The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials

scientific article published on 28 August 2007

The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials is …
instance of (P31):
scholarly articleQ13442814

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P6179Dimensions Publication ID1013164393
P356DOI10.1038/SJ.BJC.6603925
P932PMC publication ID2360360
P698PubMed publication ID17726450
P5875ResearchGate publication ID6114782

P2093author name stringJ H M Schellens
S Marchetti
P2860cites workThe price of innovation: new estimates of drug development costsQ28212140
The value of improving the productivity of the drug development process: faster times and better decisionsQ28216310
Can the pharmaceutical industry reduce attrition rates?Q29616077
Combinatorial chemistry in cancer drug development.Q34195838
Preclinical pharmacokinetics: an approach towards safer and efficacious drugsQ34493518
PET for in vivo pharmacokinetic and pharmacodynamic measurementsQ34974991
Clinical trial design for target-based therapyQ34981120
Big physics, small doses: the use of AMS and PET in human microdosing of development drugsQ35075780
Improved early clinical development through human microdosing studiesQ36182266
Minimally invasive pharmacokinetic and pharmacodynamic technologies in hypothesis-testing clinical trials of innovative therapiesQ36466906
Phase I and pharmacologic study of the novel indoloquinone bioreductive alkylating cytotoxic drug E09.Q36751567
Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugsQ48665583
Compressing drug development timelines in oncology using phase '0' trialsQ53208031
Response rates, duration of response, and dose response effects in phase I studies of antineoplasticsQ67899179
Risks in new drug development: approval success rates for investigational drugsQ73924789
Slow start to phase 0 as researchers debate valueQ79760785
Less is more: the human microdosing conceptQ81611248
P433issue5
P407language of work or nameEnglishQ1860
P921main subjectbiomedical investigative techniqueQ66648976
P304page(s)577-581
P577publication date2007-08-28
2007-09-03
P13046publication type of scholarly workreview articleQ7318358
P1433published inBritish Journal of CancerQ326309
P1476titleThe impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
P478volume97

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cites work (P2860)
Q2680179468Ga-Based radiopharmaceuticals: production and application relationship
Q95851906A Review on: Phase '0' Clinical Trials or Exploratory Investigational New Drug
Q94546994A Systematic Review of the Efficacy of Preclinical Models of Lung Cancer Drugs
Q40786849A phase 0 clinical trial of novel candidate extended-release formulations of capecitabine
Q59307351Biocompatibility evaluation of self-assembled micelles prepared from poly(lactide-co-glycolide)-poly(ethylene glycol) diblock copolymers
Q58158341Biomedical Conventions and Regulatory Objectivity
Q30394673Biomedical Imaging in Implantable Drug Delivery Systems
Q56430923Biomedical accelerator mass spectrometry: recent applications in metabolism and pharmacokinetics
Q36205561Characterization of the Canine MHC Class I DLA-88*50101 Peptide Binding Motif as a Prerequisite for Canine T Cell Immunotherapy
Q49280135Comparative oncology: Integrating human and veterinary medicine
Q30406342Consensus recommendations to accelerate clinical trials for neurofibromatosis type 2.
Q27022324Designing Safer and Greener Antibiotics
Q35195500Development of radiotracers for oncology--the interface with pharmacology
Q26752713Diagnostics based on nucleic acid sequence variant profiling: PCR, hybridization, and NGS approaches
Q37922776Discontinued drugs in 2010: cardiovascular drugs
Q57806452Dose translation between laboratory animals and human in preclinical and clinical phases of drug development
Q46711980Enhancing the Alignment of the Preclinical and Clinical Stroke Recovery Research Pipeline: Consensus-Based Core Recommendations From the Stroke Recovery and Rehabilitation Roundtable Translational Working Group
Q45959205Enhancing the alignment of the preclinical and clinical stroke recovery research pipeline: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable translational working group.
Q41083360Good manufacturing practice production of [(68)Ga]Ga-ABY-025 for HER2 specific breast cancer imaging
Q41906250Human microdose evaluation of the novel EP1 receptor antagonist GSK269984A
Q34977050Imaging and cancer: a review
Q46531595In Silico Models for Repeated-Dose Toxicity (RDT): Prediction of the No Observed Adverse Effect Level (NOAEL) and Lowest Observed Adverse Effect Level (LOAEL) for Drugs
Q27000792Lost in translation: animal models and clinical trials in cancer treatment
Q37964571Microdosing studies using accelerated mass spectrometry as exploratory investigational new drug trials
Q37810237Microdosing: Current and The Future
Q39572657Nanoparticle Therapeutics: FDA Approval, Clinical Trials, Regulatory Pathways, and Case Study
Q37152009Neurooncology clinical trial design for targeted therapies: lessons learned from the North American Brain Tumor Consortium.
Q37358492Novel clinical trial designs for innovative therapies
Q36732058Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient
Q38749909Overview of the Use of Murine Models in Leukemia and Lymphoma Research.
Q90360263Pharmacokinetics/Pharmacodynamics models of veterinary antimicrobial agents
Q90211749Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
Q35602195Phase 0 Workshop at the 20th EORTC-NCI-AACR Symposium, Geneva.
Q34941964Phase 0 clinical trials in oncology new drug development
Q37184280Phase 0 clinical trials: conceptions and misconceptions
Q84400479Phase 0 exploratory clinical trials: literature review 2006-2009
Q92867685Pilot Study to Predict Pharmacokinetics of a Therapeutic Gemcitabine Dose From a Microdose
Q36480084Preclinical studies of 5-fluoro-2'-deoxycytidine and tetrahydrouridine in pediatric brain tumors
Q37675456Predictive toxicology approaches for small molecule oncology drugs
Q38810472Process development of a human recombinant diabody expressed in E. coli: engagement of CD99-induced apoptosis for target therapy in Ewing's sarcoma.
Q37435222Prospective of ⁶⁸Ga-radiopharmaceutical development
Q38084156Prospects of Nano–Material in Breast Cancer Management
Q37588057Radiosynthesis and pharmacokinetics of [18F]fluoroethyl bufalin in hepatocellular carcinoma-bearing mice
Q39934032Role of Phase 0 trials in drug development
Q45107461Sodium tungstate modulates ATM function upon DNA damage
Q38088802Systems biology of cyanobacterial secondary metabolite production and its role in drug discovery.
Q39769308The Role of Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Modeling in Drug Discovery and Development
Q38734115The use of human neurons for novel drug discovery in dementia research.
Q26798118Translating clinical trials from human to veterinary oncology and back
Q37992702Using High-Resolution Quadrupole Tof Technology in Dmpk Analyses
Q37289389Why man's best friend, the dog, could also benefit from an anti-HER-2 vaccine

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