Analytical Methods. Catalent, in the development of analytical methods for a Generic Product, whether on its own behalf or on behalf of a third party, shall not use the services of any person, whether an employee or contractors, in the development of such methods, who either (i) provided analytical method development services on behalf of Catalent under this Agreement or the Development Agreement, or (ii) has such intimate knowledge of the Client’s analytical methods or the manner in which such methods were developed that such persons participation in the development of the analytical method for a Generic Product could reasonably be determined to materially accelerate the development of such methods for the Generic Product. “Generic Product” shall mean [***].
Analytical Methods. Analytical methods used for testing the API(s): compendial analytical methods must be verified and all others must be validated prior to use Development (early clinical phase) Supplier provides verification of analytical methods for intended use (see Note). Note: in case API lots will be used for clinical phase 3 studies, or prior to the validation campaign at the latest, the analytical methods should be validated according to ICH Q2 (R1) guidelines. Any significant changes to these analytical methods must be approved by the Client via a formal Change Control system.
Analytical Methods. Developing and validating analytical methods including but not limited to dissolution, assay, and stability as agreed upon by the Parties.
Analytical Methods. The following methods will be used by the Owner in analyzing filters used to collect air samples. The filters used shall be in accordance with the referenced methods.
Analytical Methods. During a term not to exceed twelve months after the Effective Date, to the extent that resTORbio requests in writing that Novartis transfer RAD001 analytical methods for drug substance release and RAD001 analysis/stability to resTORbio or its designee, such activities will be provided at no additional cost to resTORbio and for no more than a total of [***] hours of work, and will be delivered approximately three months following such request, and are subject to the execution by [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED resTORbio of a separate, commercially standard confidentiality agreement to be provided by Novartis. Any additional work related to the transfer of analytical methods upon resTORbio’s reasonable request will be charged by Novartis to resTORbio at the rate of $[***] per man hour (plus any applicable expenses).
Analytical Methods. NEKTAR AL is responsible for monitoring and complying with compendial (USP, Ph. Eur., JP) test methods and procedures as they apply to the SELECTED REAGENT. COMPANY may review any new non-compendial test methods transfer, qualification, and/or validation for the SELECTED REAGENT during the annual quality audit.
Analytical Methods. DPC shall be responsible for providing the API standards for the assay and impurities for analytical methods validation, subject to written approval in advance by NovaCardia. DPC shall perform: (i) development and validation of all API analytical methods set forth on Schedule A hereto, (ii) Materials USP/NF monograph testing, and (iii) all analytical and microbiological testing for API and for release of Pre-Commercial Lots. All Materials supplied by DPC shall comply with USP/NF requirements. DPC shall conduct the stability work for the experimental and clinical batches of API as established in the stability protocol set forth in Schedule B.
Analytical Methods. 6.1.1 SurModics shall implement and maintain in-process material and final Product analytical methods.
Analytical Methods. Unless otherwise specified by the Foundation Services Manager (any such request to be documented in the applicable Steering Committee meeting minutes), all Compounds shall be analyzed using LCMS. Evotec shall (i) conduct NMR sampling of 10 % of all library and procured Compounds and (ii) conduct NMR sampling of 100% of single synthesized Compounds.
Analytical Methods. Target treatment effects As described earlier, the primary analysis of a randomised trial often uses the ITT approach. The ITT approach is typically used as a method of estimating effectiveness, which is considered to be the effect of treatment offer on outcome (Xxxxxx and Xxxxxxxxx- Xxxx, 2012). This target treatment effect is sometimes known as the de facto effect (Mallinckrodt et al., 2017). It is of particular interest to those designing and planning the delivery of health services because it describes the impact of a treatment in real-world conditions. The ITT approach is described as “conservative” because estimates are biased towards the null (only in the context of a superiority trial; Xxxxxx and Xxxxxxxxx-Xxxx, 2012). The approach is linked to the design of a pragmatic trial. RCTs that are described as such take place in a ‘naturalistic’ or ‘real-world’ clinical setting and have few exclusion restrictions – this is in order to maximise external validity, thereby making the findings generalisable to a wide population (Xxxxxxx and Xxxxx, 1999; Sedgwick, 2014). Another target treatment effect is efficacy, the effect of treatment receipt on outcome (Xxxxxx and Xxxxxxxxx-Xxxx, 2012). This is sometimes known as the de jure effect (Mallinckrodt et al., 2017). Patients and clinicians wishing to make informed decisions about the management of medical conditions would often prefer to know the efficacy and safety of an intervention when taken under optimal conditions (as this will demonstrate the greatest possible effect; Xxxxxxx and Xxxxx, 1999). Trials can be designed to answer this question and these are known as “explanatory” RCTs (Sedgwick, 2014). Such trials occur in carefully controlled circumstances and use exclusion restrictions to create a narrowed population to answer the question, for example excluding those with other
