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1 riteria governing regulatory approval of any new drug.
2 ents to facilitate clinical trial design for new drugs.
3 erculosis and provide additional targets for new drugs.
4 asis of their action and permitted design of new drugs.
5 biotics and rapidly evolves activity against new drugs.
6 ry with a view to targeting the pathway with new drugs.
7 knowledge, avenue for the rational design of new drugs.
8 re being recognized as potential targets for new drugs.
9 able impact on the successful development of new drugs.
10 um tuberculosis has prioritized the need for new drugs.
11 nt anthelmintics has prompted the search for new drugs.
12 past few years thanks to the introduction of new drugs.
13 latory mechanisms and support development of new drugs.
14 ed for significant delays in the approval of new drugs.
15 y WHO as a global priority for investment in new drugs.
16 innovative human platform for the testing of new drugs.
17 he bio-medical research and the discovery of new drugs.
18  as a major health issue fuelling demand for new drugs.
19 out dosing information as the only access to new drugs.
20 herapeutic strategies and the development of new drugs.
21            Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abb
22 Beyond continued research and development of new drugs, a focus on drug repurposing could alleviate t
23  long and costly pre-clinical testing in the new drug administration process.
24  Two novel approaches for the development of new drugs against AIDS are summarized each leading to th
25 ategy for drug repositioning, and identified new drugs against the VCP/p97/ERAD pathway in human dise
26 st cells is highly relevant to the design of new drugs aimed at eliminating HIV-1 from infected indiv
27 orm to predict the pharmaceutical effects of new drugs aiming to cure human atherosclerotic diseases.
28 s confidence in their use in Investigational New Drug and New Drug Application filings.
29                       These findings provide new drug and vaccine targets and should help elucidate h
30  more frequent, requiring the development of new drugs and a better understanding of the targeted enz
31          Therefore, during the assessment of new drugs and candidate compounds, ROS generation is an
32 rns in FFS settings than the introduction of new drugs and clinical evidence as well as other factors
33 ion may be addressed, in part, by developing new drugs and devices/procedures to treat hypertension a
34 resistant isolates has prompted the need for new drugs and drug targets.
35        In this Compendium Review, we discuss new drugs and interventional treatments that are undergo
36 s era, including re-evaluating the impact of new drugs and mass drug administration.
37 Promoting Clinical Trials for Development of New Drugs and Medical Devices, Japan Agency for Medical
38                                              New drugs and regimens are being evaluated, and older dr
39                                      Several new drugs and regimens with promising activity against b
40 biotic resistance creates an urgent need for new drugs and targets.
41   Despite the upcoming availability of these new drugs and technologies that will add to existing typ
42  This has generally necessitated a switch to new drugs and the discontinuation of older ones, after w
43 s of disease and contribute to the design of new drugs and therapies.
44  the optimal management of NASH and approved new drugs and treatments, which urgently are needed.
45 tially useful for evaluating the efficacy of new drugs and ultimately for early-stage Alzheimer's dis
46 ion of a single drug, and the development of new drugs and vaccines depends on a better knowledge of
47 gondii biology and help us to better develop new drugs and vaccines.
48  ZIKV infection may be useful for testing of new drugs and vaccines.
49 lems include raising the bar for approval of new drugs and/or pricing of new agents based on the medi
50 VIVC Guidance, only very limited Abbreviated New Drug Application (ANDA) submission for ER oral drug
51 a A challenge study under an Investigational New Drug application (IND).
52 ng completion of phase III studies, eventual new drug application approval rates varied from 0% (zero
53 in their use in Investigational New Drug and New Drug Application filings.
54 ailable through an emergency Investigational New Drug application.
55                                  Abbreviated New Drug Applications (ANDA) data that included manufact
56 , 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug a
57  a series of teleconferences; a review of 46 New Drug Applications from registration studies of uniqu
58 for several LMWH has expired and abbreviated new drug applications have been approved by the Food and
59 ew drug applications and 18% are abbreviated new drug applications, with the largest class of product
60  Drug Administration granted investigational new drug approval for the first phase 2A clinical trial
61 her with a significant drop in the number of new drug approvals raises the need for innovative approa
62        Monitoring of regulatory agencies for new drugs approvals ensures the resource is up-to-date.
63                                     Multiple new drugs are being developed to treat acute myeloid leu
64 e-threatening disease in many countries, and new drugs are clearly needed.
65                                              New drugs are crucially needed for children with cancer.
66 to widespread resistance to these therapies, new drugs are desperately needed to control the TB disea
67            Such a proposal is needed because new drugs are finally being tested in these rare "overla
68  previous analysis, approximately 70% of all new drugs are made up of only ring systems that have bee
69                                              New drugs are needed for each of these diseases.
70  on modification of NAFLD risk factors, many new drugs are now in clinical trials, including trials s
71 e due to developing parasite resistance, and new drugs are required that target the parasite in the l
72                                              New drugs are urgently needed for resistant strains, sho
73                               Development of new drugs as well as investigation of drugs previously u
74 derable complexity to the rational design of new drugs, as it involves the optimization of multiple b
75  Methods: Conducted under an investigational new drug authorization, we prospectively enrolled patien
76           Conducted under an investigational new drug authorization, we prospectively enrolled patien
77 ntal and clinical evidence suggests that the new drugs bedaquiline (B) and pretomanid (Pa), combined
78  check an individual's response to potential new drugs before clinical trials.
79       The legal need for central approval of new drugs before manufacture has been in place continuou
80 erstand overall treatment effectiveness of a new drug being tested.
81 tion and histone modifications, with several new drugs being tested and some already approved by the
82                  Alternative strategies with new drugs, both antiplatelet and anticoagulant agents, a
83 e Food and Drug Administration approval of 2 new drugs, both for the treatment of chronic heart failu
84                      The current decrease of new drugs brought to the market has fostered renewed int
85 last two decades have produced only a single new drug but have represented a renaissance in our under
86 he bulk of its efforts on the development of new drugs, but an alternative approach is to improve the
87  compounds are central to the development of new drugs, but preparing them can be challenging because
88 that would include first the approval of the new drug by the regulatory agencies and second the intro
89                Here, we have tested a potent new drug called imipramine blue (IB), which is a chimeri
90 y cholangitis and PSC in the hope that these new drugs can be used more effectively.
91 distribution characterize VFV as a promising new drug candidate.
92 aving the way for testing its potential as a new drug candidate.
93 enges in malaria treatment, drug resistance, new drug candidates are urgently needed, which should pr
94 erties, Fynomer-Fc fusion proteins represent new drug candidates for the treatment of IL-17A mediated
95    Together, these data will help to develop new drug candidates that could lead to reversal of the F
96 y perceived as a large, untapped resource of new drug candidates, but so far it is unknown whether ta
97 -level that it is possible to avoid TDR to a new drug class for years.
98                       Here, pioneers of this new drug class provide a bench-to-bedside review on prec
99 can promote the development of aptamers as a new drug class to block important oncological processes.
100 s temporarily reduced by the introduction of new drug classes and driven by nonresponding and treatme
101 ed by sharp decreases in the prevalence when new drug classes were introduced.
102                                              New drug classes, eg, inhibitors of vasopeptidases, aldo
103 lity criteria for commercial investigational new drug clinical trial applications submitted to the US
104 d to improved efficacy in clinical trials of new drug combinations, thereby increasing the survival o
105  worsening renal function (WRF) taking these new drugs compared with warfarin.
106 ecommends that in future, for the purpose of new drug compilations, NME is used for a new chemical dr
107 rug space each year and approximately 28% of new drugs contain a new ring system.
108 ug regimens that combine 2 or more expensive new drugs, continuous therapy, and the prolonged disease
109            The identified mechanism offers a new drug delivery platform into the ME.
110                                              New drug delivery systems are highly needed in research
111 argeting molecules other than VEGF and using new drug-delivery systems currently are being developed
112 ods to evaluate the therapeutic potential of new drugs, describe the development and evaluation of em
113 zed as one of the most important targets for new drug design in cancer, cardiovascular, and neurologi
114 ovides an effective pre-filtering method for new drug design.
115 ibility to others, could provide a basis for new drug development and treatment strategies.
116                                              New drug development has also been slow.
117 earch efforts will not only help to generate new drug development ideas and strategies, but also will
118                                  The lack of new drug development in kidney transplantation necessita
119 nt climate of pessimism about the absence of new drug development, it may be instructive to look back
120 stant tuberculosis, and provide an update on new drug development, results of several phase 2 and pha
121 ology and disease and also as a platform for new drug development.
122 e H inhibitors is an attractive strategy for new drug development.
123 ssential tools in the development process of new drugs, diagnostic procedures, and therapies.
124                                We designed a new drug discovery approach that exploits both the stati
125 g and future pathway research may help focus new drug discovery efforts on key novel targets and mech
126 target individual proteins, has emerged as a new drug discovery paradigm.
127 ing starting points for the establishment of new drug discovery programs aimed at cancers harboring o
128 ctions, increasing support has been given to new drug discovery programs.
129 paration of libraries of novel compounds for new drug discovery programs.
130 ified HX, GSN and AAT as potential leads for new drug discovery programs.
131 tion patterns, leading to the development of new drug discovery tools.
132 crobial drug, host, and context; parallel to new drug discovery, broad ranging, multidisciplinary res
133 subject to animal testing upon adaptation in new drug discovery.
134 These findings suggest a continuous need for new drugs, early detection/treatment of HIV-1 infection.
135 uation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1,
136 harmacodynamic properties, with more than 40 new drugs entering the market in the last 15 years.
137 ome at a rapid pace, especially with several new drugs entering the market in the last few years.
138  researchers of his day, was given access to new drug entities, and the method he used to discover th
139 come a key element in the development of any new drug entity.
140 rd, informed consent, and an Investigational New Drug Exemption, six healthy volunteers and 10 patien
141                               Many promising new drugs fail in the early stages of clinical trials.
142                   Dimethyl fumarate (DMF), a new drug for multiple sclerosis (MS) treatment, acts aga
143 nterventions in chronic heart failure and of new drugs for acute heart failure.
144 g allergic reactions, representing potential new drugs for allergies.
145 ry tract microbiomes, and the development of new drugs for BV treatment.
146 timally utilize existing drugs or to develop new drugs for CNS disorders.
147 questions in lung biology and for developing new drugs for disorders such as cystic fibrosis and asth
148 these models a valuable tool for identifying new drugs for multifunctional drug therapy against acute
149              It is an urgent need to develop new drugs for Mycobacterium tuberculosis (Mtb), and the
150                           The development of new drugs for the treatment of depression is strategic t
151                                              New drugs for the treatment of diabetes, glucagon-like p
152 y the US Food and Drug Administration of two new drugs for the treatment of idiopathic pulmonary fibr
153                                              New drugs for the treatment of tuberculosis (TB) are bec
154 e peptide-1 receptor agonists (GLP-1RAs) are new drugs for the treatment of type 2 diabetes.
155 r hybrid compounds show promise as potential new drugs for treating cerebral malaria.
156 st response, should lead to the discovery of new drugs for treating infections.
157                       We aimed to evaluate a new drug-free fully bioresorbable lactic acid-based scaf
158 uture research may show benefit to patients, new drugs from older classes may show superior effective
159 ario Cancer Registry and Cancer Care Ontario New Drug Funding Program (CCO NDFP).
160 nships from DrugBank, and use it to discover new drug-gene relationships for both knowledge bases.
161              The exploratory investigational new drug guidance describes early phase 1 exploratory ap
162         Despite >100 clinical trials, only 2 new drugs had been approved by the US Food and Drug Admi
163                     The cost of developing a new drug has increased sharply over the past years.
164 m treatment of bipolar disorder, but several new drugs have been assessed for this indication.
165 ost immunity towards tumor killing, and many new drugs have been developed to target this interaction
166 onduct and feasibility of phase 3 trials for new drugs have been proposed.
167        However, discovery and development of new drugs have been restricted because of differences in
168 re explored through case studies showing why new drugs have different periods of exclusivity in diffe
169                                              New drugs have not been forthcoming and are not likely t
170  need for effective IPF therapy, a number of new drugs have recently been, or are now being, evaluate
171 more than a decade, in the past 4 years five new drugs have shown efficacy with improvements in overa
172 HR ligands should be considered as potential new drugs in dermatology.
173 viding more rapid detection of resistance to new drugs in experimental regimens.
174 isons may provide insight into the effect of new drugs in patients with cytogenetic abnormalities.
175          In addition, there are insufficient new drugs in the pipeline to anticipate the appearance o
176 be used as a control arm in future trials of new drugs in this setting.
177                    The key advantages of the new drug include a remarkably fast accumulation time (di
178                                              New drugs including N-acetylcysteine, bortezomib, recomb
179 ing studied clinically under investigational new drug (IND) applications submitted to the U.S. Food a
180 FMT must possess an approved investigational new drug (IND) permit to administer FMT for the purpose
181  the meetings, there were no investigational new drugs (INDs) in place for the candidate MCMs.
182 cal platform to help analyse the activity of new drugs (Innovative Therapy for Children with Cancer P
183 is in DA neuron VMAT vesicles and suggests a new drug interaction in which amphetamine induces CYAM d
184 y, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy,
185 nimal models and facilitating progression of new drugs into clinical trials.
186 ry process will speed up the introduction of new drugs into clinics.
187                Crucially this highlights how new drugs, introduced to circumvent known resistance mec
188 ll probably include add-on trials in which a new drug is combined with an intervention with establish
189                   Designation of an NTE as a new drug is significant, as it may confer regulatory exc
190 odels, upon which preclinical development of new drugs is based, can only replicate host conditions w
191                              This quintet of new drugs is likely to reshape the therapeutic landscape
192  and the potential of this intermediate as a new drug lead.
193 ompound can often determine the success of a new drug lead.
194 ibacterial resistance and the development of new drugs lead to a continuous change of guidelines for
195 er cells can identify thousands of potential new drug-leads.
196  screening campaign was carried out, seeking new drug-like compounds able to rescue DeltaF508-CFTR th
197                        The spiraling cost of new drugs mandates a fundamentally different approach to
198 ife solutes is proposed, taking cubosomes as new drug nanocarriers of potential interest for drug del
199                 To aid in the development of new drug nanocarriers, we propose a novel plasmonic nano
200 nd 3,4-methylenedioxypyrovalerone (MDPV) are new drugs of abuse that have gained worldwide popularity
201                           The development of new drugs offers clinicians several choices to treat pat
202 hypothetical treatments that were labeled as new drug, old drug, or no drug.
203 ess during infection should help in devising new drugs or vaccines against hookworms.
204 dification of existing drugs, development of new drugs, or combination of novel drug delivery agents
205 perimentally measured the interaction of 123 new drug pairs, as a prospective validation set for our
206                               In response to new drugs, pathogenic bacteria rapidly develop resistanc
207 formulation screening as a critical step for new drug product development, and how utilizing hydropho
208 BAT under an expanded-access Investigational New Drug program.
209 losis have focused on development of several new drug regimens and their evaluation in clinical trial
210                           The development of new drug regimens that allow rapid, sterilizing treatmen
211 design of green catalysts and the pursuit of new drug regimens.
212  framework, PUDTI, is then designed to infer new drug repositioning candidates by integrating NDTISE,
213                             The emergence of new drug resistance mutations declined dramatically from
214 accelerate eradication of infection, prevent new drug resistance, and prevent permanent lung injury.
215 ith fewer long-term liabilities, efficacy on new drug-resistant HIV-1 strains, and less frequent dosi
216 menced treatment for around 17% of estimated new drug-resistant patients.
217                                          All new drug-resistant viruses arise during intracellular re
218 ystem, identified about 58% of the estimated new drug-sensitive (DS) TB patients in 2016.
219              As a result, clinical trials of new drugs sometimes fail even after considerable success
220 ons were established to meet investigational new drug submission and institutional review board appro
221 enic compounds that could eventually lead to new drugs suitable for the treatment of some types of tu
222 y, these findings also suggest nNOSbeta as a new drug target and provide a new conceptual framework f
223         Hence, T-channels may be a promising new drug target for different cognitive deficits.
224              Our study identifies Vps34 as a new drug target for insulin resistance in Type-2 diabete
225                Together, CD30 is a promising new drug target for patients with CD30(+) advanced SM.
226 an pulmonary vascular homeostasis suggests a new drug target for the pharmacological management of pu
227 t-sensing receptor and represents a possible new drug target in metabolic disorders.
228  brain, as well as for identifying potential new drug target pathways.
229  in the N-terminal region of NHR trimer as a new drug target, and then we designed several short arti
230 se virus families and illuminate a potential new drug target.
231 grating heterogeneous information to predict new drug-target interactions and repurpose existing drug
232 ult, computational methods for predictioning new drug-target interactions have gained a tremendous in
233                                Prediction of new drug-target interactions is critically important as
234  and (4) building DNILMF model and smoothing new drug/target predictions based on their neighbors.
235 cedure consists of four steps: (1) inferring new drug/target profiles and constructing profile kernel
236 tions of this channel and the development of new drugs targeting cellular proton transport.
237  modulation, and to support the discovery of new drugs targeting NRs.
238  a molecular basis for clinically developing new drugs targeting these gene mutations for GIST therap
239 high-risk women and may lead to discovery of new drug targets against associated adverse pregnancy ou
240 nction, which is significant for identifying new drug targets and developing new therapeutic approach
241                                              New drug targets and lead compounds exempt from cross-re
242 ly needed as more relevant tools to identify new drug targets and therapies.
243 drome (MetS) has led to the realisation that new drug targets are needed to either reduce obesity or
244 al biology in PD risk, and suggest potential new drug targets for PD.
245 lasmic gelsolin signaling pathway, providing new drug targets for the treatment of demyelination dise
246 eria bancrofti, and Brugia malayi available, new drug targets have been identified.
247 refore, there is an imperative to search for new drug targets in S. haematobium and other schistosome
248  rapid development of HIV-1 drug resistance, new drug targets need to be explored continuously.
249                    These key drivers provide new drug targets to improve the sensitivity of cancer th
250 L1-interacting molecules that could serve as new drug targets to treat APOL1-associated renal disease
251  be used to improve existing drugs, identify new drug targets, and understand the basis of drug resis
252 anscriptional regulators and have emerged as new drug targets, but their functional distinction has r
253 esis represents a useful strategy to uncover new drug targets.
254 f cancer diagnosis and the identification of new drug targets.
255  subgroups and lead to the identification of new drug targets.
256                           The development of new drugs that are designed to be more selective inducer
257 rder are limited in their effectiveness, and new drugs that can easily be translated into the clinic
258  therefore has been proposed as a target for new drugs that control KRAS transcription, which require
259  effective drugs, and to continue to develop new drugs that do not cause these side-effects and have
260 urn will have a greater chance of validating new drugs that may be effective for the disease.
261                                   Developing new drugs that specifically target SUMOylation offers a
262 derable progress has been made in developing new drugs that target additional MC/B mediators or recep
263                   Next to the development of new drugs, the strategy of combining agents with synergi
264 ort translational pharmacological studies of new drug therapies and provide evidence for engagement o
265 of resistance and the restricted pipeline of new drug therapies pose considerable risks to global hea
266 10 fusion protein as a long-needed potential new drug to stop persistent pain states.
267     Thus, arglabin may represent a promising new drug to treat inflammation and atherosclerosis.
268 is currently in preclinical development as a new drug to treat lung infections caused by Gram-negativ
269 optosis may contribute to the development of new drug to treat lymphomas and oncovirus infections.
270 a validated target for the identification of new drugs to be added to the combination regimen recentl
271 esis and pave the way for the development of new drugs to hamper the clinical effects of the disease.
272 g marketing approval and the availability of new drugs to patients.
273 bsequently may facilitate the development of new drugs to silence the oncogenic effect of SET/TAF-Ibe
274  these hurdles and, potentially, to bringing new drugs to the clinic more quickly and efficiently.
275 noketone derivatives as means of identifying new drugs to treat Chagas disease in the acute phase wit
276                             In 2014, several new drugs to treat hepatitic C virus received US Food an
277  compliance or tolerance of this medication, new drugs to treat hypertension are urgently needed.
278  resistance, necessitates the development of new drugs to treat influenza infections.
279                  There is an urgent need for new drugs to treat malaria, with broad therapeutic poten
280      However, as we acknowledge the need for new drugs to treat these desperately ill patients, there
281 tly increased only in the presence of recent new drug treatment with antiepileptics or allopurinol, r
282               With a clear clinical need for new drug treatments for HAT that address both the hemoly
283                                              New drug treatments, clinical trials, and standards of q
284 ilitating the mechanism-based development of new drug treatments.
285  complexes with proteins that are targets of new drugs under development defines the future of epigen
286     SJS/TEN mostly manifest as a reaction to new drug use, but little is known about their incidence
287 nhibitors that might be further optimized to new drugs useful for the treatment of Parkinson's diseas
288 that an accelerated approval of a particular new drug using an intermediate end point, such as MRD, w
289 la melanogaster may enhance the detection of new drugs via modifier or 'enhancer/suppressor' screens,
290  arm, as expected with the introduction of a new drug vs remaining on a well-tolerated drug.
291              In a large clinical trial, this new drug was found to reduce hospitalization and mortali
292 fter a gap of more than 10 years in which no new drugs were approved.
293  development for testing the interactions of new drugs with DNA before the drug efficacy can be asses
294 dynamics can be a powerful tool in designing new drugs with engineered binding/unbinding kinetics.
295 rgoing a renaissance with the expectation of new drugs with enhanced levels of efficacy and safety.
296                                              New drugs with novel mechanisms of action, such as cardi
297  only be resolved through the development of new drugs with novel mechanisms of action.
298 herefore represent opportunities to discover new drugs with unique mechanisms of action.
299                    The incorporation of such new drugs within a CHOP backbone is under investigation
300 fected persons in the United States with the new drugs would cost an additional $65 billion in the ne

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