Results 61 to 70 of about 1,710,685 (294)

In vitro toxicity model: Upgrades to bridge the gap between preclinical and clinical research

open access: yesBiomolecules & Biomedicine, 2020
The Centers for Disease Control and Prevention (CDC) provides extensive data that indicate our need for drugs to maintain human population health. Despite the substantial availability of drugs on the market, many patients lack specific drugs.
Eneko Madorran   +3 more
doaj   +1 more source

Cognitive Functioning in Vorinostat‐Treated Pediatric and Young Adult Patients Over the First 180 Days After Hematopoietic Stem Cell Transplant

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Purpose Cognitive and psychological difficulties could negatively interfere with treatment adherence and quality of life before and after hematopoietic stem cell transplant (HSCT). Methods to mitigate these changes may have positive effects on treatment success.
Kristen L. Votruba   +11 more
wiley   +1 more source

A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]

open access: yes, 2007
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core   +1 more source

Maraviroc: integration of a new antiretroviral drug class into clinical practice [PDF]

open access: yes, 2008
Maraviroc (Pfizer's UK-427857, Selzentry or Celsentri outside the US) is the first agent in the new class of oral HIV-1 entry inhibitors to acquire FDA and EMEA approval.
Vandekerckhove, Linos   +2 more
core   +2 more sources

Adverse drug reactions associated with amitriptyline - protocol for a systematic multiple-indication review and meta-analysis [PDF]

open access: yes, 2020
Background: Unwanted anticholinergic effects are both underestimated and frequently overlooked. Failure to identify adverse drug reactions (ADRs) can lead to prescribing cascades and the unnecessary use of over-thecounter products.
Brueckle, Maria-Sophie   +9 more
core   +1 more source

Evaluation of the Utility of Baseline Echocardiogram in Patients With Standard Risk Precursor B‐Lymphoblastic Leukemia

open access: yesPediatric Blood &Cancer, EarlyView.
Abstract Background A routine baseline echocardiogram is often obtained prior to anthracycline administration in children with cancer. The utility of baseline echocardiogram is unclear in patients with standard risk B‐cell acute lymphoblastic leukemia (SR B‐ALL) as their anthracycline cumulative dose is low.
Ziyad Alrajhi   +4 more
wiley   +1 more source

The drug approval tactician [PDF]

open access: yesNature Reviews Drug Discovery, 2003
Regulatory affairs in the pharmaceutical industry is both a familiar and unfamiliar world. The industry is well known as being one of the most highly regulated, revolving around the approval of new compounds that emerge from the drug development pipeline by national or multinational regulatory bodies.
openaire   +2 more sources

CPX‐351 in High‐Risk Relapsed Pediatric Acute Leukemia: Real‐World Phase 1 Data Establishing the FDA‐Approved Dose

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Background/Objectives Outcomes for pediatric relapsed/refractory (R/R) acute myeloid leukemia (AML) remain dismal. CPX‐351, a liposomal formulation of cytarabine and daunorubicin, may have less off‐target toxicities than traditional chemotherapies and has shown improved outcomes for adults with newly diagnosed therapy‐related AML.
Jonathan D. Bender   +17 more
wiley   +1 more source

Incidence and Risk Factors of Serious Osteonecrosis in Pediatric Acute Lymphoblastic Leukemia: A CYP‐C Population‐Based Study

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Background Osteonecrosis (ON) is a debilitating complication of acute lymphoblastic leukemia (ALL) therapy. While numerous studies have explored its incidence and associated risk factors, investigations using large‐scale cohorts remain important to characterize ON across heterogeneous populations.
Noémie de Villiers   +5 more
wiley   +1 more source

Global Regulatory Perspectives on Clinical Data Management: A Comparative Review of Various Regulatory Agencies

open access: yesNational Board of Examinations Journal of Medical Sciences
Background: Clinical trials are conducted with a set of ethical standards, patient safety measures, and scientific scrutiny. Clinical Data Management Systems have evolved over time, shaped by historical milestones, technological advancement, and ...
Thrupthi D L   +4 more
doaj   +1 more source

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