source adapted from us food and drug administration guidance for industry bioanalytical method validation
U.S. Food and Drug Administration - Juice HACCP — The Final Rule
... contamination of food, food packaging materials, and food contact surfaces; and (8) Exclusion of pests from the food plant (b) Monitoring The processor shall monitor the conditions and practices ... #F-680–7, August 12 and 27, 1997b FDA, Health hazard evaluation, classiÞcation, and Enforcement Report for recall #F-406–7, May and 7, 1997c FDA Enforcement Reports and HHS press release for recall ... production of safe juices Experts from industry, academia, and the regulatory and consumer sectors presented information on illnesses and the epidemiology of outbreaks arising from contaminated juices;...
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Tài liệu The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense - Department of Defense Interactions with the Food and Drug Administration doc
... recipients of IND drugs, medical monitoring and reporting of the use of such drugs, information about shipment and storage of drugs, disposition of unused IND drugs, and submission of annual and other ... research and development, especially clinical trials, and the FDA regulatory requirements for safety and effectiveness that a new drug must meet before The Acquisition of Drugs and Biologics for CBW ... are essential to the acquisition of drugs and biologicals for CBW defense: licensing drugs and biologics for military uses, especially CBW defense; using drugs and biologics classified by FDA as...
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Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration pptx
... Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological ... Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, 301-436-1441 For foods and food additives, ... from the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Food Safety and Applied Nutrition...
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Báo cáo y học: "Cost of acute renal replacement therapy in the intensive care unit: results from The Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Study" pps
... (41.7% versus 8.3%), Asia (88.9% versus 0%), and Australia (100% versus 0%), whereas nephrologists still played the major role in North America (62.5% versus 25%) and South America (80% versus 20%) ... maximum cost of each domain for CRRT and the minimum cost for IRRT and the maximum cost of each domain for IRRT and minimum cost for CRRT The box represents the 1st and 3rd quartiles of the total ... determined from nursing time and from best available data from each center on hourly costs including all benefits Where data were not available from the hospital itself, we used figures obtained from...
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Tài liệu ITIL® V3 and ASL Sound Guidance for Application Management and Application Development docx
... Netherlands), who distinguishes three forms of IT Management: Business Information Management, Application Management {ASL} and Infrastructure Management Business Information Management and Infrastructure ... of the business organization but focuses on the capacity aspects ‘Demand Management’ is therefore a potentially confusing term because it is often associated with managing IT from a business ... ahead - Business Information Management deals with actively managing, maintaining and supporting the functionality of information systems Business Information Management represents the user organization...
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Comprehensive Cervical Cancer Prevention and Control: Programme Guidance for Countries potx
... Cancer Prevention and Control Programme Guidance for Countries February 2011 Table of Contents Introduction and Purpose of Guidance Guidance for National Strategies and Programming for Cervical Cancer ... prevention and control should involve vaccinating girls and women before sexual debut, and screening women for precancerous lesions and treatment before progression to invasive disease Screening for ... cancer and related morbidity and mortality • overnments must allocate sufficient resources within national budgets and have G appropriate guidelines and service standards before starting and scaling-up...
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Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance pdf
... Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder /guidance/ index.htm ... http://www.fda.gov/cvm /guidance/ published.html U.S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) Office of Regulatory ... pharmaceutical industry address anticipated technical and regulatory issues and questions This guidance is written for a broad industry audience in different organizational units and scientific...
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Guidance for Industry Botanical Drug Products docx
... Guidance for Industry Botanical Drug Products Copies of this Guidance are available from: Division of Drug Information (HFD-240), Office of Training and Communications, Center for Drug Evaluation ... justify imposing a clinical hold Possible grounds for a clinical hold are set forth in § 312.42(b) and discussed in CDER′s guidance for industry on Content and Format of Investigational New Drug ... MARKETING BOTANICAL DRUG PRODUCTS 47 Contains Nonbinding Recommendations Guidance for Industry1 Botanical Drug Products This guidance represents the Food and Drug Administration' s...
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Innovations in Minimizing Waste and Wastewater Effluent from Food and Beverage Processing Operations pdf
... year from landfill Papers and cardboards sent to landfill Purchased cardboard baler and recycled industrial and office paper Cost Savings Diverted 1,800 tons of papers and cardboards per year from ... be used as a resource to motivate, inspire and provide guidance to food and beverage processors in Ontario on identifying and implementing measures to reduce their environmental footprint and ... measures and projects undertaken in Canada, the USA, and internationally They cover a number of sub-sectors including dairy, brewing, meat and seafood processing, dry and baked goods, and other food...
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Báo cáo khoa học: Structure of the substrate complex of thymidine kinase from Ureaplasma urealyticum and investigations of possible drug targets for the enzyme pdf
... pathway for synthesis of DNA precursors Thus, Uu-TK is a gateway for the biosynthesis of dTTP, suggesting that Uu-TK is a good target for drug development Recently the 3D structures of Uu-TK and ... the N-terminus and C-terminus are disordered, and between 6–11 residues depending on the chain are omitted from the model In addition, there is a disordered region between residues 51 and 66 Only ... supported by grants from the Swedish Research Council for the Environment, Agricultural Sciences and Spatial Planning (to L.Y and S.E.), the Swedish Research Council (to H.E and S.E.), and the Swedish...
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Báo cáo khoa học: Molecular basis for substrate recognition and drug ˚ resistance from 1.1 to 1.6 A resolution crystal structures of HIV-1 protease mutants with substrate analogs pptx
... alternate conformations were observed for residues with longer and flexible side chains, such as Lys The number of alternate conformations was in the Comparison of ligand bound and unliganded PR structures ... occupancies of 0.6 and 0.4 and 0.8 and 0.2 for PR–p6pol-PR and PRV82A–p6pol-PR complexes, respectively As the p6pol-PR analog had 11 residues and extended out of the PR-binding pocket, both N- and C-terminal ... complex was caused by the alternate conformations of P1¢ Nle (Fig 6B) Consequently, similar Ki values for PR and PRV82A were observed for both substrate analogs and UIC-94017 (0.3–1.6-fold) and increased...
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báo cáo khoa học: " Overdose prevention for injection drug users: Lessons learned from naloxone training and distribution programs in New York City" pdf
... and performing rescue breathing) and instructions on naloxone administration (intramuscular injection practices, the use of naloxone only with opiate-related overdose and the potential need for ... drug use among opiate users who will view naloxone as an "escape valve" or "safety net" and an opportunity to increase their drug use issue [12,18] For these reasons, naloxone provision to drug users ... establish standards for overdose prevention programs and the use of naloxone by non-medical staff in the case of an overdose [19] This law was unanimously passed in the House and Senate and supported...
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Báo cáo khoa học: "Replication and drug resistant mutation of HIV-1 subtype B'''' (Thailand B) variants isolated from HAART treatment individuals in China" pot
... 94°C for 20 sec, 55°C for 20 sec and 72°C for min, and finally an extension of at 72°C The first-round PCR product (5 μl) and the inner primer set (PRO-1: CAgAgCCAACAgCCCCACCA; HXB2 2147-2166 and ... major coreceptor for primary non-T-cell-line -adapted viruses[10,11] Virus variants use CCR5 co-receptor for entry was R5 phenotype, also referred to as non-syncytium-inducing (NSI) viruses X4 phenotype ... usage of 13 drug resistant variants based the GHOST cell line Interesting, there were 8(61.5%) drug resistant variants were use CCR5 and CXCR4 coreceptor for entry cells (R5X4) In our previous...
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.Dictionary of Food ..Dictionary of Food International Food and Cooking Terms from A to Z Second pptx
... sauce andalouse mayonnaise Andalusian sauce ande andijvie andouille andouille bretonne andouille de Cambrai France A tripe andouille de Cambrai sausage dating from 1767 andouille de campagne andouille ... aurore maigre, sauce Ausbackteig aush aushak Auster Austerpilz Australian barracuda Australian black bream Australian fondant icing Australian oyster australique Austrian pancakes Austro/Malaysian ... calcium, E302 and ortho-palmitoyl, E304 are used in the food industry ascorbic acid Vitamin C used to prevent oxidation and thus browning reactions and colour changes in foods Also used as a flour...
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A study on idiomatic expressions containing words denoting food and drink in English and their Vietnamese equivalents from Cultural Perspective
... containing food and drink” or “idioms of food and drink” for short Food and drink play a very important role in many cultures including English culture and Vietnamese culture Idioms containing food and ... to any kind of food and drink “idioms containing food and drink” or “idioms of food and drink” The idioms of food and drink may contain a certain kind of food or drink as “butter and cheese”, “bad ... containing food and drink from cultural perspective The descriptive method is used to describe the syntactic, semantic and cultural features of idioms containing food and drink in English and Vietnamese...
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A study on idiomatic expressions containing words denoting food and drink in English and their Vietnamese equivalents from Cultural Perspective
... containing food and drink” or “idioms of food and drink” for short Food and drink play a very important role in many cultures including English culture and Vietnamese culture Idioms containing food and ... Collect English and Vietnamese idioms containing food and drink from several sources and then categorize them - Investigate and analyze the syntactic and semantic features of English and Vietnamese ... containing food and drink from cultural perspective The descriptive method is used to describe the syntactic, semantic and cultural features of idioms containing food and drink in English and Vietnamese...
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SELF ASSEMBLY AND DRUG DELIVERY IN AMPHIPHILIC PEPTIDES MICROSCOPIC INSIGHTS FROM COARSE GRAINED SIMULATIONS
... Number of clusters versus time for FmD and FmK (m = 2, and 4) 46 Figure 4.7 Final snapshots for F3Kn (n = 2, 3, 4, 5, and 8) at 2500 ns Phe: yellow, Lys: red Water and ions are not shown for clarity ... nanopipe for the formation of a nanodonut structure.38 Chapter Introduction 1.3.3 Drug and Gene Delivery The hydrophobic core and hydrophilic shell formed by amphiphilic peptides can be used for drug ... biodegradable and biocompatible, important characteristics for ideal drug carriers They can form nano-sized micelles with hydrophobic cores allowing for encapsulation of hydrophobic drugs, and thus provide...
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Báo cáo y học: "Advances in Molecular Diagnosis of HBV Infection and Drug Resistance"
... wild-type/mutant mixtures While fast and accurate, these methods require the use of well-trained technicians and expensive equipment, and have not been optimized for high-throughput use Oligonucleotide Microarrays ... marker and gold standard for HBV viral replication No gold standard among different methodologies Useful marker of infectivity in presence of precore/core promoter Relatively slower to detect drug ... or using animal models [20] Such systems are useful for studying HBV replication, cellular accumulation of covalently closed circular DNA, and for characterizing HBV mutants However, their use...
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E.6 Unit10.B :Food and Drink
... FOOD AND DRINK FOOD DRINK an apple water rice an orange milk fruit a banana meat vegetables SECTION B : FOOD AND DRINK Listen and repeat b) a) d) c) e) g) f) h) Rub out and remember Rub out and ... WHAT THU EAT AND THU DOESN’T EAT FOR LUNCH (BOOK CLOSED) Meat, rice, noodles, milk, fish, vegetables,oranges, bananas Yes No Part 2: Listen and repeat LISTEN AGAIN Phuong :What’s for lunch ? ... There is some (1) and some (2) Phuong : Are there any …(3) ? Thu : No There aren’t any noodles Phuong :Is there any …(4) ? Thu :Yes There is some fruit There are some (5) and some (6) Phuong...
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