Results 11 to 20 of about 454,627 (348)

Pharmacists’ Knowledge and Perceptions of FDA Approval Standards and the Breakthrough Therapy Designation

Pharmacy, 2022
The “breakthrough therapy” designation (BTD) is a recent mechanism implemented by the United States Food and Drug Administration (FDA) to expedite access to drugs that address unmet needs.
Megan C. Herink, Kirbee Johnston, Kristin Breninger, Erin Wu, Adriane N. Irwin   +4 more
doaj   +1 more source

Comparison of pharmacogenomic information for drug approvals provided by the national regulatory agencies in Korea, Europe, Japan, and the United States

Frontiers in Pharmacology, 2023
Pharmacogenomics, which is defined as the study of changes in the properties of DNA and RNA associated with drug response, enables the prediction of the efficacy and adverse effects of drugs based on patients’ specific genetic mutations. For the safe and
Mijin Lee, Ji Min Han, Jaeyeon Lee, Ju Young Oh, Jung Sun Kim, Hye Sun Gwak, Kyung Hee Choi   +6 more
doaj   +1 more source

Community Labeling: Former Drug Convicts Become Drug Convicts Again

Digital Press Social Sciences and Humanities, 2023
This research was motivated by the discovery of information about ex-drug convicts at Class IIB Padang prison who returned to drug convicts after repeating the same incident.
Mira Hasti Hasmira, Suhai Ratu Rahmi
doaj   +1 more source

A survey of Top 200 Drugs—Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms [PDF]

, 2012
Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases.
Prohotsky, Daniel, Zhao, Fang
core   +2 more sources

Fair Hearing in Administrative Rule-Making: A Recent Experience Under the Federal Food, Drug, and Cosmetic and Fair Packaging and Labeling Acts [PDF]

, 1968
In promulgating regulations to govern the labeling of foods under the Fair Packaging and Labeling Act, the Commissioner of Food and Drugs, despite the objections of adversely affected parties, denied all requests for a public hearing. In this article the
Forte, Wesley E.
core   +2 more sources

Nutrition Labeling in the United States and the Role of Consumer Processing, Message Structure, and Moderating Conditions [PDF]

, 2017
It has been since 1990 that the landmark Nutritional Labeling Education Act (NLEA) was passed in the United States, and since 1969 that the first White House Conference on Food, Nutrition and Health occurred.
Andrews, J. Craig, Burton, Scot, Cook, Laurel Aynne   +2 more
core   +2 more sources

Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015

Frontiers in Pharmacology, 2019
Background: Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical
Isabel Hurtado-Navarro, Isabel Hurtado-Navarro, Aníbal García-Sempere, Aníbal García-Sempere, Clara Rodríguez-Bernal, Clara Rodríguez-Bernal, José Sanfélix-Genovés, José Sanfélix-Genovés, Salvador Peiró, Salvador Peiró, Gabriel Sanfélix-Gimeno, Gabriel Sanfélix-Gimeno   +11 more
doaj   +1 more source

Do asian patients require only half of the clozapine dose prescribed for caucasians? A critical overview

Indian Journal of Psychological Medicine, 2020
Since 1997, studies have found that Asians need lower clozapine doses than Caucasians. Caucasians with average clozapine metabolism may need from 300 to 600 mg/day to reach the therapeutic range (350 ng/ml). Thus, serum clozapine concentration-to-dose (C/
Jose de Leon, Anto P Rajkumar, Arun R Kaithi, Georgios Schoretsanitis, John M Kane, Chuan-Yue Wang, Yi-Lang Tang, Shih-Ku Lin, Kyung Sue Hong, Saeed Farooq, Chee H Ng, Can-Jun Ruan, Chittaranjan Andrade   +12 more
doaj   +1 more source

Guessability of U.S. pharmaceutical pictograms in Iranian prospective users

Pharmacy Practice, 2020
Objective: This study examined the gueassability of US pharmaceutical pictograms as well as associated demographic factors and cognitive design features among Iranian adults. Methods: A total of 400 participants requested to guess the meaning of 53 US
Mahnaz Saremi , Zeinab S. Shekaripour , Soheila Khodakarim   +2 more
doaj   +1 more source

Cardiovascular Drug Labeling: Do They Have Information on Necessary Precautions for Older People? [PDF]

Geriatrics, Gerontology and Aging
OBJECTIVE: To analyze the existence of information on drug labeling intended for health professionals on the precaution of cardiovascular drugs use in older people.
Lucas Oliveira Marques, Roberta Coutinho Vasconcelos, André Oliveira Baldoni, Ana Cristina Nogueira Rodrigues Pestana, Farah Maria Drumond Chequer   +4 more
doaj   +1 more source