Method validation Sample Clauses

Method validation. Linearity and limit of detection Linearity was evaluated by preparing calibration lines (n = 3) on three consecutive days. The calibration ranges are shown in Table 3. All calibration lines were fitted to a 1/x2 weighted linear regression model. The limits of detection (LOD) and limits of quantification (LOQ) were calculated as LOD = 3 × Sa/b, LOQ = 10 × Sa/b, where Sa is the standard deviation of the y-intercept, b is the slope of the calibration curve25.
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Method validation. A procedure blank was analyzed periodically and it was prepared using the same reagent and procedures for the samples. In addition, to assess efficiency of recovery procedure, two of the 14 samples were spiked with 20(mg/L) PAHs standard. Since the LoD calculation performed in the lab was insufficient, the LoD was determined based on an interpolated method using the calibration curves provided by the laboratory. Percent recovery calculations = {(Spike result/expected result) * (spike volume/original volume)} *100
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Method validation. Feasibility studies have proven a [+] method acceptable for the determination of drug levels in [+] matrices. Each component of the study drug is assayed independently. The method will be validated (GLP) in matrices corresponding to samples specified by the clinical study protocol for pharmacokinetic analysis [+].
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Method validation. All methods used to test / inspect the components involved in manufacturing / packaging of the Product or testing / inspection of the Product shall be validated according to cGMP requirements and ____________ procedures.
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Method validation. All methods used to test / inspect the material shall be validated according to cGMP requirements and KING’s procedures.
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Method validation. Heading 4.1.7
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Method validation. The validation of the method was discussed in detail in our previous study (Xxxx et al., 2020). In that study, the model presented here was applied to a relatively large data set of human eCAP growth function recordings. This data set consisted of 4982 eCAPs from 111 CI recipients who received a HiRes90K device (Advanced Bionics, Valencia, CA), either with a 1J or a Mid-Scala electrode array. The eCAPs were recorded measured on eight odd electrode contacts with stimulus levels from 50 to 500 current unit. We have validated both steps of the method. First, we validated step one, namely the estimation of the URh, by comparing the resulting eCAPps obtained with our estimated URh (Dong et al., 2020) to the eCAPps obtained with URgp (Xxxxxxx et al., 1992) in step two. Based on the goodness of fit measure (NRMSE, the normalized root mean square error provided in MATLAB), the eCAPs achieved with URh were better than those achieved with URgp (Xxxx et al., 2020). The URh reduced the fitting error for all eCAPs by approximately 18%. This result supported our assumption that the UR of human AN fibers differs from the URgp (Xxxxxxx et al., 1992). The assumption that the UR is constant may be contested, as it can hypothetically vary across subjects, electrodes and/or current levels. However, the assumption of UR constancy is necessary, because a fixed UR is needed to optimize the derivation of CDLD in step two. As such, the UR is used solely as a necessary intermediate step to extract a valid CDLD from the eCAP. While a fixed UR is necessary and sufficient for our goal, our deconvolution model can nonetheless be used to investigate whether the UR differs across subjects or different stimulus conditions by running the deconvolution model for each condition separately. However, to more conclusively resolve such questions, direct recordings of the URh are necessary. Second, we validated the extraction of the CDLD with the fixed UR by evaluating the goodness of fit of the predicted eCAPs. In general, 93.6% of the recorded eCAPs were predicted accurately, with a >0.9 goodness of fit (NRMSE). Thus, these CDLDs provided a good picture of the temporal firing properties of the AN fibers in eCAPs. Importantly, realistic CDLDs were obtained that lacked any negative phases without any post-processing. The remaining 322 eCAPs had deviant waveforms, with relatively small N1 peaks and large P1 peaks; thus, they could not be predicted well with our model (NRMSE <0.9). This may have be...
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Related to Method validation

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Method of Liquidation Upon the happening of any of the events specified in Section 10.1 above, which require the Partnership to be liquidated and dissolved, the then General Partner of the Partnership or, in the event there is no remaining General Partner of the Partnership, such persons as may be designated by a majority of the Limited Partners, shall convert the Partnership assets into cash, and shall account for all cash proceeds separately for each Restaurant. All such cash shall be applied and distributed separately for each Restaurant in the following manner and in the following order of priority:

  • Method of Notice All notices shall be given (i) by delivery in person (ii) by a nationally recognized next day courier service, (iii) by first class, registered or certified mail, postage prepaid, (iv) by facsimile, or (v) by electronic mail] to the address of the OETC Contract Administrator or Contractor's Contract Coordinator or such other address as either party may specify in writing.

  • Method of Giving Consent Any consent of a member required by this Agreement may be given by a written consent.

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

  • Traceability 11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code.

  • Method of Computation To determine the Adviser’s liability with respect to the Excess Amount, each month the Fund Operating Expenses for the Fund shall be annualized as of the last day of the month. If the annualized Fund Operating Expenses for any month exceeds the Operating Expense Limit of the Fund, the Adviser shall first waive or reduce its investment advisory fee for such month by an amount sufficient to reduce the annualized Fund Operating Expenses to an amount no higher than the Operating Expense Limit. If the amount of the waived or reduced investment advisory fee for any such month is insufficient to pay the Excess Amount, the Adviser shall also remit to the Fund an amount that, together with the waived or reduced investment advisory fee, is sufficient to pay such Excess Amount.

  • Auction Schedule; Method of Submission of Orders (a) The Fund and the Auction Agent shall conduct Auctions for Preferred Shares in accordance with the schedule set forth below. Such schedule may be changed at any time by the Auction Agent with the consent of the Fund, which consent shall not be withheld unreasonably. The Auction Agent shall give notice of any such change to BD. Such notice shall be received prior to the first Auction Date on which any such change shall be effective. Time Event ---- -----

  • Time and Method of Payment (Amounts Distributed by the Administrative Agent). Except as otherwise provided in Section 4.02, all amounts payable to any Funding Agent or Investor hereunder or with respect to the Series 2019-1 Class A-1 Advance Notes shall be made to the Administrative Agent for the benefit of the applicable Person, by wire transfer of immediately available funds in Dollars not later than 3:00 p.m. (Eastern time) on the date due. The Administrative Agent will promptly, and in any event by 5:00 p.m. (Eastern time) on the same Business Day as its receipt or deemed receipt of the same, distribute to the applicable Funding Agent for the benefit of the applicable Person, or upon the order of the applicable Funding Agent for the benefit of the applicable Person, its pro rata share (or other applicable share as provided herein) of such payment by wire transfer in like funds as received. Except as otherwise provided in Section 2.07 and Section 4.02, all amounts payable to the Swingline Lender or the L/C Provider hereunder or with respect to the Swingline Loans and L/C Obligations shall be made to or upon the order of the Swingline Lender or the L/C Provider, respectively, by wire transfer of immediately available funds in Dollars not later than 3:00 p.m. (Eastern time) on the date due. Any funds received after that time on such date will be deemed to have been received on the next Business Day. The Master Issuer’s obligations hereunder in respect of any amounts payable to any Investor shall be discharged to the extent funds are disbursed by the Master Issuer to the Administrative Agent as provided herein or by the Trustee or Paying Agent in accordance with Section 4.02, whether or not such funds are properly applied by the Administrative Agent or by the Trustee or Paying Agent. The Administrative Agent’s obligations hereunder in respect of any amounts payable to any Investor shall be discharged to the extent funds are disbursed by the Administrative Agent to the applicable Funding Agent as provided herein whether or not such funds are properly applied by such Funding Agent.

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