1,721,292 research outputs found
Tissue α-Tocopherol Retention in Male Rats Is Compromised by Feeding Diets Containing Oxidized Frying Oil
No full textSoil Characteristics and Clay Mineralogy of Two Subalpine Forest Spodosols With Clay Accumulation in Taiwan
No full text
Dietary Oxidized Frying Oil Enhances Tissue α-Tocopherol Depletion and Radioisotope Tracer Excretion in Vitamin E-Deficient Rats
No full textCommentary on "accounting for the interim safety monitoring of an adverse event upon termination of a clinical trial"
No full textRethinking statistical approaches to evaluating drug safety
No full text[[abstract]]The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. Materials and Methods: Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to be inadequate. Therefore, based on the concept of proof of safety, the non-inferiority hypothesis is employed to prove that the risk of new drugs does not exceed a pre-specified allowable safety margin, hence proving that a drug has no excessive risk. The results from papers published on Vioxx (R) and Avandia (R) are used to illustrate the difference between the traditional approach for proof of hazard and the non-inferiority approach for proof of safety. Results: The p-values from traditional hypotheses were greater than 0.05, and failed to demonstrate that Vioxx (R) and Avandia (R) are of cardiovascular hazard. However, these results cannot prove that both Vioxx (R) and Avandia (R) are of no cardiovascular risk. On the other hand, the non-inferiority approach can prove that they are of excessive cardiovascular risk. Conclusion: The non-inferiority approach is appropriate to prove the safety of drugs
Clinical Data Management and Case Report Form
No full textClinical Data Management
To provide consistency, accuracy and validity of clinical data in timeliness and cost-effective manner to support of conclusion on efficacy, safety, quality of life and pharmacoeconomic assessment of a pharmaceutical product
Statistical Methods for Clinical Evaluation of Biochip Products
No full textPost HGP (Human Genome Project) Era
Pharmacogentics
Pharmacogenomics
Biochip Products
Target Clinical Trials
Personalized Medicine
Diagnosis and Treatmen
An Introduction to Statistical Evaluation of Drug Products
No full textEvidence from clinical trials must prove that the drug is efficacious –drug is better than no drug
Inference from the sample (patients in trials) to the targeted population (patients in clinical practice)
A decision process for clinical hypotheses based on the trial objectives through statistical testing procedure
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