Method definition

ICH Guideline (1994) Validation of analytical methods (Definition and Terminology). IFPMA, Geneva. 

ICH (1994) ICH Topic Q2A (ICH Harmonised Tripartite Guideline) Validation of analytical methods Definitions and terminology (CPMP/ICH/381/95), ICH, London... 

Java retains an explicit runtime representation of class, interface, and method definitions in its compiled class form the reflection API is a facility for accessing this information. For every class that is loaded into a running system, Java instantiates a single instance of the predefined class Class. There is a static method for dynamically loading any class based on its name and several methods for examining the structure of a class definition. 

The outcome of planning should include the generation of a method definition requirement document (MDRD) in which all stake holders agree, prior to method development, on the critical attributes of the method. Considerations such as what impurities/degradation products should be monitored, requisite reporting thresholds, the need for an MS-compatible method, if identical methods for DP and DS are required, etc., should be clearly decided and agreed upon by all stakeholders. 

Method development and optimization are started with review of the currently available methods within the company or in literature. Available methods are used as a starting point and evaluated against the method requirements set in the method definition. If necessary the method is optimized or redeveloped in order to fulfill the requirements. DOE tools (response surface design) are preferentially applied to obtain the best optimal conditions in terms of robustness. Application of DOE methodology is not new in chromatography and DOE is frequently applied also for enantiomeric separations in Especially in... 

Provide guidance on how to develop the most relevant hazard effects (PNEC) data i.e. the eco-toxicity testing strategy and methods definition per environmental compartment exposed. 

Although no free epinephrine is excreted under the conditions of those experiments just described, it is permissible to question whether they are representative of the fate of epinephrine as it is secreted in the body, or whether conjugation is a mode of inactivation of catechol pressor amines administered as drugs. The relatively minute amounts of adrenaline or noradrenaline secreted normally and the limitations of present analytical methods definitely handicap a direct approach to the problem. However, it has been possible to study the fate of adrenaline secreted by the body in a more or less physiological type of experiment. 

Q2A Validation of Analytical Methods Definitions and Terminology CPMP/ICH/381/95 Step 5... 

ICH, Q2A Validation of analytical methods Definitions and terminology, October 1994. 

C Under what conditions is the effecliveness-NTU method definitely preferred over the LMTD method in heat exchanger analysis ... 

ICH Q2A Validation of Analytical Methods (Definitions and Terminology), October 1994, Implementation (Step 5) EU Adopted by CPMP, November 94, issued as CPMP/ICH/381/95 MHW Adopted July 95, PAB/PCD Notification No. 755 FDA Published in the Federal Register 1995, 60, 11,260. 

Lindsay K, et al. Quantitative detection of hepatitis C vims RNA with a solid-phase signal amplification method Definition of optimal conditions for specimen collection and clinical application in interferon-treated patients. Hepatology 1994 19 1337-41. 

Implementation of the recommendations in the following section should take into account the ICH/VICH Guidelines Validation of analytical methods definitions and terminology" (CPMP/ICH/381/95 and CVMP/VICH/590/98) and "Validation of analytical procedures methodology" (CPMP/ICH/281/95 and CVMP/VICH/591/98). 

The explicit definition of method fragments using the NATURE situation-based process metamodel [366, 937]. A process engine can mechanically interpret method definitions and, based on their enactment, provide situated support. 

The integration of the method definitions with tool models into the so-called environment metamodel that lays the foundation for the process integration of tools. 

Thus, a loosely process-integrated tool is not able to provide by itself integrated method guidance based on method definitions. The guidance of the user inside the tool is restricted by the interaction patterns prescribed by its tool vendor. Nevertheless, the loose process integration of a tool can bring benefits in the following two cases ... 

Method definitions are integrated with tool models in environment models. These environment models are enriched with runtime semantics (e.g. Petri-Net extensions) and can get mechanically interpreted by the process engine, when method guidance is demanded. 

Whereas method definitions are biased by perceptions, process traces provide... 

In the context of IMPROVE, commercial and third-party tools had to be integrated into the engineering design environment. They were mostly equipped with a COM interface (e.g. Aspen Plus, Comos PT, or Documentum). Hence, our approach concentrated on COM (Component Object Model [846])" . COM follows the object-oriented paradigm, i.e. COM components represent subsystems, consisting of a set of classes including attribute and method definitions, relationships between classes, and a set of interfaces to access the subsystem. For every COM interface, fixed by standardization, a textual description is available in form of a so-called type library or a dynamic link library, respectively. 

From the software engineering perspective, work process models in CLiP are evaluated by method engineers in cooperation with chemical engineers, and they are translated into method definitions represented as NATURE contextual models. Thus, the interpretation is primarily based on the mapping of CLiP activities to the three types of NATURE contexts. 

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