PRODUCT MONOGRAPH
... (pathologic or iatrogenic, such as small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel’s diverticulum). There have been rare reports of obstructive symptoms i ...
... (pathologic or iatrogenic, such as small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel’s diverticulum). There have been rare reports of obstructive symptoms i ...
M7 Step 4 Assessment and control of DNA reactive (mutagenic
... assay. Other types of genotoxicants that are non-mutagenic typically have threshold mechanisms and usually do not pose carcinogenic risk in humans at the level ordinarily present as impurities. Therefore to limit a possible human cancer risk associated with the exposure to potentially mutagenic impu ...
... assay. Other types of genotoxicants that are non-mutagenic typically have threshold mechanisms and usually do not pose carcinogenic risk in humans at the level ordinarily present as impurities. Therefore to limit a possible human cancer risk associated with the exposure to potentially mutagenic impu ...
s sanoFi avent 4 -6' Lt ~,,' 2i
... proprietary brand of Eloxatin as the reference drug product. FDA should require that such applications contain preclinical and/or clinical data neces'sary to show that new platinum compounds created by the addition of an acid to oxaliplalin do not differ significantly in terms of safety and efficac ...
... proprietary brand of Eloxatin as the reference drug product. FDA should require that such applications contain preclinical and/or clinical data neces'sary to show that new platinum compounds created by the addition of an acid to oxaliplalin do not differ significantly in terms of safety and efficac ...
S2 GYNO-PEVARYL® 50, 150 Ovule
... The active substance of GYNO-PEVARYL DEPOT spreads over the vaginal epithelium where it forms a gel layer serving as an econazole depot. The antimycotic effect is thus ensured for several days. A broad spectrum of antimycotic activity has been demonstrated against dermatophytes, yeasts and moulds. E ...
... The active substance of GYNO-PEVARYL DEPOT spreads over the vaginal epithelium where it forms a gel layer serving as an econazole depot. The antimycotic effect is thus ensured for several days. A broad spectrum of antimycotic activity has been demonstrated against dermatophytes, yeasts and moulds. E ...
Frequently Asked Questions about Mifepristone
... No. The FDA approved mifepristone in September 2000, following a 54-month review period, contrasting with a median 15.6 month approval time for all other new molecular entities approved in that year. The approval of mifepristone was not accelerated, nor did mifepristone bypass the standard review pr ...
... No. The FDA approved mifepristone in September 2000, following a 54-month review period, contrasting with a median 15.6 month approval time for all other new molecular entities approved in that year. The approval of mifepristone was not accelerated, nor did mifepristone bypass the standard review pr ...
Pfizer Pipeline as of February 27, 2015
... clinical development. A drug that receives breakthrough designation is eligible for all fast track designation features and an FDA commitment to work closely with the sponsor to ensure an efficient drug development program. More information about the qualifying criteria and features of the Breakthro ...
... clinical development. A drug that receives breakthrough designation is eligible for all fast track designation features and an FDA commitment to work closely with the sponsor to ensure an efficient drug development program. More information about the qualifying criteria and features of the Breakthro ...
2.2.1 The Central Database
... Database contains all the summary data and so is a convenient listing of the available data for children and adults for the chemicals contained in the database. The fields (columns) of the file are described in more detail below. An additional version of the Central Database, labelled “CDforPrint.xl ...
... Database contains all the summary data and so is a convenient listing of the available data for children and adults for the chemicals contained in the database. The fields (columns) of the file are described in more detail below. An additional version of the Central Database, labelled “CDforPrint.xl ...
Doctoral theses MÁRIA TÓTH MD. Semmelweis University
... The administered immunosuppressive agent is a substrate of the CYP3A4 system, so the effect of tofisopam on the CYP3A4 enzyme was investigated in vitro using human recombinant CYP3A4 supersome (Cat. No.: P 202). Benzyoxy-4-(trifluoromethyl)coumarin (BFC) was used as substrate. Tofisoapam was added i ...
... The administered immunosuppressive agent is a substrate of the CYP3A4 system, so the effect of tofisopam on the CYP3A4 enzyme was investigated in vitro using human recombinant CYP3A4 supersome (Cat. No.: P 202). Benzyoxy-4-(trifluoromethyl)coumarin (BFC) was used as substrate. Tofisoapam was added i ...
Tibotec verco application
... in adults. WHO, Geneva, 1991. WHO/GPA/IDS/HCS91.6.) In a costeffectiveness comparative study sponsored by WHO/GPA, it was concluded that the cure rates between different treatment regimens of miconazole, ketoconazole and ketoconazole+acid, were not significantly different from each other, while keto ...
... in adults. WHO, Geneva, 1991. WHO/GPA/IDS/HCS91.6.) In a costeffectiveness comparative study sponsored by WHO/GPA, it was concluded that the cure rates between different treatment regimens of miconazole, ketoconazole and ketoconazole+acid, were not significantly different from each other, while keto ...
Yadav, Virendra Yadav TRANSDERMAL DRUG DELIVERY SYSTEM: REVIEW
... drug in adhesive and others are reservoir and the matrix systems. The market value of TDDS products are increasing with rapid rate, more than 35 products have now been approved for sale in US, and approximately 16 active ingredients are approved globally for use as a TDDS. Transdermal drug delivery ...
... drug in adhesive and others are reservoir and the matrix systems. The market value of TDDS products are increasing with rapid rate, more than 35 products have now been approved for sale in US, and approximately 16 active ingredients are approved globally for use as a TDDS. Transdermal drug delivery ...
Volume 30 • Number 6 • 2013 - Controlled Release Society
... and Südhof elucidated signals to instruct vesicles to release the cargo when required. Using a phrase that could have come from CRS, one press release reported: “timing and location are everything.” Since most of their work was published in the 1970s, 1980s, and 1990s, this material is now standard ...
... and Südhof elucidated signals to instruct vesicles to release the cargo when required. Using a phrase that could have come from CRS, one press release reported: “timing and location are everything.” Since most of their work was published in the 1970s, 1980s, and 1990s, this material is now standard ...
Mechanisms of Drug Interactions
... “Drug-drug interaction” is defined as the pharmacologic or clinical response to the administration of a drug combination that is different from the anticipated effects of the two drugs when given alone.6 Drug-drug interactions may result in adverse drug reactions, decreased therapeutic benefit, or p ...
... “Drug-drug interaction” is defined as the pharmacologic or clinical response to the administration of a drug combination that is different from the anticipated effects of the two drugs when given alone.6 Drug-drug interactions may result in adverse drug reactions, decreased therapeutic benefit, or p ...
of Diabetes
... be: (1) not approved by the U.S. Food and Drug Administration (“FDA”) to be lawfully marketed for the proposed use and not identified in the American Hospital Formulary S e rvice or the United States Pharmacopeia Dispensing Information as appropriate for the proposed use; or (2) subject to review an ...
... be: (1) not approved by the U.S. Food and Drug Administration (“FDA”) to be lawfully marketed for the proposed use and not identified in the American Hospital Formulary S e rvice or the United States Pharmacopeia Dispensing Information as appropriate for the proposed use; or (2) subject to review an ...
Michigan Pharmacy Law Update 2015
... (1) The legislature finds that the use of controlled substances is appropriate in the medical treatment of certain forms of pain, and that efforts to control diversion or improper administration of controlled substances should not interfere with the legitimate, medically recognized use of those cont ...
... (1) The legislature finds that the use of controlled substances is appropriate in the medical treatment of certain forms of pain, and that efforts to control diversion or improper administration of controlled substances should not interfere with the legitimate, medically recognized use of those cont ...
sleor 1 DecembeO, 2006 L.
... C. Environmental Impact In accord with 21 CFR 25.31(a), an Environmental Impact Analysis Statement is not required if there is a determination that Methotrexate Injection is suitable for ANDA status . E. Certification The undersigned certifies that, to the best knowledge and belief of the undersigne ...
... C. Environmental Impact In accord with 21 CFR 25.31(a), an Environmental Impact Analysis Statement is not required if there is a determination that Methotrexate Injection is suitable for ANDA status . E. Certification The undersigned certifies that, to the best knowledge and belief of the undersigne ...
Syllabus of B. Pharma
... Study of plant tissue and ergastic cell inclusion with a view to identify & authenticate powder crude drugs with emphasis on anatomical structures of bark, stem (Monocot, Dicot). ...
... Study of plant tissue and ergastic cell inclusion with a view to identify & authenticate powder crude drugs with emphasis on anatomical structures of bark, stem (Monocot, Dicot). ...
Lansoprazole/C02-039 A Phase 2, Open-Label Multicenter
... Name of Company: TAP Pharmaceutical Products Inc. Name of Finished Product:Prevacid (lansoprazole) Name of Active Ingredient: 2-[[[3-methyl-4-(2,2,2trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole Title of Study: ...
... Name of Company: TAP Pharmaceutical Products Inc. Name of Finished Product:Prevacid (lansoprazole) Name of Active Ingredient: 2-[[[3-methyl-4-(2,2,2trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole Title of Study: ...
QA50_8_Hypersalivationgeneral
... Hyoscine Hydrobromide (see separate Q&A 51 for more detailed information) Three small, short-term studies have investigated the use of transdermal hyoscine patches for the management of hypersalivation in adults and children (2,13,14). Transdermal hyoscine patches offer several advantages over other ...
... Hyoscine Hydrobromide (see separate Q&A 51 for more detailed information) Three small, short-term studies have investigated the use of transdermal hyoscine patches for the management of hypersalivation in adults and children (2,13,14). Transdermal hyoscine patches offer several advantages over other ...
Protocol version 1 05/03/2010 Text S2 PARTICIPATING
... given with milk at each dose. DP was one of the arms in our original treatment trial8 and is currently recommended second-line treatment in PNG for uncomplicated malaria in children. However, there has been the suggestion that cure rates might improve if fat were coadministered with this form of ACT ...
... given with milk at each dose. DP was one of the arms in our original treatment trial8 and is currently recommended second-line treatment in PNG for uncomplicated malaria in children. However, there has been the suggestion that cure rates might improve if fat were coadministered with this form of ACT ...