Analytical methodology Sample Clauses

Analytical methodology. The proposed IND analytical test methodologies for the RUT100-05 drug product are listed in Table 6.7.1. Table 6.7.1 Proposed IND Tests and Methodology [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]* [ ]*

Analytical methodology. Concentrations of LOXO-305 in plasma will be determined using a validated bioanalytical method. Specifics of the bioanalytical methods will be provided in a separate document. The concentrations of total and unbound LOXO-305 will be determined in a sample of predose plasma fortified with a known concentration of LOXO-305. The unbound fraction will be calculated based on total and unbound LOXO-305 levels. Samples of plasma may be analyzed for exploratory analyses of metabolites. If such analyses are conducted, the results will be reported separately by the Sponsor.

Analytical methodology. Plasma cysteamine concentration will be determined using methods employing Hydrophilic Interaction Liquid Chromatography (HILC) high pressure liquid chromatography (HPLC) tandem mass spectrometry (HPLC-MS/MS) (▇▇▇▇▇▇ and ▇▇▇▇▇▇ 2005; ▇▇▇▇▇, ▇▇▇▇▇▇ et al. 2006). White blood cell (WBC) cystine concentration will be determined using high performance liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) (▇▇▇▇▇▇ and ▇▇▇▇▇▇ 2005; ▇▇▇▇▇, ▇▇▇▇▇▇ et al. 2006).

Analytical methodology. These data were analyzed in a cross sectional design. The original data contained 2596 observations and the subset used for this analysis, mothers with children aged 5-5.5 years resulted in a sample size of 1248 observations. Data cleaning consisted of re-coding missing data from a default value of 9 to missing. Additionally, dummy variables were created for nominal categorical variables. For purposes of simplifying analysis, other dichotomous variables were re-coded so that a negative or “no” answer corresponded with a 0 and an affirmative or “yes” response was coded as 1. The outcome variable, school readiness, was measured by questions testing numeracy, literacy and adaptive behavior. Composite scores for the different components of school readiness were then created. This was done through a summation method, adding the scores of the questions that fell into a specific category of school readiness. Ultimately, composite scores were created for both numerical and literacy scores through the 10-part activity and composite scores for socialization, self-help, emotional control and communication were created from the adaptive behavior test. Numerical and literacy scores were summed to create a total score from the 10 activities. This score ranged from 0 to 36. Socialization, self-help, emotional control and communication scores were added to create an overall adaptive behaviors score. This score ranged from 0 to 40. The adaptive behavior score and the activities score were added to create an overall total school readiness score. This score ranged from 8-70. To address the research question of whether caregiver’s access to community health services is positively associated with the school readiness scores of their children, nine variables were selected that exemplify various aspects of health services through Anganwadi centers. These variables were examined for individual associations with the school readiness outcome and were also combined into a single score to test for a combined association with school readiness. The nine variables that were finally selected were the following: 1) Whether the caregiver registered the pregnancy at the Anganwadi center (AWC) 2) Whether the caregiver received TT vaccinations from the AWC 3) Whether the caregiver received any antenatal checkups from AWW 4) Number of IFA tablets the caregiver received from AWC 5) Whether the caregiver received supplemental nutrition from the AWC 6) Whether a Village Health and Nutrition Day (...