Works matching DE "DRUG registration"

Results: 234

Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy.

Published in:

2016

By:

Bruyniks, N.;
Nappi, R. E.;
Castelo-Branco, C.;
de Villiers, T. J.;
Simon, J.

Publication type:

journal article

Preclinical studies indicate that INFLATIV, an herbal medicine cream containing Pereskia aculeata, presents potential to be marketed as a topical anti‐inflammatory agent and as adjuvant in psoriasis therapy.

Published in:

Journal of Pharmacy & Pharmacology, 2020, v. 72, n. 12, p. 1933, doi. 10.1111/jphp.13357

By:

Pinto, Nícolas de Castro Campos;
Maciel, Mariana de Souza Ferreira;
Rezende, Nathalia dos Santos;
Duque, Ana Paula do Nascimento;
Mendes, Renata de Freitas;
Silva, Jucélia Barbosa;
Evangelista, Monique de Rezende;
Monteiro, Luana Cahon;
Silva, Josiane Mello;
Costa, Juliana de Carvalho;
Scio, Elita

Publication type:

Article

Chemical and Biological Changes Under Force Degradation and Acceleration Condition of the Combination of Ha‐Rak Remedy, Piper betle, and Garcinia mangostana Extracts for Atopic Dermatitis.

Published in:

Advances in Pharmacological & Pharmaceutical Sciences, 2024, v. 2024, p. 1, doi. 10.1155/2024/4297596

By:

Saesiw, Ubonwan;
Ruangnoo, Srisopa;
Itharat, Arunporn;
Sriumpai, Pattama;
Pavadai, Parasuraman

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

基于中成药说明书 “警示语” 完善的临床药学服务策略.

Published in:

Journal of Beijing University of Traditional Chinese Medicine, 2022, n. 10, p. 979, doi. 10.3969/j.issn.1006-2157.2022.10.002

By:

张冰;
吴昊;
张晓朦;
林志健

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

Practical considerations in the establishment of psychedelic research programs.

Published in:

Psychopharmacology, 2025, v. 242, n. 1, p. 27, doi. 10.1007/s00213-024-06722-6

By:

Barnett, Brian S.;
Vest, M. Frances;
Delatte, Marcus S.;
King IV, Franklin;
Mauney, Erin E.;
Coulson, Anthony J.;
Nayak, Sandeep M.;
Hendricks, Peter S.;
Greer, George R.;
Murnane, Kevin S.

Publication type:

Article

Development and challenges of professional Master of pharmacy education in China.

Published in:

Journal of Chinese Pharmaceutical Sciences, 2021, v. 30, n. 1, p. 69, doi. 10.5246/jcps.2021.01.007

By:

Jie Gu;
Yanli Liu;
Fengguo Xu;
Yongze Zhang;
Rong Shao;
Tao Lu

Publication type:

Article

Mesenchymal stromal cell therapies: immunomodulatory properties and clinical progress.

Published in:

Stem Cell Research & Therapy, 2020, v. 11, n. 1, p. 1, doi. 10.1186/s13287-020-01855-9

By:

Wu, Xiaomo;
Jiang, Ju;
Gu, Zhongkai;
Zhang, Jinyan;
Chen, Yang;
Liu, Xiaolong

Publication type:

Article

Qualitative evaluation of the health insurance program in Nepal: Expectations beyond limitations.

Published in:

World Medical & Health Policy, 2024, v. 16, n. 1, p. 37, doi. 10.1002/wmh3.576

By:

Acharya, Devaraj;
Raikhola, Pushkar S.;
Subedi, Kusum R.;
Devkota, Bhimsen;
Bhattarai, Radha;
Pathak, Krishna P.;
Kreps, Gary L.;
Ghimire, Rabindra

Publication type:

Article

Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP.

Published in:

Journal of Pain Research, 2020, v. 13, p. 1823, doi. 10.2147/JPR.S260761

By:

Priebe, Janosch A;
Haas, Katharina K;
Sanchez, Leida F Moreno;
Schoefmann, Karin;
Utpadel-Fischler, Daniel A;
Stockert, Paul;
Thoma, Reinhard;
Schiessl, Christine;
Kerkemeyer, Linda;
Amelung, Volker;
Jedamzik, Siegfried;
Reichmann, Jan;
Marschall, Ursula;
Toelle, Thomas R

Publication type:

Article

Identifying Valid Algorithms for Number of Lines of Anti-Neoplastic Therapy in the Danish National Patient Registry Among Patients with Advanced Ovarian, Gastric, Renal Cell, Urothelial, and Non-Small Cell Lung Cancer Attending a Danish University Hospital

Published in:

Clinical Epidemiology, 2022, v. 14, p. 159, doi. 10.2147/CLEP.S342238

By:

Sørup, Signe;
Darvalics, Bianka;
Knudsen, Jakob Schöllhammer;
Rasmussen, Anne Staub;
Hjorth, Cathrine Fonnesbech;
Vestergaard, Søren Viborg;
Khalil, Azza Ahmed;
Russo, Leo;
Oksen, Dina;
Boutmy, Emmanuelle;
Verpillat, Patrice;
Rørth, Mikael;
Cronin-Fenton, Deirdre

Publication type:

Article

The Danish National Prescription Registry in studies of a biological pharmaceutical: palivizumab - validation against two external data sources.

Published in:

Clinical Epidemiology, 2015, v. 7, p. 305, doi. 10.2147/CLEP.S73355

By:

Haerskjold, Ann;
Henriksen, Lonny;
Way, Susanne;
Malham, Mikkel;
Hallas, Jesper;
Pedersen, Lars;
Stensballe, Lone Graff

Publication type:

Article

Efficacy and safety of Elian Granules in treating chronic atrophic gastritis: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial.

Published in:

2022

By:

Gu, Zhijian;
Jia, Qingling;
Cong, Jun;
Cen, Rong;
Chen, Yongqi;
Wu, Chenheng;
Gong, Biao;
Tang, Xudong;
Ling, Jianghong

Publication type:

journal article

How do I: Evaluate the safety and legitimacy of unproven cellular therapies?

Published in:

Transfusion, 2022, v. 62, n. 3, p. 518, doi. 10.1111/trf.16814

By:

Guleria, Indira;
de Los Angeles Muñiz, Maria;
Wilgo, Matthew;
Bapat, Asawari;
Cui, Wanxing;
Hsu, Yen‐Michael Sheng;
Jeyaraman, Madhan;
Muthu, Sathish;
Rodriguez, Federico;
Fesnak, Andrew;
Celluzzi, Christina;
Sesok‐Pizzini, Deborah;
Reich‐Slotky, Ronit;
Spitzer, Thomas

Publication type:

Article

Standardized electronic transfer of blood product information.

Published in:

Transfusion, 2021, v. 61, n. 4, p. 1324, doi. 10.1111/trf.16294

By:

Ashford, Paul;
Moniz, Karen

Publication type:

Article

Evaluating blood product quality post expiry to mitigate blood shortages during the COVID-19 pandemic in Canada.

Published in:

2020

By:

Turner, Tracey R.;
Olafson, Carly;
Mykhailova, Olga;
Xu, April;
Acker, Jason P.

Publication type:

Letter

Rapid establishment of a COVID‐19 convalescent plasma program in a regional health care delivery network.

Published in:

Transfusion, 2020, v. 60, n. 10, p. 2203, doi. 10.1111/trf.16026

By:

Blackall, Douglas;
Wulff, Shephali;
Roettger, Timothy;
Jacobs, Lauren;
Lacasse, Alexandre;
Patri, Manokiran;
Zinser, Phillip;
Pherez, Francisco;
Jamkhana, Zafar;
Frey, Sharon E.;
Smith, Linda;
Goel, Ruchika;
Katz, Louis

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

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

Chronological Review and Rational and Future Prospects of Cannabis-Based Drug Development.

Published in:

Molecules, 2020, v. 25, n. 20, p. 4821, doi. 10.3390/molecules25204821

By:

Namdar, Dvora;
Anis, Omer;
Poulin, Patrick;
Koltai, Hinanit;
Busardò, Francesco Paolo

Publication type:

Article

Validation of data quality in the National Swedish Kidney Cancer Register.

Published in:

Scandinavian Journal of Urology, 2021, v. 55, n. 2, p. 142, doi. 10.1080/21681805.2021.1885485

By:

Landberg, Anna;
Bruce, Daniel;
Lindblad, Per;
Ljungberg, Börje;
Lundstam, Sven;
Thorstenson, Andreas;
Sundqvist, Pernilla

Publication type:

Article

Time for clinical decision support systems tailoring individual patient therapy to improve renal and cardiovascular outcomes in diabetes and nephropathy.

Published in:

Nephrology Dialysis Transplantation, 2020, v. 35, p. ii38, doi. 10.1093/ndt/gfaa013

By:

Zeeuw, Dick de;
Heerspink, Hiddo J L

Publication type:

Article

Observational studies: it's time to be transparent.

Published in:

British Journal of Dermatology, 2023, v. 188, n. 4, p. 449, doi. 10.1093/bjd/ljac099

By:

Gran, Sonia;
Apfelbacher, Christian;
Hollestein, Loes M

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

A new medicine for the treatment of X-linked hypophosphataemia, a rare bone disease: Recommended for conditional approval.

Published in:: Medical Writing, 2018, v. 27, n. 1, p. 72
Publication type:: Article

New medicine for multiple sclerosis.

Published in:: Medical Writing, 2018, v. 27, n. 1, p. 69
Publication type:: Article

Launch of PRIME - Paving the way for promising medicines for patients.

Published in:: Medical Writing, 2016, v. 25, n. 2, p. 38
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

Safety and efficacy of health supplement for weight loss.

Published in:

Archives of Pharmacy Practice, 2016, v. 7, p. S11, doi. 10.4103/2045-080X.183031

By:

Ibrahim, Saliza;
Choon Wai Yee, June;
Gupta, Manish;
Murugiah, Muthu Kumar;
Long Chiau Ming

Publication type:

Article

Safety and efficacy of health supplement (Pegaga based product).

Published in:

Archives of Pharmacy Practice, 2016, v. 7, p. S29, doi. 10.4103/2045-080X.183034

By:

Rahman, Firdaus Abd;
Chua Say Tiong;
Kah Seng Lee;
Abdullah, Amir Heberd;
Long Chiau Ming

Publication type:

Article

Regulation of stability studies to enhance the efficiency of drug registrations to regulatory authorities.

Published in:

Archives of Pharmacy Practice, 2015, v. 6, n. 3, p. 48, doi. 10.4103/2045-080X.160990

By:

Khan, Mohammad Sajjad;
Akhtar, Nabila

Publication type:

Article

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study.

Published in:

Journal of Young Pharmacists, 2022, v. 14, n. 1, p. 33, doi. 10.5530/jyp.2022.14.7

By:

D. S., Sandeep;
C. R., Sowmya;
V., Anoop Narayanan;
M. P., Gowrav

Publication type:

Article

Regulation of Long-Term Care Homes for Older Adults in India.

Published in:

Indian Journal of Psychological Medicine, 2021, v. 43, p. S88, doi. 10.1177/02537176211021785

By:

Harbishettar, Vijaykumar;
Gowda, Mahesh;
Tenagi, Saraswati;
Chandra, Mina

Publication type:

Article

Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality.

Published in:

Pharmaceutical Medicine, 2022, v. 36, n. 4, p. 223, doi. 10.1007/s40290-022-00432-0

By:

Hashan, Hajed M.;
Al-Muteb, Sarah K.;
Alismail, Ibrahim A.;
Alsaleh, Othman N.;
Alkherb, Zakiya M.;
McAuslane, Neil;
Walker, Stuart R.

Publication type:

Article

Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?

Published in:

Pharmaceutical Medicine, 2019, v. 33, n. 5, p. 407, doi. 10.1007/s40290-019-00302-2

By:

Maliepaard, Marc;
Taams, Anne C.;
Sung, Cynthia;
Poh, Jalene;
Yu, Yang

Publication type:

Article

Influence of Breakthrough Therapy Designation in the United States on Oncology Drug Development Timelines in Japan.

Published in:

Pharmaceutical Medicine, 2018, v. 32, n. 3, p. 201, doi. 10.1007/s40290-018-0236-8

By:

Tanaka, Makoto;
Matsumaru, Naoki;
Tsukamoto, Katsura

Publication type:

Article

International Comparison of Five Herbal Medicine Registration Systems to Inform Regulation Development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain.

Published in:

Pharmaceutical Medicine, 2018, v. 32, n. 1, p. 39, doi. 10.1007/s40290-018-0223-0

By:

Alostad, Azhar H.;
Steinke, Douglas T.;
Schafheutle, Ellen I.

Publication type:

Article

How diversification affects vertical integration through experience in pharmaceuticals.

Published in:

Journal of Technology Management & Innovation, 2018, v. 13, n. 4, p. 3, doi. 10.4067/S0718-27242018000400003

By:

Nogueira, Antonio Carlos Lima;
Bataglia, Walter

Publication type:

Article

Use of likelihood estimates for variances for the design and evaluation of multiregional clinical trials with heterogeneous variances.

Published in:

Statistics in Medicine, 2022, v. 41, n. 1, p. 87, doi. 10.1002/sim.9224

By:

Wu, Yuh‐Jenn;
Cheng, Yu‐Chieh;
Chiang, Chieh;
Cheng, Li‐Hsueh;
Liu, Ching‐Ti;
Hsiao, Chin‐Fu

Publication type:

Article

Bayesian methods to compare dose levels with placebo in a small n, sequential, multiple assignment, randomized trial.

Published in:

Statistics in Medicine, 2021, v. 40, n. 4, p. 963, doi. 10.1002/sim.8813

By:

Fang, Fang;
Hochstedler, Kimberly A.;
Tamura, Roy N.;
Braun, Thomas M.;
Kidwell, Kelley M.

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

Fast-tracking of new drugs: getting the balance right.

Published in:

2018

By:

Kubler, Paul

Publication type:

Editorial

Impact of the Pharmacy Practice Model Initiative on Clinical Pharmacy Specialist Practice: An Alternative Viewpoint.

Published in:

Pharmacotherapy, 2016, v. 36, n. 11, p. e195, doi. 10.1002/phar.1844

By:

Potter, Lisa M.;
Tichy, Eric M.;
Horwedel, Timothy A.;
Shullo, Michael A.;
Ensor, Christopher R.;
Pilch, Nicole A.;
Cochrane, Adam B.;
Maldonado, Angela Q.;
Jacobi, Judith;
Sam, Teena

Publication type:

Article

"Zebrafish as an animal model for food safety research: trends in the animal research".

Published in:

Food Biotechnology, 2019, v. 33, n. 4, p. 283, doi. 10.1080/08905436.2019.1673173

By:

Bailone, Ricardo Lacava;
Aguiar, Luís de;
Roca, Roberto de Oliveira;
Borra, Ricardo Carneiro;
Corrêa, Tatiana;
Junke, Helena;
Fukushima, Hirla Costa Silva

Publication type:

Article

ANVISA: an introduction to a new regulatory agency with many challenges.

Published in:

AAPS Open, 2018, v. 4, n. 1, p. 1, doi. 10.1186/s41120-018-0029-x

By:

Huynh-Ba, Kim;
Beumer Sassi, Alexandra

Publication type:

Article