Pharmacology, particle deposition and drug administration techniques of intranasal corticosteroids for treating allergic rhinitis | | |
Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021 | | 2022 |
Oncology dose optimization paradigms: knowledge gained and extrapolated from approved oncology therapeutics | | 2022 |
Regulatory Agencies and PET/CT Imaging in the Clinic | | |
Rare disease patients in India are rarely involved in international orphan drug trials | | 2022 |
Postmarketing Colitis Cases Associated With Alpelisib Use Reported to the US Food and Drug Administration | | |
Association between control group therapy and magnitude of clinical benefit of cancer drugs. | | |
Anti-cancer drug combinations approved by US FDA from 2011 to 2021: main design features of clinical trials and role of pharmacokinetics | | |
Comparing timelines and evidence available to support new TB, HIV, and HCV drug approvals: The same, only different | | 2022 |
In vitro and in silico trichomonacidal activity of 2,8-bis(trifluoromethyl) quinoline analogs against Trichomonas vaginalis | | 2022 |
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021 | | 2022 |
Quality of life of children with mucopolysaccharidoses on the background of enzyme replacement therapy | | 2022 |
A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States | Therapeutic Innovation and Regulatory Science | |
In-use stability assessment of FDA approved metformin immediate release and extended release products for N-Nitrosodimethylamine and dissolution quality attributes | International Journal of Pharmaceutics | 2022 |
Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 | JAMA Network Open | 2022 |
Pharmaceutical Supply Chain Reliability and Effects on Drug Shortages | Computers and Industrial Engineering | 2022 |
Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017 | JAMA Health Forum | 2022 |
The importance of an early onset of migraine prevention: an evidence-based, hypothesis-driven scoping literature review | Therapeutic Advances in Neurological Disorders | 2022 |
Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data | PLOS Global Public Health | 2022 |
A Conformational Variant of p53 (U-p53AZ) as Blood-Based Biomarker for the Prediction of the Onset of Symptomatic Alzheimer’s Disease | journal of prevention of Alzheimer's disease, The | |
Osmolality of Excipients for Parenteral Formulation Measured by Freezing Point Depression and Vapor Pressure - A Comparative Analysis. | Pharmaceutical Research | 2022 |
Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration | Acta Marisiensis - Seria Medica | 2022 |
Trend in Blood Pressure Control After Antihypertensive Drug Initiation in the U.S. | American Journal of Preventive Medicine | 2021 |
Role of arginine salts in preventing freezing-induced increase in subvisible particles in protein formulations. | International Journal of Pharmaceutics | 2022 |
Nutrition implications of intrinsic restrictive lung disease. | Nutrition in Clinical Practice | 2022 |
Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications. | Frontiers in Medicine | 2022 |
Approval of Topical Ophthalmic Generic Products in the USA: Simple to Complex Dosage Forms and Establishing Equivalency | AAPS Advances in the Pharmaceutical Sciences Series | 2021 |
Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action. | JAMA Network Open | 2021 |
Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration. | Drug Safety | 2022 |
Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: A Systematic Review and Meta-analysis. | JAMA Oncology | 2022 |
Single-arm clinical trials that supported FDA Accelerated Approvals have modest effect sizes and at high risk of bias. | Journal of Clinical Epidemiology | 2022 |
Obesity and Metabolic Syndrome | | 2022 |
Photodynamic therapy for squamous cell carcinoma of the head and neck: narrative review focusing on photosensitizers | Lasers in Medical Science | 2021 |
Best practices for repurposing studies | Journal of Computer-Aided Molecular Design | 2021 |
SKiM - A generalized literature-based discovery system for uncovering novel biomedical knowledge from PubMed | | |
The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications | Clinical Pharmacology and Therapeutics | 2021 |
Development of the Swiss Database for dosing medicinal products in pediatrics | European Journal of Pediatrics | 2021 |
Diarrhea-Predominant and Constipation-Predominant Irritable Bowel Syndrome: Current Prescription Drug Treatment Options | Drugs | 2021 |
Real-world Use of and Spending on New Oral Targeted Cancer Drugs in the US, 2011-2018 | JAMA Internal Medicine | 2021 |
Accuracy of Psychiatrists' Assessment of Medication Adherence in an Outpatient Setting | Cureus | 2020 |
Drug-Nutrition Interactions in Infectious Diseases | | 2021 |
Fentanyl transdermal patches: Extraction and evaluation of a novel disposal method using NarcX | Journal of Forensic Sciences | 2021 |
Overcoming Cancer Tolerance with Immune Checkpoint Blockade | | 2021 |
Computationally guided high-throughput design of self-assembling drug nanoparticles | | |
Management of QT Prolongation Induced by Anticancer Drugs | Current Clinical Pathology | 2019 |
Hyperprolactinemia after taking Levosulpiride and its Causality Assessment: An Adverse Event Reported by a Community Pharmacy | Korean Journal of Clinical Pharmacy | 2018 |
Research Synergy and Drug Development: Bright Stars in Neighboring Constellations | | |
Analysis of the effects of isotretinoin on the premature epiphyseal closure in pediatric populations: a literature review | Journal of Osteopathic Medicine | 2021 |
Racial and Ethnic Differences in Drug Disposition and Response: Review of New Molecular Entities Approved Between 2014 and 2019 | Journal of Clinical Pharmacology | 2021 |
Exploring the Cognitive Outcomes of Children Prenatally Exposed to Antiseizure Medications: Mind the Lab. | Epilepsy Currents | 2022 |