Ideal protocol

The general challenges of protein analysis (and thus applicable to LOC-based analysis) include those related to the composition of the proteome and the analytical methods. No ideal protocols exist, for example, to selectively, repro-ducibly, and non-intrusively isolate the full complement of proteins from tissue samples. The vast diversity in protein expressions, charged states, molecular sizes, and configurations makes sample preparation a challenging task. Also, extreme... 

Through prioritisation, the sequence of the qualification and validation activities is formulated. For each device or process acceptance criteria have to be set based on a risk assessment including critical aspects for the total product range. Tests in relation to acceptance criteria are described in test plans. Tests have to be reported and the approved report might be the base for future change control. Ideally, protocols and reports with a fixed layout are used. 

Enzyme catalysis is specific, controlled, gives few by-products and is generally conducted in water under mild conditions of temperature and pressure. An ideal protocol for the polymer industry. Now, we have pioneers in the laboratory utilizing enzymes to produce addition polymers from vinyl monomers, condensation polymers from alcohols, amines and acids. One addition polymer is in commercial production in the UK utilizing specific enzyme condensation polymerization of primary alcohol groups in the... 

I have just sketched the ideal protocol. In practice, single photons are very... 

There is an obvious order to these four facets of analytical methodology. Ideally, a protocol uses a previously validated procedure. Before developing and validating a procedure, a method of analysis must be selected. This requires, in turn, an initial screening of available techniques to determine those that have the potential for monitoring the analyte. We begin by considering a useful way to classify analytical techniques. 

Due to the abundance of epoxides, they are ideal precursors for the preparation of P-amino alcohols. In one case, ring-opening of 2-methyl-oxirane (18) with methylamine resulted in l-methylamino-propan-2-ol (19), which was transformed to 1,2-dimethyl-aziridine (20) in 30-35% yield using the Wenker protocol. Interestingly, l-amino-3-buten-2-ol sulfate ester (23) was prepared from l-amino-3-buten-2-ol (22, a product of ammonia ring-opening of vinyl epoxide 21) and chlorosulfonic acid. Treatment of sulfate ester 23 with NaOH then led to aziridine 24. ... 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

In the SMMT process, draft protocols are reviewed, and guidance provided to the sponsor to help ensure that the format and specifications are adequate. The protocol should be approved by CVM prior to the initiation of the method trial. Once the protocol and method description are acceptable to CVM, the methods are sent to the participating laboratories for review, and a method demonstration is scheduled. The method demonstration, attended by all participating laboratory analysts, involves review of the study protocol and method SOP and a laboratory demonstration of the method. Ideally, all revisions are completed by the end of the demonstration and the study protocol is signed. 

The Study Director/Principal Investigator should ideally discuss all multi-site studies with QA personnel prior to study initiation (or prior to the issue of the protocol amendment if work is not detailed in the protocol). When acting as Study Director, a copy of the current GLP certificates should be requested from sub-contracted facilities and should be retained in QA. 

Ideally, to establish a causal relationship between caffeine and improved athletic performance, evidence would be obtained from epidemiological population studies, followed by careful, double-blind, placebo controlled experimental protocols isolating the purported etiological agent (caffeine), and eventually culminating with strong laboratory findings... 

Provide either in vitro or in vivo assay results for representative compounds, describe how the in vitro or in vivo assay protocol is performed, and describe how and why the test results demonstrate that the tested compounds exhibit a useful pharmaceutical property. Ideally, provide and link in vitro assay results to in vivo assay results that in turn demonstrate that the claimed compounds can be used to treat or prevent a disease. Describe how to administer the application s compounds and intended administration recipients (e.g., humans), including dosage amounts and dosage forms (e.g., pills, tablets, capsules), possible ways of administering the dosage... 

The IHC stain procedure is a multistep staining protocol, the various steps intended to provide amplification of stain results. Therefore, a control system must include elements to control each step of the stain process. Such a control should also include a range of reactivities, and that range ideally would encompass the total expression range expected for the measured component. The control should also monitor each step of the multistep protocol. This author has devoted a number of years to this concept, resulting in a patented control for multistep staining processes.14 Such a control provides sufficient information to monitor every IHC stain run, and when the control is evaluated quantitatively, normalization of data from one stain run to another within the same laboratory, and even between laboratories. A process control is a measure of the stain protocol and does not take the place of a control for the primary antibody. While the primary antibody control should include range of expression level detection, a different primary control must be present for every primary antibody used in a stain run (Fig. 10.4). 

A systematic Materials Science approach is now highly appropriate for the pharmaceutical field. It may be envisioned that a protocol for the complete physical characterization of a solid material could be easily developed following the approach just outlined. Ideally, each lot of active drag, excipients, or formulated blends of these would be characterized as fully as possible at the early stages of drag development. A feedback loop would then be established after each formulation ran, in which the physical characteristics of the input... 

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