• Journal of Astronomy and Space Sciences
• /
• v.28 no.1
• /
• pp.63-70
• /
• 2011

The needs for satellite formation flying are gradually increasing to perform the advanced space missions in remote sensing and observation of the space or Earth. Formation flying in low Earth orbit can perform the scientific missions that cannot be realized with a single spacecraft. One of the various techniques of satellite formation flying is the determination of the precise baselines between the satellites within the formation, which has to be in company with the precision validation. In this paper, the baseline of Gravity Recovery and Climate Experiment (GRACE) A and B was determined with the real global positioning system (GPS) measurements of GRACE satellites. And baseline precision was validated with the batch and sequential processing methods using K/Ka-band ranging system (KBR) biased range measurements. Because the proposed sequential method validate the baseline precision, removing the KBR bias with the epoch difference instead of its estimation, the validating data (KBR biased range) are independent of the data validated (GPS-baseline) and this method can be applied to the real-time precision validation. The result of sequential precision validation was 1.5~3.0 mm which is similar to the batch precision validation.

• Journal of the Korea Institute of Military Science and Technology
• /
• v.13 no.3
• /
• pp.478-485
• /
• 2010

The vaccine is biological pretreatment that improves immunity to a particular disease. We can get immunity from producing antibody with injection antigen which has ability to defense against the disease. The ELISA is the most widely used method to measure antibody titer. We have developed and performed validation of ELISA according to the guideline of KFDA and ICH. In this paper, we have verified ELISA method is an excellent method to measure the titer of anti-PA antibody. We have constructed recombinant protective antigen among anthrax toxins and used as antigen of ELISA. In this validation, we have evaluated precision (repeatability, interlaboratory precision), specificity, linearity(range) and LOD, which are validation articles suggested by guideline. Inter-person precision was replaced with inter-laboratory precision. From the results, we have confirmed high precision in all experiments with CV under 20%.

• Proceedings of the Korean Society of Precision Engineering Conference
• /
• 2007.11a
• /
• pp.163-164
• /
• 2007

• Proceedings of the Korean Society of Precision Engineering Conference
• /
• 2012.10a
• /
• pp.913-914
• /
• 2012

• Proceedings of the Korean Society of Precision Engineering Conference
• /
• 2008.06a
• /
• pp.921-922
• /
• 2008

• Journal of Pharmacopuncture
• /
• v.12 no.4
• /
• pp.33-50
• /
• 2009

Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis. Results : 1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%. 2. Confirming Linearity of Sweet BV in 10-200${\mu}g/m\ell$ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion. 3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance. 4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100${\mu}g/m\ell$ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%). 5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria. 6. Homogeneity of Sweet BV (0.1, 100${\mu}g/m\ell$) at upper, middle, and lower layers all satisfied the accuracy and precision criteria. 7. Stability of Sweet BV (0.1, 100${\mu}g/m\ell$) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion. 8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria. Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV.

• Proceedings of the Korean Society of Precision Engineering Conference
• /
• 2006.10a
• /
• pp.657-658
• /
• 2006

• Journal of Pharmaceutical Investigation
• /
• v.21 no.3
• /
• pp.179-188
• /
• 1991

An HPLC assay method of a drug to be applied to the pharmacokinetic studies of the drug should be completely validated. The validation process for an HPLC assay method in a biological sample was discussed using the data obtained from the development of HPLC method for the simultaneous quantitation of verapamil and norverapamil in human serum. The validation criteria included were specificity, linearity, accuracy, precision, sensitivity, recovery, drug stability, and ruggedness of an assay method.

• Proceedings of the Korean Society of Precision Engineering Conference
• /
• 2007.06a
• /
• pp.791-792
• /
• 2007

• Proceedings of the Korean Society of Precision Engineering Conference
• /
• 2011.06a
• /
• pp.61-62
• /
• 2011