Abstract：
:In the current of era of developing antibacterial agents, including those for unmet medical need, Sponsors are required to submit a robust pre-clinical pharmacokinetic-pharmacodynamic (PK-PD) data package in exchange for limited clinical data. However, the clinical data package also needs to be as robust as possible. The clinical data package needs to include the Phase 1 pharmacokinetic (PK) studies conducted in the target patient populations and special populations. Additionally, PK data need to be collected from all patients enrolled in the pivotal trial(s). Such data are critical to confirm adequate drug exposures relative to non-clinical PK-PD targets for efficacy, explain unexpected clinical failures in individuals or groups of patients, and evaluate exposure-response relationships for safety.
journal_name
Curr Opin Pharmacoljournal_title
Current opinion in pharmacologyauthors
Bhavnani SM,Hammel JPdoi
10.1016/j.coph.2017.09.010subject
Has Abstractpub_date
2017-10-01 00:00:00pages
124-129eissn
1471-4892issn
1471-4973pii
S1471-4892(17)30013-9journal_volume
36pub_type
杂志文章,评审abstract：:Hypothalamic gonadotropin-releasing hormone (GnRH) is a decapeptide that stimulates pituitary synthesis and secretion of gonadotropins and, therefore, gonadal hormones. GnRH antagonists, of which thousands have been formulated, inhibit the hormone from binding to its receptor, inducing a pharmacological hypophysectomy...
journal_title：Current opinion in pharmacology
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abstract：:Opiate drugs, such as morphine, are renowned for their analgesic properties. To date, opioid narcotics represent the largest and most potent class of pain relievers available to treat both acute and chronic pain conditions. The use of opiates, however, is severely limited by several adverse side effects. Upon chronic ...
journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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abstract：:Breast tumor kinase (Brk), also termed PTK6, is known to function in cell-type and context-dependent processes governing normal differentiation. However, in tumors in which Brk is overexpressed, this unusual soluble tyrosine kinase is emerging as a mediator of cancer cell phenotypes, including increased proliferation,...
journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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abstract：:It is increasingly being appreciated that GABAA receptor subtypes, through their specific regional, cellular and subcellular localization, are linked to distinct neuronal circuits and consequently serve distinct functions. GABAA receptor subtype-selective drugs are therefore expected to provide novel pharmacological p...
journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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abstract：:In the last decade, the relationship between drug dosing and treatment efficacy for life-threatening fungal infections has been clarified by application of pharmacodynamic principles to the study of antifungal agents. Similar to antibacterials, antifungal agents can display static or cidal patterns of activity against...
journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2015.04.004
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2012.01.012
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abstract：:Heteromerization of dopamine receptors has been shown for both the D(1)/D(5) and D(2)/D(3)/D(4) receptor families, which couple positively and negatively, respectively, to adenylyl cyclase. The present article reviews data on dopamine heteromers formed by D(3), focusing in particular on associations with their D(2) co...
journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2009.10.001
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2011.01.004
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2011.10.021
更新日期：2012-02-01 00:00:00
abstract：:Metabotropic GABAB receptors clearly modify cognitive performance in preclinical animal models, yet translation to treating human disease has been elusive. Compared to their ionotropic GABAA receptor counterpart GABAB receptors not only regulate postsynaptic excitability but also regulate diverse synaptic inputs by pr...
journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2017.09.012
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abstract：:White adipose tissue (WAT) is a highly dynamic organ that can vary considerably in mass depending on energy balance. Data from recent cross-sectional and prospective clinical studies have revealed a set of mechanisms that link WAT dysfunction to type 2 diabetes. This review focuses on three of the most important patho...
journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2016.02.003
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journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2009.11.007
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journal_title：Current opinion in pharmacology
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2004.01.010
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
doi：10.1016/j.coph.2007.10.013
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abstract：:Somatostatin (SOM) is a regulatory peptide produced throughout the central nervous system and in most major peripheral organs. In humans, the SOM stable analogue octreotide (OCT) is used to treat opioid-resistant pain. In animal models, SOM and OCT are analgesics and SOM released from the peripheral endings of sensory...
journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
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abstract：:The pharmaceutical industry is currently abandoning its antibacterial discovery research efforts. This seems to be part of a cyclical pattern in this therapeutic area. The reasons behind these ongoing cycles of feast and famine are multiple, but most revolve around the perception of market opportunities from the conti...
journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
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journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
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abstract：:Oligonucleotide-based therapeutics have been hailed as 'the next great wave of the biotechnology revolution' starting with antisense oligonucleotides (ASOs) nearly 20 years ago to RNA interference (RNAi) currently. Is RNAi just the latest research tool or does it have real potential as a therapeutic drug modality? As ...
journal_title：Current opinion in pharmacology
pub_type： 杂志文章,评审
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更新日期：2008-06-01 00:00:00
