scholarly journals USFDA-GUIDELINE BASED VALIDATION OF TESTING METHOD FOR RIFAMPICIN IN INDONESIAN SERUM SPECIMEN

2010 ◽  
Vol 10 (1) ◽  
pp. 138-141
Author(s):  
Tri Joko Raharjo ◽  
Tri Wahyudi ◽  
Sismindari Sismindari
Keyword(s):  
Drug Target ◽  
Dynamic Range ◽  
Research Report ◽  
Serum Specimen ◽  
Limit Of Quantification ◽  
Long Term Stability ◽  
Testing Method ◽  
The People ◽  
Bioequivalence Testing

Regarding a new regulation from Indonesia FDA (Badan POM-RI), all new non patent drugs should show bioequivalence with the originator drug prior to registration. Bioequivalence testing (BE-testing) has to be performed to the people that represented of population to which the drug to be administrated. BE testing need a valid bio-analytical method for certain drug target and group of population. This research report specific validation of bio-analysis of Rifampicin in Indonesian serum specimen in order to be used for BE testing. The extraction was performed using acetonitrile while the chromatographic separation was accomplished on a RP 18 column (250 × 4.6 mm i.d., 5 µm), with a mobile phase composed of KH2PO4 10 mM-Acetonitrile (40:60, v/v) and UV detection was set at 333 nm. The method shown specificity compared to blank serum specimen with retention time of rifampicin at 2.1 min. Lower limit of quantification (LLOQ) was 0.06 µg/mL with dynamic range up to 20 µg/mL (R>0.990). Precision of the method was very good with coefficient of variance (CV) 0.58; 7.40 and 5.56% for concentration at 0.06, 5, 15 µg/mL, respectively. Accuracies of the method were 3.22; 1.94; 1.90% for concentration 0.06, 5 and 15 µg/mL respectively. The average recoveries were 97.82, 95.50 and 97.31% for concentration of rifampicin 1, 5 and 5 µg/mL, respectively. The method was also shown reliable result on stability test on freezing-thawing, short-term and long-term stability as well as post preparation stability. Validation result shown that the method was ready to be used for Rifampicin BE testing with Indonesian subject.   Keywords: Rifampicin, Validation, USFDA-Guideline

scholarly journals An Improved Difference Temperature Compensation Method for MEMS Resonant Accelerometers

Micromachines ◽  
2021 ◽  
Vol 12 (9) ◽  
pp. 1022
Author(s):  
Pengcheng Cai ◽  
Xingyin Xiong ◽  
Kunfeng Wang ◽  
Jiawei Wang ◽  
Xudong Zou
Keyword(s):  
Temperature Compensation ◽  
Dynamic Range ◽  
Compensation Method ◽  
Frequency Drift ◽  
Long Term Stability ◽  
Frequency Output ◽  
Resonant Accelerometer ◽  
Difference Temperature ◽  
Higher Sensitivity

Resonant accelerometers are promising because of their wide dynamic range and long-term stability. With quasi-digital frequency output, the outputs of resonant accelerometers are less vulnerable to the noise from circuits and ambience. Differential structure is usually adopted in a resonant accelerometer to achieve higher sensitivity to acceleration and to reduce common noise at the same time. Ideally, a resonant accelerometer is only sensitive to external acceleration. However, temperature has a great impact on resonant accelerometers, causing unexcepted frequency drift. In order to cancel out the frequency drift caused by temperature change, an improved temperature compensation method for differential vibrating accelerometers without additional temperature sensors is presented in this paper. Experiment results demonstrate that the temperature sensitivity of the prototype sensor is reduced from 43.16 ppm/°C to 0.83 ppm/°C within the temperature range of −10 °C to 70 °C using the proposed method.

The Flexible Microtube Plasma as Post-Ionization Source for Cholesterol in nano-Electrospray Mass Spectrometry

2021 ◽  
Author(s):  
Daniel Foest ◽  
Alexander Knodel ◽  
Robert Ahrends ◽  
Cristina Coman ◽  
Joachim Franzke ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Dynamic Range ◽  
Standard Addition ◽  
Polar Compounds ◽  
Ionization Mass ◽  
Ionization Source ◽  
Long Term Stability ◽  
Novel Approach

Cholesterol serves as a biomarker in clinical- and life-sciences. The determination of abnormal levels can indicate several types of human diseases. However, the low polarity of free cholesterol makes it hardly accessible by (nano) electrospray ionization mass spectrometry (nESI-MS). As novel approach, the flexible microtube plasma (FμTP) for post-ionization allows the determination of low-polar compounds like cholesterol in combination with nESI-MS. Focusing on the analytical performance, the activated post-ionization leads to an increased cholesterol signal by a factor of 22. The repeatability and long-term stability could be successful evaluated by using a complex liver extract. Via the method of standard addition, a linear dynamic range of 1.7 orders of magnitude, a minimum detectability of 3.71 mg/L and a high accuracy (deviation: − 8.11 %) is demonstrated proofing the FμTP-nESI-MS as an excellent approach for a derivatization-free determination of cholesterol without the necessity of high-resolution Orbitrap devices or enhanced MS acquisition-methods.

Stability and Change in Emotional Intelligence: Exploring the Transition to Young Adulthood

2005 ◽  
Vol 26 (2) ◽  
pp. 100-106 ◽  
Author(s):  
James D.A. Parker ◽  
Donald H. Saklofske ◽  
Laura M. Wood ◽  
Jennifer M. Eastabrook ◽  
Robyn N. Taylor
Keyword(s):  
High School ◽  
Emotional Intelligence ◽  
Postsecondary Education ◽  
Life Transition ◽  
Full Time ◽  
Major Life ◽  
Long Term Stability ◽  
Time Period ◽  
Transition From High School

Abstract. The concept of emotional intelligence (EI) has attracted growing interest from researchers working in various fields. The present study examined the long-term stability (32 months) of EI-related abilities over the course of a major life transition (the transition from high school to university). During the first week of full-time study, a large group of undergraduates completed the EQ-i:Short; 32 months later a random subset of these students (N = 238), who had started their postsecondary education within 24 months of graduating from high school, completed the measures for a second time. The study found EI scores to be relatively stable over the 32-month time period. EI scores were also found to be significantly higher at Time 2; the overall pattern of change in EI-levels was more than can be attributed to the increased age of the participants.

Multi-Center Calibration of the Second Reference Material for Thromboplastin, Rabbit, Plain, Coded CRM 149R

1991 ◽  
Vol 65 (03) ◽  
pp. 263-267 ◽  
Author(s):  
A M H P van den Besselaar ◽  
R M Bertina
Keyword(s):  
Reference Material ◽  
Standard Error ◽  
Standard Errors ◽  
Sensitivity Index ◽  
Long Term Stability ◽  
Significant Bias ◽  
The Mean ◽  
The Relationship ◽  
International Sensitivity Index

SummaryIn a collaborative trial of eleven laboratories which was performed mainly within the framework of the European Community Bureau of Reference (BCR), a second reference material for thromboplastin, rabbit, plain, was calibrated against its predecessor RBT/79. This second reference material (coded CRM 149R) has a mean International Sensitivity Index (ISI) of 1.343 with a standard error of the mean of 0.035. The standard error of the ISI was determined by combination of the standard errors of the ISI of RBT/79 and the slope of the calibration line in this trial.The BCR reference material for thromboplastin, human, plain (coded BCT/099) was also included in this trial for assessment of the long-term stability of the relationship with RBT/79. The results indicated that this relationship has not changed over a period of 8 years. The interlaboratory variation of the slope of the relationship between CRM 149R and RBT/79 was significantly lower than the variation of the slope of the relationship between BCT/099 and RBT/79. In addition to the manual technique, a semi-automatic coagulometer according to Schnitger & Gross was used to determine prothrombin times with CRM 149R. The mean ISI of CRM 149R was not affected by replacement of the manual technique by this particular coagulometer.Two lyophilized plasmas were included in this trial. The mean slope of relationship between RBT/79 and CRM 149R based on the two lyophilized plasmas was the same as the corresponding slope based on fresh plasmas. Tlowever, the mean slope of relationship between RBT/79 and BCT/099 based on the two lyophilized plasmas was 4.9% higher than the mean slope based on fresh plasmas. Thus, the use of these lyophilized plasmas induced a small but significant bias in the slope of relationship between these thromboplastins of different species.

The Stability of the WHO Reference Thromboplastin NIBS & C 67/40

1979 ◽  
Vol 42 (04) ◽  
pp. 1135-1140 ◽  
Author(s):  
G I C Ingram
Keyword(s):  
Human Brain ◽  
Collaborative Study ◽  
Calibration Constant ◽  
Long Term Stability ◽  
Freeze Dried ◽  
Show Evidence ◽  
Human Material ◽  
Reference Preparation ◽  
The Stability

SummaryThe International Reference Preparation of human brain thromboplastin coded 67/40 has been thought to show evidence of instability. The evidence is discussed and is not thought to be strong; but it is suggested that it would be wise to replace 67/40 with a new preparation of human brain, both for this reason and because 67/40 is in a form (like Thrombotest) in which few workers seem to use human brain. A �plain� preparation would be more appropriate; and a freeze-dried sample of BCT is recommended as the successor preparation. The opportunity should be taken also to replace the corresponding ox and rabbit preparations. In the collaborative study which would be required it would then be desirable to test in parallel the three old and the three new preparations. The relative sensitivities of the old preparations could be compared with those found in earlier studies to obtain further evidence on the stability of 67/40; if stability were confirmed, the new preparations should be calibrated against it, but if not, the new human material should receive a calibration constant of 1.0 and the new ox and rabbit materials calibrated against that.The types of evidence available for monitoring the long-term stability of a thromboplastin are discussed.

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