Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2022.4226
Abstract: This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements. read more here.
Keywords: new drugs; fda; drugs approved; postmarket commitments ... See more keywords
Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2080
Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first‐in‐world approvals and… read more here.
Keywords: drug lag; new drug; drug; japan ... See more keywords
How excluding some benefits from value assessment of new drugs impacts innovation*
Sign Up to like & getrecommendations! Published in 2017 at "Health Economics"
DOI: 10.1002/hec.3507
Abstract: Payers often assess the benefits of new drugs relative to costs for reimbursement purposes, but they frequently exclude some drugs' option-related benefits, reducing their reimbursement chances, and making them less attractive R&D investments. We develop… read more here.
Keywords: assessment new; excluding benefits; drugs impacts; value assessment ... See more keywords
An Empirical Analysis of Japan's Drug Development Lag Behind the United States.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of clinical pharmacology"
DOI: 10.1002/jcph.2023
Abstract: The "Drug lag" (i.e., the approval lag for new drugs) hinders patients' access to innovative, new medicines. The drug lag had been heavily debated in Japan from the late 2000s to the early 2010s. It… read more here.
Keywords: development; development lag; new drugs; drug ... See more keywords
Evaluation of New Drugs for Asthma and COPD: Endpoints, Biomarkers and Clinical Trial Design.
Sign Up to like & getrecommendations! Published in 2017 at "Handbook of experimental pharmacology"
DOI: 10.1007/164_2016_70
Abstract: There remains a considerable need to develop novel therapies for patients with asthma and chronic obstructive pulmonary disease (COPD). The greatest challenge at the moment is measuring the effects of novel anti-inflammatory drugs, as these… read more here.
Keywords: evaluation new; copd endpoints; asthma copd; copd ... See more keywords
Cervical cancer and potential pharmacological treatment with snake venoms
Sign Up to like & getrecommendations! Published in 2020 at "Molecular Biology Reports"
DOI: 10.1007/s11033-020-05503-6
Abstract: Cervical cancer is the fourth most common cancer worldwide in women. Apoptosis reactivation has become the main strategy for decreasing cancer proliferation. There is a need to extend the search for new drugs to implement… read more here.
Keywords: treatment; snake venoms; cervical cancer; cancer ... See more keywords
Prediction of the Effect of Renal Impairment on the Pharmacokinetics of New Drugs
Sign Up to like & getrecommendations! Published in 2017 at "Clinical Pharmacokinetics"
DOI: 10.1007/s40262-017-0574-9
Abstract: IntroductionRenal impairment may have a significant impact on the pharmacokinetics of drugs. Ad hoc studies in subjects with renal impairment are required by the regulatory authorities to propose dose adjustments in these subjects, to find… read more here.
Keywords: exposure; effect renal; impairment; renal impairment ... See more keywords
Challenges in Designing Clinical Trials to Test New Drugs in the Pregnant Woman and Fetus.
Sign Up to like & getrecommendations! Published in 2019 at "Clinics in perinatology"
DOI: 10.1016/j.clp.2019.02.015
Abstract: The need for new drugs in pregnancy is widely recognized. This review identifies several unique challenges and describes some solutions. Specific studies and drug development programs need careful planning that accounts for the needs of… read more here.
Keywords: challenges designing; test new; designing clinical; clinical trials ... See more keywords
Hepatitis C - New drugs and treatment prospects.
Sign Up to like & getrecommendations! Published in 2019 at "European journal of medicinal chemistry"
DOI: 10.1016/j.ejmech.2019.01.025
Abstract: Hepatitis C virus (HCV) affects approx. 3% of the world's population and accounts for ca 300 000 deaths per year. 80% of individuals with HCV develop chronic symptoms which, when untreated, may cause cirrhosis (27%) or… read more here.
Keywords: treatment; hcv; hepatitis new; treatment prospects ... See more keywords
The Need For Physiological Phenotyping To Develop New Drugs For Airways Disease.
Sign Up to like & getrecommendations! Published in 2020 at "Pharmacological research"
DOI: 10.1016/j.phrs.2020.105029
Abstract: Asthma and COPD make up the majority of obstructive airways diseases (OADs), which affects ∼11% of the population. The main drugs used to treat OADs have not changed in the past five decades, with advancements… read more here.
Keywords: drugs airways; physiological phenotyping; develop new; phenotyping develop ... See more keywords
Exploiting Knowledge on Leishmania Drug Resistance to Support the Quest for New Drugs.
Sign Up to like & getrecommendations! Published in 2017 at "Trends in parasitology"
DOI: 10.1016/j.pt.2016.11.003
Abstract: New drugs are needed to control leishmaniasis and efforts are currently on-going to counter the neglect of this disease. We discuss here the utility and the impact of associating drug resistance (DR) studies to drug… read more here.
Keywords: drug resistance; exploiting knowledge; knowledge leishmania; drug ... See more keywords