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Data from: ALS drug development guidances and trial guidelines: consensus and opportunities for alignment
负责人:
关键词:
guidance;Clinical Trials;Amyotrophic Lateral Sclerosis;drug development;guidelines
DOI:
doi:10.5061/dryad.43qc486
摘要:
of clinical research in ALS and made suggestions over a wide range of drug development topics and served as an educational tool to provide the Agency with additi
Data from: Association between commercial funding of Canadian patient groups and their views about funding of medicines: an observational study
负责人:
关键词:
health technology assessment;Canada;patient organizations;public funding;2012-2018;conflict of interest;pharmaceutical companies
DOI:
doi:10.5061/dryad.th725q8
摘要:
Review (pCODR) make recommendations to Canadian provincial and federal drug plans about funding particular drug-indications. Both utilize input from
Data from: Exploring an alternative explanation for the second phase of viral decay: infection of short-lived cells in a drug-limited compartment
负责人:
关键词:
HIV;Drug exposure;Holocene;None;Viral decay
DOI:
doi:10.5061/dryad.6980c06
摘要:
on can be expected in a compartment with limited drug exposure, thus leading to a slower viral load decay with potential virologic failure and drug
Data from: Developmental expression of drug metabolizing enzymes: impact on disposition in neonates and young children
负责人:
关键词:
Xenobiotic Metabolizing Enzymes;human;Hepatic;Cytochrome P450;Sulfotransferase;Glutathione S-Transferase;Flavin Monooxygenase;UDP Glucuronosyltransferase;Homo Sapiens;ontogeny
DOI:
doi:10.5061/dryad.71pp6
摘要:
Profound changes in drug metabolizing enzyme expression occurs during development that impacts drug efficacy and the risk of adverse events
Data from: Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
负责人:
关键词:
Innovation;pharmaceutical;new drugs;drug launches
DOI:
doi:10.5061/dryad.2263n
摘要:
rall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period. Conclusions: The purported ‘innovation dip’ is an artefact
Data from: A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
负责人:
关键词:
Ethics (see Medical Ethics);Clinical Trials;Protocols & guidelines;1st January 2005 to 31st December 2010
DOI:
doi:10.5061/dryad.013hq
摘要:
/USA without a New Drug Application (NDA) approval in India or South Africa. Conclusions: Despite an increase in clinical trial activities, ther
Data from: Amphotericin B-conjugated polypeptide hydrogels as a novel innovative strategy for fungal infections
负责人:
关键词:
Antifungal activity;Amphotericin B;Poly-peptide hydrogel;Biocompatibility
DOI:
doi:10.5061/dryad.pc602
摘要:
carriers and the corresponding drug deliveries further help elucidate the molecular arrangement in gel phase, indicating the existence of turn features
Data from: Predicting drug-induced liver injury using ensemble learning methods and molecular fingerprints
负责人:
关键词:
DOI:
doi:10.5061/dryad.1k8m6p2
摘要:
Drug-induced liver injury (DILI) is a major safety concern in the drug-development process, and various methods have been proposed to predict
Data from: Rapid quantitative pharmacodynamic imaging by a novel method: theory, simulation testing and proof of principle
负责人:
关键词:
fMRI;pharmacological fMRI;pharmacodynamics;phMRI;drug development;EC50;pharmacokinetic-pharmacodynamic modeling;ED50;neuroimaging;dose-finding
DOI:
doi:10.5061/dryad.s3443
摘要:
imaging reliably estimates EC50 from the simulated data, except when noise overwhelms the drug effect or when the effect occurs only at high doses. In preli
\u2022\tRegulatory requirement for drug development and approval in United States: review
负责人:
关键词:
111701 Aboriginal and Torres Strait Islander Health 111001 Aged Care Nursing 111702 Aged Health Care 110301 Anaesthesiology 110901 Autonomic Nervous System 111501 Basic Pharmacology Biomarkers 110601 Biomechanics 111201 Cancer Cell Biology 111202 Cancer Diagnosis
DOI:
doi:10.6084/m9.figshare.3381274.v1
摘要:
ons of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs), abbreviated new drug applications (ANDAs) and supplemental new drug applications

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