Results 121 to 130 of about 400,933 (337)

Legislative Delegation and Two Conceptions of the Legislative Power [PDF]

open access: yes, 2006
[Excerpt] The current federal government, with its burgeoning administrative agencies, does not embody what most Americans would recognize as the constitutional doctrine of separation of powers.
Sarvis, Robert C.
core   +1 more source

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Current evidence and insights on single vs. double dose of basiliximab in adult solid organ transplant recipients: A systematic review

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this systematic review was to assess all available clinical data regarding the use of a single dose of basiliximab in solid organ transplantation compared to the standard double dosage, with particular interest in efficacy, safety and cost‐savings.
Alessio Provenzani   +4 more
wiley   +1 more source

Navigating adverse immunostimulation: A practical guide for clinical researchers

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Problem Setting As drug development moves towards more complex products, early clinical development programmes are increasingly hampered by unwanted and/or unexpected activation of the immune system (adverse immune stimulation, AIS). Solution At the Centre for Human Drug Research, we have introduced standardized procedures to make AIS manageable, while
Juliette A. van den Noort   +3 more
wiley   +1 more source

Agencies Obligation to Interpret the Statute [PDF]

open access: yes, 2016
Conventionally, when a statute delegates authority to an agency, courts defer to agency interpretations of that statute. Most agencies and scholars view such deference as a grant of permission to the agency to adopt any reasonable interpretation. That is
Saiger, Aaron J.
core   +2 more sources

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort   +8 more
wiley   +1 more source

Human vs. artificial intelligence: Physicians outperform ChatGPT in real‐world pharmacotherapy counselling

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims To assess the utility of the artificial intelligence (AI) chatbot ChatGPT (openly available version 3.5) in responding to real‐world pharmacotherapeutic queries from healthcare professionals. Methods Three independent and blinded evaluators with different levels of medical expertise and professional experience (beginner, advanced, and expert ...
Benjamin Krichevsky   +9 more
wiley   +1 more source

Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Small‐molecule activin receptor‐like kinase‐2 inhibitor zilurgisertib (INCB000928) is under investigation in a pivotal trial for the treatment of fibrodysplasia ossificans progressiva (FOP), an ultrarare genetic condition. This analysis assessed effects of renal and hepatic impairment on zilurgisertib pharmacokinetics.
Yan‐ou Yang   +5 more
wiley   +1 more source

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