Abstract：
:Biologics are a primary focus for research and development of new treatments for IBD and other immune disorders. CDER, which is a branch of the FDA, oversees most of the biologics that are being used or tested for IBD, and it regulates nonbiologic medications for IBD. The approval process for most biologics for IBD is similar to the process for nonbiologics. FDA regulation of a new drug or biologic can be divided into three stages: the commercial IND, the NDA, and postmarketing (phase 4) studies. It is unclear if generic versions of biologics can be approved within the current legislation.
journal_name
Gastroenterol Clin North Amjournal_title
Gastroenterology clinics of North Americaauthors
Tremaine WJdoi
10.1016/j.gtc.2006.09.010subject
Has Abstractpub_date
2006-12-01 00:00:00pages
735-41issue
4eissn
0889-8553issn
1558-1942pii
S0889-8553(06)00086-0journal_volume
35pub_type
杂志文章,评审abstract：:Nutritional support can improve the outcome from severe acute pancreatitis in two ways: first by providing the building blocks for tissue repair and recovery, and second, by modulating the inflammatory response and preventing organ failure, both of which are responsible for most of the morbidity and mortality associat...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2007.03.009
更新日期：2007-06-01 00:00:00
abstract：:Swallowed fluticasone and oral viscous budesonide are effective first-line therapies for eosinophilic esophagitis in children. Side effects are minimal without evidence of Cushing syndrome, as seen in treatment with systemic corticosteroids. New studies on alternative delivery systems and different corticosteroids (eg...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章
doi：10.1016/j.gtc.2014.02.008
更新日期：2014-06-01 00:00:00
abstract：:Since the initial discovery of H. pylori by Marshall and Warren 17 years ago, much progress has been made in treating this infection. However, as we enter the millennium, H. pylori infection continues to be one of the most common infections of mankind. In addition, eradication of H. pylori still requires multiple anti...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(05)70137-0
更新日期：2000-09-01 00:00:00
abstract：:The intestine contains major subdivisions of the nervous and immune systems. The lymphoid compartments of the intestine contain functionally distinguishable populations of immunologic cells and are innervated differently. The lamina propria has an extensive network of nerves using the neuropeptides SOM, SP, and VIP. S...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：
更新日期：1991-09-01 00:00:00
abstract：:CD and UC represent a spectrum of chronic IBD that present in protean ways and are accompanied by a variety of systemic sequelae. Sulfasalazine and the newer 5-aminosalicylates are important in the management of mild-to-moderate disease, whereas corticosteroids remain the primary therapy for most patients with moderat...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(05)70058-3
更新日期：1999-06-01 00:00:00
abstract：:Chronic intestinal pseudo-obstruction (CIPO) is a severe form of intestinal dysmotility disorder, characterized by the impairment of gastrointestinal propulsion of the gut content in the absence of fixed occluding lesions. CIPO is a rare disease that can develop in both children and adults. CIPO is classified as prima...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2019.08.005
更新日期：2019-12-01 00:00:00
abstract：:Pediatric patients with inflammatory bowel disease (IBD) stand to benefit from quality improvement (QI) due to the chronic nature of the disease, frequent interaction with the health care system, and exposure to high-risk treatments. The use of QI in health care has led to significant improvements in quality and relia...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2018.07.013
更新日期：2018-12-01 00:00:00
abstract：:The modern management of patients with upper gastrointestinal bleeding includes, in selected patients, the performance of timely multimodal endoscopic hemostasis followed by profound acid suppression. This article discusses the available data on the use of antisecretory regimens in the management of patients with blee...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2010.08.002
更新日期：2010-09-01 00:00:00
abstract：:This article highlights the different dietary approaches that have evolved and become popular over the past few years. Whether these are fads or truly represent important changes in the way peo-ple eat and that ultimately will lead to a lower rate of obesity and improved health is impossible to know. ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2004.12.007
更新日期：2005-03-01 00:00:00
abstract：:HCV in the East is a complex scenario with prevalence rates of 0.5% to as high as 4.7%, and variable distributions of genotypes, with a dominance of genotype 1b in East Asia, genotype 3 in South Asia and South East Asia, and genotype 6 in Indochina. Approvals for the new oral directing antiviral agents (DAAs), in the ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2015.07.007
更新日期：2015-12-01 00:00:00
abstract：:Irritable bowel syndrome (IBS) is a common disorder that has been shown to aggregate in families and to affect multiple generations, but not in a manner consistent with a major Mendelian effect. Relatives of an individual with IBS are 2 to 3 times as likely to have IBS, with both genders being affected. To date, more ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2010.12.011
更新日期：2011-03-01 00:00:00
abstract：:Crohn's disease is not medically (and is rarely surgically) curable. Patients do, however, live a normal life span. The goal of therapy is to optimize the quality of life, minimize disease activity and disease-related complications, and avoid therapeutic toxicity. ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(01)00011-5
更新日期：2002-03-01 00:00:00
abstract：:A persisting reservoir of the Gulf Coast strain of toxigenic V. cholerae O1 in Louisiana and Texas marshes and the shipment of seafood from these areas throughout the United States means that sporadic cases and outbreaks of cholera may occur anywhere in the country for the foreseeable future. Such cases are most likel...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：
更新日期：1993-09-01 00:00:00
abstract：:Gastric cancer (GC) is third leading cause of cancer-related death. Only 28.3% of new GC cases survive more than 5 years. Although incidence has declined in the United States, an increase is estimated for 2016. Risk factors include sex (risk is higher in men), Helicobacter pylori infection, heredity, and lifestyle. GC...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2016.04.002
更新日期：2016-09-01 00:00:00
abstract：:Three (author's standard) or five biopsy specimens (two antral, two corpus, one incisura) as suggested by the Sydney system (original and revised version) [figure: see text] correctly separate infected mucosa from uninfected mucosa. No combination identified correctly the presence of intestinal metaplasia to be consid...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(05)70153-9
更新日期：2000-12-01 00:00:00
abstract：:Diagnostic angiography still plays an essential role in the diagnosis of patients,particularly those with acute lower GI bleeding. Transcatheter therapy appears to be a viable treatment alternative in selected patients with GI bleeding. Many interventionists today believe embolotherapy to be more effective initially a...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章
doi：10.1016/j.gtc.2005.09.001
更新日期：2005-12-01 00:00:00
abstract：:This article defines obesity, ideal body weight, morbid obesity, and indexes of overweight, pointing out some of the difficulties in studies of the epidemiology of morbid obesity. ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章
doi：
更新日期：1987-06-01 00:00:00
abstract：:The past decade has seen the introduction of a number of new potent antimicrobial agents, including broad-spectrum beta-lactam compounds such as the ureidopenicillins, third-generation cephalosporins, carbapenems, and monobactams; combinations of penicillins with inhibitors of beta-lactamase; and the quinolones. Most ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：
更新日期：1992-09-01 00:00:00
abstract：:Constipation is a common clinical problem that comprises a constellation of symptoms that include excessive straining, hard stools, feeling of incomplete evacuation, use of digital maneuvers, or infrequent defecation. Although many conditions, such as metabolic problems, fiber deficiency, anorectal problems, and drugs...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(03)00026-8
更新日期：2003-06-01 00:00:00
abstract：:Endoscopic approaches have revolutionized the palliation of advanced pancreatic cancer. The ideal management consists of a multidisciplinary approach involving surgeons, endoscopists, radiologists, and oncologists. Concurrent advances in the fields of interventional radiology and laparoscopic surgical oncology should ...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2007.04.001
更新日期：2007-06-01 00:00:00
abstract：:The five different viruses that cause human viral hepatitis, A, B, C, D, and E share the unique property of hepatotropism. Identification of the nucleic acid sequences of each of these viruses, coupled with the application of recombinant DNA technology, has resulted in the rapid development of molecular diagnostic tec...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：
更新日期：1994-09-01 00:00:00
abstract：:Overall, fecal markers have been found to be more accurate than serum markers. However, fecal markers are not specific for IBD and may be elevated in a range of organic conditions. Fecal calprotectin and lactoferrin can still differentiate inflammatory disease from functional bowel disorders. Comparison studies have f...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2012.01.007
更新日期：2012-06-01 00:00:00
abstract：:In conclusion, the availability of liver transplantation has dramatically advanced the management of fulminant hepatic failure. A major responsibility of the gastroenterologist/hepatologist involved in the care of patients with liver failure is early decision making regarding likelihood of spontaneous recovery and con...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：
更新日期：1993-06-01 00:00:00
abstract：:Ischemic injury to the gastrointestinal tract can threaten bowel viability with potential catastrophic consequences, including intestinal necrosis and gangrene. The presenting symptoms and signs are relatively nonspecific and diagnosis requires a high index of clinical suspicion. AMI often results from an embolus or t...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(03)00093-1
更新日期：2003-12-01 00:00:00
abstract：:Determining the perioperative risks associated with surgical procedures performed in patients with HIV disease is a difficult and complex task. Because HIV is a contagious, blood-borne pathogen, it threatens the health and well-being of both patient and health care provider. Despite poor early results, there is now co...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(05)70300-9
更新日期：1997-06-01 00:00:00
abstract：:A wide spectrum of gastrointestinal illnesses impairs bone health and can result in bone pain, demineralization, and fracture. This article summarizes current knowledge of the skeletal pathology exhibited in patients with diseases of the liver, biliary tree, pancreas, and bowel. Mechanisms responsible for these syndro...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(05)70016-9
更新日期：1998-06-01 00:00:00
abstract：:Colorectal cancer is a major illness in the Western world. International and migrant studies suggest that environmental causes, notably a fat- and calorie-dense diet (even if adopted in adulthood), are associated with the disease. Case-control studies have not conclusively identified specific etiologic dietary factors...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：
更新日期：1988-12-01 00:00:00
abstract：:The goal of nutritional support in acute pancreatitis is to reduce inflammation, prevent nutritional depletion, correct a negative nitrogen balance, and improve outcomes. Enteral nutrition (EN) in severe acute pancreatitis (SAP) should be preferred to parenteral nutrition. It maintains the integrity of the gut barrier...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2017.10.002
更新日期：2018-03-01 00:00:00
abstract：:Pediatric pancreatitis is an emerging field with an increasing incidence of disease. Management of pediatric pancreatitis is understudied and, therefore, extrapolated from adult studies (although the etiologies are different). There is evidence that feeding is safe in mild acute pancreatitis in children without increa...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/j.gtc.2018.07.003
更新日期：2018-12-01 00:00:00
abstract：:Numerous extraintestinal diseases have been associated with IBD. The role of the gastrointestinal tract in host response to the foreign antigens present in the gut makes the enteric immune system highly susceptible to any external perturbation to the system. Dysregulation of the enteric immune response results in path...
journal_title：Gastroenterology clinics of North America
pub_type： 杂志文章,评审
doi：10.1016/s0889-8553(01)00019-x
更新日期：2002-03-01 00:00:00
