Mane, Babacar;
van Min, Maaike;
Ngo, Thoai D.

Publication type:

journal article

Lessons from the United Kingdom's COVID-19 vaccination strategy.

Published in:

2021

By:

Harnden, Anthony;
Earnshaw, Andrew

Publication type:

Editorial

Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council.

Published in:

Journal of Generic Medicines, 2022, v. 18, n. 2, p. 82, doi. 10.1177/17411343211029995

By:

Charyulu, Narayana R;
Narayanan, Anoop V;
Shetty, Amitha

Publication type:

Article

Refining animal research: The Animal Study Registry.

Published in:

PLoS Biology, 2019, v. 17, n. 10, p. 1, doi. 10.1371/journal.pbio.3000463

By:

Bert, Bettina;
Heinl, Céline;
Chmielewska, Justyna;
Schwarz, Franziska;
Grune, Barbara;
Hensel, Andreas;
Greiner, Matthias;
Schönfelder, Gilbert

Publication type:

Article

Technology: Barriers to misuse.

Published in:

Nature, 2015, v. 522, n. s7557, p. S60, doi. 10.1038/522S60a

By:

Dolgin, Elie

Publication type:

Article

Is it new, is it true and do we care—the role of prospective review registration.

Published in:

Human Reproduction Update, 2023, v. 29, n. 5, p. 519, doi. 10.1093/humupd/dmad022

By:

Wely, Madelon van;
Hastings, Julie M;
Tarlatzis, Basil;
Sunde, Arne

Publication type:

Article

Insights from outside BJOG.

Published in:

BJOG: An International Journal of Obstetrics & Gynaecology, 2020, v. 127, n. 9, p. 1045, doi. 10.1111/1471-0528.16348

By:

Kent, Athol;
Kirtley, Shona

Publication type:

Article

Regulatory Requirements and Registration Procedure for Generic Drugs in USA.

Published in:

Indian Journal of Pharmaceutical Education & Research, 2018, v. 52, n. 4, p. 544, doi. 10.5530/ijper.52.4.63

By:

Rafi, Naziya;
Sandeep D. S.;
Anoop Narayanan V.

Publication type:

Article

A lacuna regulatória de medicamentos órfãos impacta na disponibilidade de alternativas terapêuticas no Brasil?

Published in:

Revista Colombiana de Ciencias Químico-Farmacéuticas, 2022, v. 51, n. 2, p. 735, doi. 10.15446/rcciquifa.v51n2.98783

By:

de Matos Lopes, Francyelle Rodrigues;
Monsores de Sá, Natan;
Fonseca Lima, Rodrigo;
Leão Tavares, Noemia Urruth;
Santos Santana, Rafael

Publication type:

Article

Optimizando farmacoterapia mediante la deprescripción: reporte de caso.

Published in:

Revista Colombiana de Ciencias Químico-Farmacéuticas, 2020, v. 49, n. 1, p. 17, doi. 10.15446/rcciquifa.v49n1.86736

By:

Vallejos Narváez, Álvaro;
Díaz Rodríguez, Viviana Andrea;
Preciado Correal, Gloria Marcela

Publication type:

Article

Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study.

Published in:

Antibiotics (2079-6382), 2020, v. 9, n. 8, p. 511, doi. 10.3390/antibiotics9080511

By:

Fajfr, Miroslav;
Balik, Michal;
Cermakova, Eva;
Bostik, Pavel

Publication type:

Article

Comparing Pharmacotherapies for ADHD in Adults: Evidence From Outcome-Focused Analysis of Food and Drug Administration Drug Label Registration Trials.

Published in:

Journal of Attention Disorders, 2024, v. 28, n. 5, p. 800, doi. 10.1177/10870547231218041

By:

Surman, Craig B. H.;
Walsh, Daniel M.;
Bond, Joseph B.

Publication type:

Article

Reducing Initial Loss to Follow-up Among People With Bacteriologically Confirmed Tuberculosis: LINKEDin, a Quasi-experimental Study in South Africa.

Published in:

Open Forum Infectious Diseases, 2024, v. 11, n. 1, p. 1, doi. 10.1093/ofid/ofad648

By:

Meehan, Sue-Ann;
Hesseling, Anneke C;
Boulle, Andrew;
Chetty, Jolene;
Connell, Lucy;
Dlamini-Miti, Nomthandazo J;
Dunbar, Rory;
Preez, Karen Du;
George, Gavin;
Hoddinott, Graeme;
Jennings, Karen;
Marx, Florian M;
Mudaly, Vanessa;
Naidoo, Pren;
Ndlovu, Neo;
Ngozo, Jacqueline;
Smith, Mariette;
Strauss, Michael;
Tanna, Gaurang;
Vanqa, Nosivuyile

Publication type:

Article

Pharmacometrics in Australasia—Twenty Years of Population Approach Group of Australia and New Zealand.

Published in:

CPT: Pharmacometrics & Systems Pharmacology, 2019, v. 8, n. 10, p. 701, doi. 10.1002/psp4.12460

By:

Hennig, Stefanie;
Hannam, Jacqueline A.;
Kirkpatrick, Carl M.J.;
Staatz, Christine E.;
Holford, Sam;
Duffull, Stephen B.;
Al‐Sallami, Hesham S.;
Charles, Bruce G.;
Holford, Nick;
Foster, David J.R.

Publication type:

Article

Spatiotemporal 3D image registration for mesoscale studies of brain development.

Published in:

Scientific Reports, 2022, v. 12, n. 1, p. 1, doi. 10.1038/s41598-022-06871-8

By:

Shuvaev, Sergey;
Lazutkin, Alexander;
Kiryanov, Roman;
Anokhin, Konstantin;
Enikolopov, Grigori;
Koulakov, Alexei A.

Publication type:

Article

Review of the Chinese Landscape in Phase 1 Clinical Trials for Noncancer Innovative Drugs Over 2015 to 2020.

Published in:

Clinical Pharmacology in Drug Development, 2022, v. 11, n. 8, p. 903, doi. 10.1002/cpdd.1131

By:

Wu, Xiaofei;
Zhang, Fan;
Yu, Mengyang;
Wang, Hongyun

Publication type:

Article

Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 5, p. 434, doi. 10.1002/cpdd.942

By:

Asada, Ryuta;
Shimizu, Shinobu;
Nakamura, Harumasa;
Ono, Shunsuke;
Yamaguchi, Takuhiro

Publication type:

Article

Evaluating machine learning-enabled and multimodal data-driven exercise prescriptions for mental health: a randomized controlled trial protocol.

Published in:

Frontiers in Psychiatry, 2024, p. 1, doi. 10.3389/fpsyt.2024.1352420

By:

Miaoqing Tan;
Yanning Xiao;
Fengshi Jing;
Yewei Xie;
Sanmei Lu;
Mingqiang Xiang;
Hao Ren

Publication type:

Article

Assessment of the implementation of accelerated drug marketing registration procedures for antineoplastic and immunomodulating agents in China: based on 2016-2022 review data.

Published in:

Frontiers in Pharmacology, 2024, p. 1, doi. 10.3389/fphar.2024.1345672

By:

Yipeng Lan;
Xiaofeng Lin;
Jialin Yu;
Li Wang;
Lihua Sun;
Zhe Huang

Publication type:

Article

Comparative analysis of classification techniques for topic-based biomedical literature categorisation.

Published in:

Frontiers in Genetics, 2023, p. 01, doi. 10.3389/fgene.2023.1238140

By:

Stepanov, Ihor;
Ivasiuk, Arsentii;
Yavorskyi, Oleksandr;
Frolova, Alina

Publication type:

Article

Enhanced communication of IARC Monograph findings to better achieve public health outcomes.

Published in:

Carcinogenesis, 2021, v. 42, n. 2, p. 159, doi. 10.1093/carcin/bgaa129

By:

Stewart, Bernard W

Publication type:

Article

Biyolojik olmayan kompleks ilaçlar.

Published in:

Turkish Bulletin of Hygiene & Experimental Biology / Türk Hijyen ve Deneysel Biyoloji, 2019, v. 76, n. 2, p. 221, doi. 10.5505/TurkHijyen.2018.95770

By:

CESUR, Büşra;
DEMİR-DORA, Devrim

Publication type:

Article

How Generic Drugs are Registered in Europe, United Kingdom, Australia and New Zealand? - A Drug Regulatory Perspective.

Published in:

International Journal of Pharmaceutical Investigation, 2023, v. 13, n. 3, p. 440, doi. 10.5530/ijpi.13.3.055

By:

D. S., Sandeep;
Y. K., Lavanya;
T., Shailesh

Publication type:

Article

Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC).

Published in:

International Journal of Pharmaceutical Investigation, 2020, v. 10, n. 3, p. 263, doi. 10.5530/ijpi.2020.3.48

By:

Murali, Reshma Pushpa;
Castelino, Lovely Joylen;
Shriram, Ravi Gundadka;
Dubey, Akhilesh

Publication type:

Article

Ethics committee accreditation: Journey from voluntariness to essentiality for quality sustenance.

Published in:

Perspectives in Clinical Research, 2024, v. 15, n. 2, p. 51, doi. 10.4103/picr.picr_45_24

By:

Tripathi, Raakhi K.

Publication type:

Article

Analyzability of newly developed/commercially promoted drugs among young medical and dental doctors.

Published in:

Perspectives in Clinical Research, 2021, v. 12, n. 1, p. 27, doi. 10.4103/picr.PICR_56_19

By:

Gupta, Sonu;
Bansal, Ravinder

Publication type:

Article

The use of 2D fingerprint methods to support the assessment of structural similarity in orphan drug legislation.

Published in:

Journal of Cheminformatics, 2014, v. 6, n. 1, p. 1, doi. 10.1186/1758-2946-6-5

By:

Franco, Pedro;
Porta, Nuria;
Holliday, John;
Willett, Peter

Publication type:

Article

Combinations of registered drugs reduce treatment times required to deplete Wolbachia in the Litomosoides sigmodontis mouse model.

Published in:

PLoS Neglected Tropical Diseases, 2018, v. 12, n. 1, p. 1, doi. 10.1371/journal.pntd.0006116

By:

Specht, Sabine;
Pfarr, Kenneth M.;
Arriens, Sandra;
Hübner, Marc P.;
Klarmann-Schulz, Ute;
Koschel, Marianne;
Sternberg, Sonja;
Martin, Coralie;
Ford, Louise;
Taylor, Mark J.;
Hoerauf, Achim

Publication type:

Article

A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria.

Published in:

PLoS ONE, 2015, v. 10, n. 7, p. 1, doi. 10.1371/journal.pone.0129545

By:

Mbonye, Anthony K.;
Magnussen, Pascal;
Lal, Sham;
Hansen, Kristian S.;
Cundill, Bonnie;
Chandler, Clare;
Clarke, Siân E.

Publication type:

Article

The Final Stretch to DSCSA Implementation.

Published in:

Journal of Health Care Compliance, 2023, v. 25, n. 2, p. 25

By:

Benson, John P.

Publication type:

Article

General characteristics and reasons for the discontinuation of drug clinical trials in mainland China.

Published in:

2021

By:

Huo, Ben-nian;
Ai, Mao-lin;
Jia, Yun-tao;
Liu, Yao;
Wang, Yang;
Yin, Nan-ge;
Song, Lin

Publication type:

journal article

The prevalence and prescribing patterns of benzodiazepines and Z-drugs in older nursing home residents in different European countries and Israel: retrospective results from the EU SHELTER study.

Published in:

2021

By:

Lukačišinová, Anna;
Fialová, Daniela;
Peel, Nancye May;
Hubbard, Ruth Eleanor;
Brkic, Jovana;
Onder, Graziano;
Topinková, Eva;
Gindin, Jacob;
Shochat, Tamar;
Gray, Leonard;
Bernabei, Roberto

Publication type:

journal article

ANDA Submissions - Refuse to Receive (RTR) Standards and Deficiencies of CTD modules in ANDA.

Published in:

International Journal of Pharmaceutical Research (09752366), 2021, v. 13, n. 2, p. 2642, doi. 10.31838/ijpr/2021.13.02.357

By:

P. A., SHERMILAN;
KAMARAJ, RAJU

Publication type:

Article

Regulatory Filing of Generic Drugs in Europe.

Published in:

International Journal of Pharmaceutical Research (09752366), 2021, v. 13, n. 2, p. 2516, doi. 10.31838/ijpr/2021.13.02.351

By:

S., SOORIA;
KAMARAJ, RAJU;
KARUPPAIAH, SONIA

Publication type:

Article

Challenges and Prospects for Filing Certificate of Suitability in Europe.

Published in:

International Journal of Pharmaceutical Research (09752366), 2021, v. 13, n. 2, p. 2508, doi. 10.31838/ijpr/2021.13.02.350

By:

S., ANANDH;
KAMARAJ, RAJU;
SUGUMARAN, ABIMANYU

Publication type:

Article

THE DISTRIBUTION OF INTRAVENOUS DRUG USERS IN THE MUNICIPALITY OF GOSTIVAR IN THE PERIOD OF 2012-2017.

Published in:

Vizione, 2019, n. 33, p. 259

By:

VRAYNKO, Adnan

Publication type:

Article