stability testing of new drug substances and products
Báo cáo y học: "Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development" docx
Ngày tải lên :
09/08/2014, 01:23
... effects from the placebo and new drug must exceed the expected negative effect from the loss of usual care The equipoise principle is replaced here by a new ethical standard of reasonable ‘positive ... benefits and minimize risks to the patient Justice refers to fairness in distributing the benefits and burdens of research The concluding section of the Belmont Report notes a standard of ‘the ... values of the individual arms of the RCT but on their pooled average For example, consider an RCT of a new drug that is believed likely to reduce osteoarthritis pain by 40% versus a clinical standard...
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Analytical profiles of drug substances and excipients vol 27
Ngày tải lên :
14/06/2016, 22:09
... Shervington ~and Reema AI-Tayyem2 (1) Faculty of Pharmacy University of Jordan Amman, Jordan (2) Faculty of Agriculture University of Jordan Amman, Jordan ANALYTICAL PROFILES OF DRUG SUBSTANCES AND EXCIPIENTS ... comprehensive profile of drug substances and pharmaceutical excipients as to their physical and analytical characteristics continues to be an essential feature of drug development The compilation and publication ... explore new and innovative ways to encourage potential authors, and welcome suggestions as to how to get people involved in the writing of analytical profiles Communication from new and established...
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Analytical profiles of drug substances and excipients volume 1
Ngày tải lên :
29/10/2016, 16:01
... gathering together and publishing pertinent information on the physical and chemical properties of various official and new drug substances had its origin with the members of the Section on Pharmaceutical ... cooperative venture to compile and publish AnalyticalB-ofilesof Drug Substances in a series of volumes of which this is the first It is also planned to revise and update these profiles at suitable intervals ... better understanding of drug characteristics, will prove to be useful We welcome new collaborators, and we invite comment and counsel to guide the infant to maturity Klaus Florey xi Table of Contents...
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PERFORMANCE TESTING OF COPPER PERMANENT LINKS AND CHANNEL
Ngày tải lên :
27/10/2013, 17:15
... Performance Testing of Permanent Links and Channels Testing of telecommunications Permanent Links and Channels to determine performance compliance to Class D (using Cat components) and Class E ... Passive Testing With Hand-Held Field Testers There are currently three levels of hand-held field tester: Level 2e – for testing up to Class D Level – for testing up to Class E Level – for testing ... generic PL test head and leads for testing the KRONE FMK and KM8 RJ45 sockets To test HighBand8 installations, use a N2604A-055A HighBand8 on the jumpered fields one end, and the generic RJ45...
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Tài liệu FIELD PERFORMANCE TESTING OF COPPER PERMANENT LINKS AND CHANNEL Class D, Class E, Class EA pdf
Ngày tải lên :
12/12/2013, 12:15
... Performance Testing of Permanent Links and Channels There are distinct areas of cable testing; Certification, Qualification and Verification Certification is the most rigorous of all cable testing and ... Performance Testing V15 060508 Page of 11 Passive Testing With Hand-Held Field Testers There are currently three levels of hand-held field tester: Level 2e – for testing up to Class D Level – for testing ... for PL testing of HighBand8 modules if PL testing is selected on tester N2604A-101 is the Universal Link Probe/Adaptor OMNISCANNER AND C6 FMK & KM8 RJ45 Socket C5 RJ45 Socket HIGHBAND and Ultim8...
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Tài liệu Newfunds, better rules - Overview of new financial rules and funding opportunities 2007-2013 pptx
Ngày tải lên :
18/02/2014, 15:20
... forms of EU funding • practical examples for selected groups of EU funds beneficiaries Getting started… Depending on the type of funding and the profile of your project, there are people and networks ... groups of people NGOs' size as well as the scope of their activities can vary considerably Some NGOs consist of a rather limited number of persons; others may have thousands of members and hundreds ... New funds, better rules Overview of new financial rules and funding opportunities 2007-2013 See this overview of main funding opportunities (pp 3-16) Funding opportunities for you Are you a newcomer...
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Designation: C 110 – 00 - Physical Testing of Quicklime, Hydrated Lime, and Limestone1 doc
Ngày tải lên :
10/07/2014, 23:20
... Practice C 305 13.2.4 The sand shall be a blend of equal parts by weight of graded Ottawa sand and standard 20–30 Ottawa sand The fineness of graded Ottawa sand and standard 20–30 sand may be checked ... of hydrated lime, g, weight of blended Ottawa sand, g, water used, mL, specific gravity of portland cement, specific gravity of hydrated lime, specific gravity of blended Ottawa sand, volume % of ... readings 15.6.2 The reflectometer must first be standardized; this consists of standardization of the bottom of the scale and standardization of the upper part of the scale 15.6.3 Sample pellets should...
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Designation: C 472 – 99 - Physical Testing of Gypsum, Gypsum Plasters and Gypsum Concrete1 ppt
Ngày tải lên :
10/07/2014, 23:20
... weight of standard sand (see 5.2) Mix dry a 100-g sample of the gypsum neat plaster and 300 g of the sand, and then add sufficient water to produce a normal consistency For the quantity of water ... consistency of gypsum concrete have not been determined Weight of plunger Diameter of larger end of plunger Diameter of needle Inside diameter of ring at bottom Inside diameter of ring at top Height of ... rod and plunger to bring the total weight to 50 g for these determinations 8.3.5 Mix gypsum neat plaster with standard sand (see 5.2) in the ratio of 200 g of sand to 100 g of plaster before testing...
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annual report 1999 holderbank by accelerating the construction of new cement plants and kiln lines we aim to strengthen market and cost leadership and enhance environmental efficiency
Ngày tải lên :
27/07/2014, 16:07
... s of Budape st’s Ferihegy Airport offer travelers a great deal of comfort New concrete runways provide more safety for pilots and passengers for landing and take-off HUNGARY At the junction of ... office for all members of the Board of Directors expires on the day of the 2002 General Meeting of Shareholders The Area Managers and the CEO of “Holderbank” Management and Consulting Ltd (HMC) ... comprehensive know-how of our engineering organization score this commitment Also of prime impor- in Switzerland and Canada and the exper- tance is the replacement of fossil fuels with tise of Siam City...
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Advantages and challenges of the spray drying technology for the production of pure drug particles and drug loaded polymeric carriers
Ngày tải lên :
02/09/2015, 13:31
... Advantages and challenges of the spray-drying technology for the PT production of pure drug particles and drug- loaded polymeric carriers SC RI Alejandro Sosnik1* and Katia P Seremeta2,3,4 Laboratory of ... outstanding advantages and challenges of the spray-drying method for the production of pure drug particles and drug- loaded polymeric particles and discusses the potential of this technique and the more ... 5.1 Production of pure drug particles TE 5.2 Production of drug- loaded polymeric carriers AC CE P 5.2.1 Prolonged and targeted drug delivery systems 5.2.2 Polymorphic changes of drugs after spray-drying...
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challenges of biological drug registrationinvietnam and suggesting for improving registration process in a local pharmaceutical company
Ngày tải lên :
25/11/2016, 09:49
... applies for both new drug registration and renewal registrations, effective from Jan 2015 and Jan 2016 respectively All of key existing biological products of HL Pharma will be required renewal submission ... inspection of all components of the pharmaceutical supply chain • Maintenance of a register of available products, and post-marketing surveillance activities, including random sampling of registered ... assessment and evaluation of the quality, safety and efficacy of a medicine, including compliance of manufacturing sites and processes with Good Manufacturing Practice (GMP) standards 14 • Assessment and...
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The importance of project management in small- and medium-sized enterprises (SMEs) for the development of new products through E-collaboration docx
Ngày tải lên :
07/03/2014, 00:20
... management is “the manner of implementation, of expertise, paraphernalia, knowledge and modus operandi to an extensive range of activities for the fulfillment of prerequisite of the specific project” ... al., 2005) and New product development New product development (NPD) is a business process for developing new products for a company, whether it is an upgrade of an existing product or a new concept ... Trend of SMEs (source: Web of Science ® 2010) Figure Trend of new product (source: Web of Science ® 2010) Mohammadjafari et al 11853 Figure Schematic diagram of the literature Department of Design...
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CHALLENGES OF HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF COMBINED DRUG PRODUCTS
Ngày tải lên :
10/12/2016, 13:40
... quantitative control of APIs and drug products and also develop and validate appropriate methods These methods are routinely used by manufacturing companies in process testing and by authorities ... effects of changing the organic–aqueous ratio, the pH of the aqueous phase, the flow rate of the mobile phase and the temperature of the column on the retention time and on the shape of the AMFZ and ... titration 44 iv LIST OF TABLES List of tables Table CMCs of Tween 20 and Tween 60 Table Concentrations of standard APIs 12 Table Chromatographic parameters of the sample peaks...
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MethadoneMaintenance Treatment Promotes Referral and Uptake of HIV Testing and Counselling Services amongst Drug Users and Their Partners
Ngày tải lên :
12/01/2017, 22:10
... history of drug use and inject, drug treatment, drug use relapse, current drug use, and cost of drug use The latter included information about number and type of sex partners, condom use, and percentage ... Patient and provider perspectives on implementation models of HIV counseling and testing for patients with TB The international journal of tuberculosis and lung disease: the official journal of the ... McFarland DA, Kamb ML, Thang NT, et al Utilization of HIV voluntary counseling and testing in Vietnam: an evaluation of years of routine program data for national response AIDS education and prevention:...
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Tài liệu Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement doc
Ngày tải lên :
12/02/2014, 23:20
... women more often than in men.1 Because of potential sex differences in the safety and efficacy of new drugs, it is important to include women and men in all stages of drug development and to analyze ... Estimates of the Number of Men and Women in Clinical Drug Trials Appendix II: Estimates of the Number of Men and Women in Clinical Drug Trials We were able to estimate the number of men and women ... and efficacy of drugs marketed in the United States It does this by overseeing the drug development process, reviewing applications for the marketing of new drugs, and monitoring the safety and...
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Tài liệu HANDBOOK OF THE TREES OF NEW ENGLAND WITH RANGES THROUGHOUT THE UNITED STATES AND CANADA ppt
Ngày tải lên :
13/02/2014, 12:20
... is treated under three heads: Canada and Alaska; New England; south of New England and westward With regard to the distribution outside of New England, the standard authorities have been followed ... Habitat and Range.—In fertile soils; moist woodlands or dry uplands Newfoundland and Nova Scotia, through Quebec and Ontario, to Lake Winnipeg New England,—common, from the vicinity of the seacoast ... Habitat and Range. Low, damp, but not wet woods; dry, sandy soils, high rocky slopes and exposed hilltops, often in scanty soil Newfoundland and Nova Scotia, through the provinces of Quebec and Ontario...
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Tài liệu Developing Culturally and Linguistically Competent Health Education Materials: A Guide for the State of New Jersey ppt
Ngày tải lên :
14/02/2014, 13:20
... MS, New Jersey Department of Health and Senior Services Melissa Vezina, MPH, New Jersey Department of Health and Senior Services Maris Chavenson, Pediatric Asthma Coalition of New Jersey Sandra ... of cultural and linguistic competence: Acknowledgement of the unique issues of biculturalism and bilingual status of both the health care providers and the service populations Incorporation of ... Understand and respond to informed consent forms, 4) Understand medication instructions for themselves and their children, and 5) Be knowledgeable about the health effects of risks, behaviors, and...
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Tài liệu SEXUAL HEALTH EDUCATION A T SCHOOL AND A T HOME: ATTITUDES AND EXPERIENCES OF NEW BRUNSWICK PARENTS pptx
Ngày tải lên :
14/02/2014, 14:20
... too much emphasis on knowing all of the parts of the male and female anatomy The amount of and level of vocabulary is excessive for middle school Theme #2: Quality of teaching Some parents mentioned ... al., 1998) and 95% in rural Nova Scotia (Langille et al., 1996), and suggests that the fears teachers and administrators have of parental and community opposition may reflect the opinions of a small, ... equal numbers of parents reported that SHE should begin in grades K-3, 4-5, and 6-8 (33%, 32%, and 32% respectively) Thus, 65% of parents felt that SHE should begin in elementary school and 97% felt...
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Tài liệu Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment - Subgroup Report on the Lowermoor Water Pollution Incident pdf
Ngày tải lên :
17/02/2014, 10:20
... Cornwall and Isles of Scilly Health Authority and the Lowermoor Liaison Group, which included members of the local community, representatives of South West Water Authority (SWWA) and officers of the ... practitioners and council officers The occurrence of cases of leukaemia in Camelford in 1996, and the investigation of possible causes led to a further round of consultation with the local community and ... Membership of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 245 Appendix 3: Health and other professionals who provided information 247 Appendix 4: Discussion of...
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