completing the method validation and transfer

... and culture The method validation section of this book discusses and provides guidance for the validation of common and not-so-common analytical methods that are used to support development and ... of the stability of the API and drug product Therefore, open dish (i.e., nonprotected) stability studies are carried out to understand the chemical and physical stability of both the API and the ... POTENCY METHOD VALIDATION Method development Method validation/ revalidation QC laboratory Figure 2.1 Life cycle of an analytical method of the drug substance and drug product, this validated method...

Ngày tải lên: 03/06/2014, 01:15

... internal standard and b) without internal standard Figure the corresponded product the deuterated standards with Standard chromatogram of ion scans Standard chromatogram of the deuterated standards ... position B the analytes can be eluted in backflush mode from the RAM phase with the gradient solvent and transferred to the analytical column for the separation of the analytes (see Figure 1) The starting ... charging and flushing the sample with the isocratic solvent to eliminate macromolecules and polar compounds into the waste, the transfer step to the analytical column can be initiated Turning the...

Ngày tải lên: 20/06/2014, 00:20

... changing the organic–aqueous ratio, the pH of the aqueous phase, the flow rate of the mobile phase and the temperature of the column on the retention time and on the shape of the AMFZ and paracetamol ... pH of the aqueous phase, the flow rate of the mobile phase and the temperature of the column on the retention time and on the shapes of the analyte peaks The results of the robustness studies (Table ... that the pH of the aqueous phase significantly changed the symmetry of the peak, which is in accordance with the results obtained from the simulations with the Pallas software The lower the pH, the...

Ngày tải lên: 10/12/2016, 13:40

... opportunities and their merits and limitation Moreover, the nature of gearing and potential effected of high gearing on perceived risk and cost of capital I-Analysis of the reasons behind takeovers and the ... than another while the lower NPV project has a higher IRR Based on the information analysis above, we know how to calculate the four -method Hence, the most suitable method is NPV, then the second ... years in the life of the investment The ARR does not guarantee that the cash inflows are the same in a given year It simply guarantees that the return averages out to the average of return’ (thefreedictionary.com)...

Ngày tải lên: 17/02/2014, 13:02

... green and the nitrogen atoms of R120 and K22 in blue The open form of MurA is unliganded (A) and the closed conformation (B) contains fosfomycin (orange) and UDPNAG (purple) in the active site The ... constructed the K22V/R120V and K22V/R120K double mutants (see Materials and methods) and repeated the analysis of adduct formation in the absence and presence of UDPNAG As shown in Fig 3, the K22V/R120K ... change upon ligand binding The loop region of the upper domain moves towards the active site of the enzyme, thus shielding the substrates (and ligands) from bulk solvent A detailed thermodynamic...

Ngày tải lên: 19/02/2014, 13:20

... with the difference in the circulating concentrations of Gamide and transferrin In the present study, we explored further the interaction between Gamide and transferrin, and characterized the ... a ligand for the first ferric ion, and that Glu8 and Glu9 act as ligands for the second ferric ion, in the gastrin– ferric ion complex for both Ggly [12] and Gamide [13] To characterize the involvement ... [3] and iron-free [apo-transferrin (ApoTf)] forms [4] The chain is folded into two lobes, the N-lobe and C-lobe, derived from the N-terminal and C-terminal halves of the protein, respectively The...

Ngày tải lên: 07/03/2014, 02:20

... a, b and c are component absorbance values contributed by the relevant flavin in the oxidized, semiquinone and reduced states, respectively E is the observed potential, and E1¢ and E2¢ are the ... to CPR and NOS, the rate of hydride transfer in NR1 (% s)1) is substantially less than the rates in CPR (% 200 s)1 [24]); and NOS (% 200 s)1 for the first hydride transfer reaction in the FAD-FMN ... mV) and that for NADPH ()320 mV) The smaller separation between the ox/sq and sq/hq midpoint potentials of the NR1 FAD domain (50 mV cf 85 mV for CPR FAD and 159 mV for NR1 FMN) explains the rather...

Ngày tải lên: 23/03/2014, 21:20

... identification algorithm The numerical simulations are taken when the sensor is placed at the distances L/4, L/2 and L from the base In Fig 3, the shapes of the 1st mode, the 3rd mode and the 5th mode are ... term The magnitude of the error term depends on the number and the locations of the sensors The numerical simulation is applied to a base excited cantilever beam to illustrate the algorithm The ... algorithm is the requirement of the knowledge of entire state vector x(t) Combination of the identification algorithm and the modal superposition method The incomplete measurement leads to the incomplete...

Ngày tải lên: 28/03/2014, 13:20

... identification algorithm The numerical simulations are taken when the sensor is placed at the distances L/4, L/2 and L from the base In Fig 3, the shapes of the 1st mode, the 3rd mode and the 5th mode are ... term The magnitude of the error term depends on the number and the locations of the sensors The numerical simulation is applied to a base excited cantilever beam to illustrate the algorithm The ... algorithm is the requirement of the knowledge of entire state vector x(t) Combination of the identification algorithm and the modal superposition method The incomplete measurement leads to the incomplete...

Ngày tải lên: 28/03/2014, 13:20

... to change the codons of the Cys residues to Ala The presence of the mutations were verified by digestion with the enzymes cleaving the introduced restriction sites and the sequence of the gene ... 10, 20, 30 and 60 and the transfer was stopped by addition of 20 nmol K3Fe(CN)6 and 50 nmol EDTA which led to an immediate destruction of the FeS cluster at IscA The samples were then frozen ... of the cluster and the variant C34/44/75A was still able to bind a FeS cluster we concluded that the [2Fe2S] cluster is bound by C110 and C112 in between the two protomers of the IscA dimer The...

Ngày tải lên: 31/03/2014, 01:20

Ngày tải lên: 24/04/2014, 17:24

... of the IPSS QoL score and for the low medium and high impact categories on the BII The F statistics for the PPSM Total Score, PPSMGlobal and PPSM-Pain comparisons with the IPSS, IPSS QoL Item and ... in the LB participated in the study design, the analysis and interpretation of data and revision of the manuscript AG participated in the study design, analysis and interpretation of data and ... of change and their satisfaction with that change Using data from a randomized clinical trial in the USA, the results support the reliability, validity and responsiveness to change of the PPSM...

Ngày tải lên: 18/06/2014, 18:20

... with the logo of the university as a gift in exchange for their time In addition to completing the PSSCAN, they also indicated their age and gender, and responded to the question of whether or ... relationship between PSSCAN data and the criterion indices (HADS anxiety and depression subscales), and allowed the computation of the overall fit statistic, and sensitivity and specificity A perfect ... 2b shows the ROC curves of the PSSCAN depression subscale with the clinical cutoff of the HADS as the criterion This resulted in an AUC of 91 (P < 001) The corresponding ideal cutoff on the PSSCAN...

Ngày tải lên: 18/06/2014, 19:20

... correlate with the mental component summary of the SF-36 and with the impact of the child's health on parent's time and emotions and on the family, as measured by the CHQ-PF50 Because both the psychosocial ... was required to be the primary caregiver of the child, and had to be willing to participate throughout the course of the study and to complete the questionnaires at Weeks and The questionnaires ... design and coordination of the study and helped to draft the manuscript RD participated in the design and coordination of the study XL contributed statistical analysis and helped to draft the manuscript...

Ngày tải lên: 18/06/2014, 22:20

... with the generic SF-36 and the VAS for pain Hypotheses were formulated about the expected magnitude and direction of relationships between the subscales of the KOOS questionnaire and the other ... version and r = 0.24 and 0.64 for the Chinese version of the KOOS [24] Kessler et al compared the subscales of the KOOS with the SF-12 for the same population and found a low correlation between the ... instruments The formulation of the hypotheses was based on the starting point that there is a clear distinction between the subscales of the KOOS questionnaire We defined the construct validity of the...

Ngày tải lên: 18/06/2014, 22:20

... France and 93.6% in Spain for the QUALIOST®, and between 68.9% in France and 83.5% in Spain for the SF-36 Validation of the hypothesised structure of the QUALIOST® (see Table 1) Analysis of the ... patients and were therefore included in the analyses of the hypothesised structure and internal consistency reliability Longitudinal data were available for 80.9% of the patients for the responsiveness ... (M0) and then every six months using the SF-36 and QUALIOST® The 12 countries of the SOTI trial were Australia, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Spain, Switzerland...

Ngày tải lên: 20/06/2014, 15:20

... correlate with the mental component summary of the SF-36 and with the impact of the child's health on parent's time and emotions and on the family, as measured by the CHQ-PF50 Because both the psychosocial ... was required to be the primary caregiver of the child, and had to be willing to participate throughout the course of the study and to complete the questionnaires at Weeks and The questionnaires ... design and coordination of the study and helped to draft the manuscript RD participated in the design and coordination of the study XL contributed statistical analysis and helped to draft the manuscript...

Ngày tải lên: 20/06/2014, 16:20

... season FFSs Farmers monitor the presence of pest and diseases and they are now confident in their ability to identify them They also understand the importance of recognising the right stage of citrus ... and they will continue to keep records It helps them to select pesticide since they now know which pesticide they used and they can assess results They are now aware of their input costs so they ... beneficial and they will continue to keep records but in simpler form in their own notebook It helps them to select pesticide since they now know which pesticide they used and they can assess results They...

Ngày tải lên: 21/06/2014, 05:20

... for m ≥ N + Furthermore, for each m ≥ N + the right-hand side of Eq (21) leads to the three-term recursion relation (8a) and (8c) for the coefficients cn and sn Therefore the right-hand side of ... demonstrate the resulting improvements On the other hand, a method for the accurate evaluation of the S-matrix for multi-channel analytic and non-analytic potentials in complex L bases is presented in the ... Hilbert space, and because (H0 − E) is tridiagonal in the basis {φn }, ˜ and therefore does not connect the N terms in the expansion of ⌽ or the first N ˜ ˜ terms in the expansion of S and C with...

Ngày tải lên: 27/06/2014, 05:20

... soil from the planting site The plants were watered daily with the same nutrient solution as used in aeroponic culture The roots were cut just before the transfer to the Polybags and the stalks ... with air and sealed The bags were stored in darkness for and days (4DD, 6DD) or in the shade for and days (4DS, 6DS) The two other treatments consisted of direct planting of seedlings from the aeroponic ... land, having a moderately deep clay layer and poor drainage Plant growth rates were calculated from the height measured between the collar and the last living bud before transplanting and at and...

Ngày tải lên: 08/08/2014, 00:22