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Current opinion in drug discovery & development最新文献

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Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics. 欧洲、加拿大和美国对后续生物制剂市场授权的立法举措。
Current opinion in drug discovery & development Pub Date : 2010-03-01
Ywe J Looper
{"title":"Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics.","authors":"Ywe J Looper","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The formulation and application of legal and regulatory requirements for the market authorization of follow-on versions of biological drugs present challenges. This review discusses relevant regulatory guidelines and legislative initiatives related to market authorization for follow-on biologics in Europe, Canada and the US. The respective positions of these three markets is analyzed with regard to several factors: criteria for the choice of reference products; requirements for the comparability exercise between a candidate follow-on biologic and the selected reference product, with an emphasis on considerations of quality, safety and efficacy data; the interchangeability of a reference product with related follow-on drugs; data exclusivity provisions; and the application of specialized patent enforcement mechanisms to follow-on biologics.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 2","pages":"247-56"},"PeriodicalIF":0.0,"publicationDate":"2010-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28754968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Functional consequences of mTOR inhibition. mTOR抑制的功能后果。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Sucha Sudarsanam, Dale E Johnson
{"title":"Functional consequences of mTOR inhibition.","authors":"Sucha Sudarsanam,&nbsp;Dale E Johnson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>TOR (target of rapamycin) is a serine-threonine protein kinase that is conserved across a diverse range of species from fungi to mammals. The signaling pathway that is anchored by TOR is also conserved across species. In mammals, mTOR integrates growth factor, amino acid, nutrient and energy sensing signals, and thus plays a major role in cell growth and proliferation, protein synthesis and autophagy. As a result of the pivotal role of mTOR in signaling, the aberrant regulation of mTOR has been implicated in several disease processes, including cancer, diabetes, ocular diseases and neurodegenerative disorders, as well as in lifespan extension. More recently, rapamycin (sirolimus) analogs that antagonize the mTOR signaling pathway have been approved for the treatment of several cancers. This review describes some recent advances in the understanding of mTOR signaling, with an emphasis on the functional consequences of mTOR inhibition and therapeutic intervention strategies.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 1","pages":"31-40"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28624575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The biological effects of isoform-specific PI3-kinase inhibition. 特异性pi3激酶抑制的生物学效应。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Nathan T Ihle, Garth Powis
{"title":"The biological effects of isoform-specific PI3-kinase inhibition.","authors":"Nathan T Ihle,&nbsp;Garth Powis","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The four isoforms of class I phosphatidylinositol-3-kinase (PI3K) were originally thought to be redundant in function; however, further research and new technologies have revealed that each subunit has distinct characteristics. In the past decade the number of PI3K inhibitors has increased from a few agents with unacceptable promiscuity and pharmacological properties, to a family of selective agents that are either progressing through experimental development or are in clinical trials. These agents, with two notable exceptions, target multiple members of the PI3K class I isoforms. As data become increasingly available, the concept that inhibiting a single PI3K isoform may offer improved therapeutic benefit, while eliminating the potentially negative effects of pan-isoform inhibition, is driving efforts to develop more specific inhibitors. However, questions remain regarding the best isoform to inhibit for maximum benefit in different pathological settings, and whether increased specificity may lead to a loss in efficacy as a result of isoform redundancy in some settings. This review discusses the current understanding of individual PI3K isoforms in physiology and pathological states, as well as the status of PI3K inhibitors in preclinical and clinical development.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 1","pages":"41-9"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28624576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stereoselective heterocycle synthesis through oxidative carbon-hydrogen bond activation. 通过氧化碳氢键活化合成立体选择性杂环。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Lei Liu, Paul E Floreancig
{"title":"Stereoselective heterocycle synthesis through oxidative carbon-hydrogen bond activation.","authors":"Lei Liu,&nbsp;Paul E Floreancig","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Heterocycles are ubiquitous structures in both drugs and natural products, and efficient methods for their construction are being pursued constantly. Carbon-hydrogen bond activation offers numerous advantages for the synthesis of heterocycles with respect to minimizing the length of synthetic routes and reducing waste. As interest in chiral medicinal leads increases, stereoselective methods for heterocycle synthesis must be developed. The use of carbon-hydrogen bond activation reactions for stereoselective heterocycle synthesis has produced a range of creative transformations that provide a wide array of structural motifs, selected examples of which are described in this review.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 6","pages":"733-47"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29455772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Eliminating pharmaceutical impurities: Recent advances in detection techniques. 消除药物杂质:检测技术的最新进展。
Current opinion in drug discovery & development Pub Date : 2010-01-01
David Q Liu, Mingjiang Sun, Lianming Wu
{"title":"Eliminating pharmaceutical impurities: Recent advances in detection techniques.","authors":"David Q Liu,&nbsp;Mingjiang Sun,&nbsp;Lianming Wu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The elimination of organic impurities to produce highly pure drug substances is an important goal of process chemistry. For the detection of general impurities, hyphenated techniques (eg, liquid chromatography-mass spectrometry [LC-MS]) play a critical role in rapid structural identification (qualitative detection) and in understanding the mechanisms of formation of the impurities, enabling informed decisions to control and eliminate the impurities resulting from the chemical process where possible. Concern regarding genotoxic impurities (GTIs), which must typically be controlled at low parts-per-million limits, continues to increase, and significant advances have been achieved in recent years for the selective and sensitive quantitation (quantitative detection) of such impurities. Conventional detection techniques, such as ultraviolet (UV) detection, are often inadequate for the detection of potentially minute quantities of GTIs; therefore, various advanced MS-based detection strategies, either stand-alone or in conjunction with chemical approaches, are playing an increasing role in this field. The primary aim of this review is to highlight recent advances in qualitative and quantitative detection of impurities at trace levels, with a particular focus on GTIs.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 6","pages":"748-57"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29455773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Synthesis of polyketide natural products and analogs as promising anticancer agents. 聚酮类天然产物及其类似物的合成。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Stephen M Dalby, Ian Paterson
{"title":"Synthesis of polyketide natural products and analogs as promising anticancer agents.","authors":"Stephen M Dalby,&nbsp;Ian Paterson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Recent highlights in the synthesis of polyketide natural products and structural analogs as promising anticancer agents are described, focusing on the halichondrins and eribulin (Eisai), together with recently published research on bryostatin, dictyostatin, spongistatin, peloruside, spirastrellolide, palmerolide, reidispongiolide, spirangien and saliniketals. These examples demonstrate the centrality of bioactive polyketides in current and future anticancer drug discovery, and the increasingly key role of efficient total synthesis in providing a sustainable supply of such compounds for drug development.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 6","pages":"777-94"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29455775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Catalysis in aqueous media for the synthesis of drug-like molecules. 在水介质中催化类药物分子的合成。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Marco Lombardo, Claudio Trombini
{"title":"Catalysis in aqueous media for the synthesis of drug-like molecules.","authors":"Marco Lombardo,&nbsp;Claudio Trombini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The design of straightforward and practical chemical syntheses that satisfy economic and ecological constraints is a major challenge in R&D. Ideally, a sustainable chemical synthesis should be safe, environmentally benign, reasonable in terms of cost, and careful in the use of resources and energy. The capability to develop synthetic strategies that meet these criteria is a priority in the manufacture of fine chemicals and pharmaceuticals, considering that the health and welfare of society increasingly depend on such industries. Among the various objectives to be pursued in sustainable manufacturing, this review focuses on two main goals: (i) the minimization of waste; and (ii) the replacement of toxic and volatile organic solvents with alternative, safer solvents - specifically water. In this context, the development of methods for catalysis in alternative reaction media is recognized as one of the most important approaches in modern chemical production.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 6","pages":"717-32"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29455836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Microreactors for continuous processing – How close to commercial utility? 用于连续处理的微反应器——离商业用途有多近?
Current opinion in drug discovery & development Pub Date : 2010-01-01
Joseph Fortunak, Pat N Confalone, John A Grosso
{"title":"Microreactors for continuous processing – How close to commercial utility?","authors":"Joseph Fortunak,&nbsp;Pat N Confalone,&nbsp;John A Grosso","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Microreactor technology holds great promise for simplifying process chemistry. The design of microreactors inherently simplifies heat transfer and flow. Continuous processing on a commercial scale is also achievable using these reactors, providing significant improvements in efficiency compared with batch processing. Two-phase reactions with liquid-gas and liquid-solid phases present difficulties for microreactor-based processing; however, advances in reactor design are providing some solutions to such challenges. The potential efficiencies provided by microreactors suggest that this technology will be adopted increasingly for widespread commercial applications, particularly following greater investment by companies and further improvements in engineering.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 6","pages":"642-4"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29492061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Immunomodulatory therapies and the risk of opportunistic infections. 免疫调节疗法和机会性感染的风险。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Dale E Johnson, Dennis A Smith, B Kevin Park
{"title":"Immunomodulatory therapies and the risk of opportunistic infections.","authors":"Dale E Johnson,&nbsp;Dennis A Smith,&nbsp;B Kevin Park","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 1","pages":"20-2"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28624573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Factors affecting drug release from liposomes. 影响药物从脂质体释放的因素。
Current opinion in drug discovery & development Pub Date : 2010-01-01
Lars H Lindner, Martin Hossann
{"title":"Factors affecting drug release from liposomes.","authors":"Lars H Lindner,&nbsp;Martin Hossann","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Liposomes are the most widely used nanocarrier systems in medicine. Common strategies for tumor-specific drug delivery using liposomes include the passive accumulation of liposomes that have an increased circulation half-life, which is possible as a result of the leakiness of tumor neovasculature, as well as the active targeting of liposomes using surface-bound ligands. However, such targeting of the nanocarrier is not effective if the encapsulated drug within the liposome is not released at the intended site. Drug release can be influenced by both the membrane composition of the liposome and the choice of drug. In addition to environmental triggers, such as low pH and the presence of particular enzymes, external stimuli such as heat or ultrasound have gained attention in the clinic. This review provides a summary of the various approaches to modifying drug release from liposomes.</p>","PeriodicalId":10809,"journal":{"name":"Current opinion in drug discovery & development","volume":"13 1","pages":"111-23"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28624975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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