Essentials of Clinical Research - part 4 potx

... promotion. JAMA. Nov 14, 1990; 2 64( 18): 240 9– 241 5. 40 . 21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997 (Modernization Act) In: Department of Health and Human ... decrease in mortality was most marked in the first 24 months of fol- low-up, with an average follow-up period of 40 months. Therefore, only long-term compliance wit...

Ngày tải lên: 14/08/2014, 11:20

... and paucity of fat cells d Histologic section during chronic phase of CML. Naphthol AS-D chloro- acetate esterase reaction shows an ex- treme increase in neutrophilic granulo- cytopoiesis 148 Chapter ... BCR-ABL translocation, the demonstra- tion of low or even negative leukocyte alkaline phosphatase (LAP, see p. 13) w as of key impor- tance. Today the diagnosis is established by det...

Ngày tải lên: 10/08/2014, 08:20

... Document Not part of the CTD CTD Module 2 Module 1 Regional Administrative Information 1 1.1 Submission T of C Module 3 Quality 3 3.1 T of C Module 4 Nonclinical Study Reports 4 4.1 T of C Module 5 Clinical Study ... follow-up angiogram per- formed at least 4 months after the index intervention. Otherwise, 4. If there is objective evidence of recurrent ischemia between 14...

Ngày tải lên: 14/08/2014, 07:20

... time. Essentials of Clinical Research Part I This Part addresses traditional clinical research, beginning with the history of the development of clinical research, to traditional clinical research ... flip of a coin determined which group received the study drug. 7 Further analysis of the tuberculosis streptomycin study of 1 948 is regarded as the beginning...

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... 1 .4% 1% 97,959 23,223 9,757 3,1 04 3% 2.7% 2 .4% 2.1% 1.5% 64, 673 15,339 6 ,44 7 2,053 5% 4. 5% 4. 0% 3.5% 2.5% 38, 044 9,032 3,800 1,212 10% 9% 8% 7% 5% 18,072 4, 302 1,815 581 20% 18% 16% 14% ... fre- quently, there is confusion about the difference between clinical research and clinical trials. A clinical trial is one type of clinical research. A clinical trial...

Ngày tải lên: 14/08/2014, 11:20

... Accessed October 4. 38. Abenhaim L. Lessons from the withdrawal of rofecoxib: France has policy for overall assess- ment of public health impact of new drugs. BMJ. Dec 4, 20 04; 329( 747 8):1 342 . 39. FDA. ... use Short-term use of drug Narrowly-specified or restricted population PE-POSTMARKETING Large population of users Long study period Off-label use; new indications Long- t...

Ngày tải lên: 14/08/2014, 11:20

... monitoring of clinical tri- als. Lancet. Dec 4, 1999; 3 54( 91 94) :1983–1988. 11. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of ... in the meta-analysis Raw data Treatment A PLACEBO Study Total no. of patients No. dead No. alive Total no. of patients No. dead No. alive 1 615 49 566 6 24 67 557 2 75...

Ngày tải lên: 14/08/2014, 11:20

... Nature. Nov 23 2006; 44 4(7118) :44 4 45 4. 3. Lewontin RC. The interaction of selection and linkage. I. General considerations; heterotic models. Genetics. 19 64; 49 :49 –67. 4. Ardlie K, Kruglyak ... Bull. 1979; 86:638– 641 . 13. Smith ML. Publication Bias and Meta-Analysis. Eval Educ. 1980; 4: 22– 24. 14. Glass G. Meta-Analysis at 25. 2000. Fig. 10 .4 Parachutes reduce the ri...

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... 173 (4) :46 4; author reply 46 4 46 5. 46 . Suissa S. Immortal time bias in observational studies of drug effects. Pharmacoepidemiol Drug Saf. Mar 2007; 16(3): 241 – 249 . 47 . Suissa S. Effectiveness of ... 2. Lenfant C. Shattuck lecture clinical research to clinical practice–lost in translation? N Engl J Med 2003; 349 :868– 74. 3. Kiefe CI, Sales A. A state -of- the-art con...

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... 3, 940 4, 000 Marginal probability of DVT = 60 /4, 000 = 0.0150 or 1.50% On HRT = 1,700 /4, 000 = 0 .42 50 or 42 .50% Conditional probability of DVT given you are on HRT = 33/1,700 = 0.01 94 or 1. 94% Conditional ... number of events not occurring (i.e. non events, or p/p-1,). So if blood type O occurs in 42 % of people, the odds of someone having a blood type of O are 0 ....

Ngày tải lên: 14/08/2014, 11:20