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Considering Protocols Critically

Many practices end up acquiring the role of protocols that are passively followed as routines, without evaluating when they are reasonable and when they become unreasonable. The previously mentioned use of air conditioning whatever the outdoor temperature can be viewed as a telling example. Many others can be identified simply by looking around us . [Pg.12]

Indirect invitations to environmentally friendly behaviours may take place in a variety of situations. The responses may be largely different in different contexts. For instance, at a meeting, referring to some material sent electronically, a person may say Let us not print all this, so we save some trees . If the other persons have already been sensitized to the need to save resources, they will agree immediately, because they are aware of the motivations. If the other persons have not yet been sensitized to the need to save resources, they will perceive the invitation as unnecessary and awkward. On the other hand, making environmentally friendly invitations and statements is a way to slowly convey important messages. The efficacy increases if the number of persons making such invitations and statements in a certain context increases with time. [Pg.13]


Since surface preparation protocols are of critical importance in dictating the uhrathin deposition, in this section we wiU consider protocols for cleaning IREs and preparing metal substrates. [Pg.389]

Another question is whether an endpoint reflecting the status of CMI should be included in any DIT protocol.1719 For the measurement of CMI, roundtable participants suggested that a validated DTH or T-cell responses to anti-CD3 be evaluated.38 The DTH assay is considered by the NTP as part of the Tier II test panel.3 Although reports indicate that the delayed-type hypersensitivity (DTH) response can be assessed in weanling rats.41 roundtable participants agreed that data are lacking as to whether cell-mediated immune (CMI) assessments in younger animals are feasible.38 Ultimately, the characterization of a validated endpoint which measures CMI, and the determination of whether such an endpoint should be an essential part of a DIT framework remain critical research needs. [Pg.358]

Cleaning validation protocols should describe the equipment to be cleaned, procedures, materials, acceptance criteria, parameters to be monitored and controlled, and the analytical methods to be employed for testing. Validation of cleaning procedures should reflect equipment to be used for key and final intermediates and APIs. The selection of cleaning procedures to be employed should be based on material solubility and cleaning difficulty. The calculation of residue limits should consider the potency, toxicity, and stability of critical materials. [Pg.435]

PQ is intended to demonstrate that the process will function correctly in its normal operating environment. The demonstration may involve pilot lots, commercial-scale lots, or carefully designed simulations of either. In the case of drug substances, PQ protocols often involve individual modules (e.g., steps, unit operations) of a new process prior to pilot or commercial scale-up of the full process. When a given critical process parameter cannot be simulated at less than commercial scale, all other process parameters are often established first, to avoid potential interference with the first commercial batch that must involve the sensitive parameter. The three full-size lots required to authorize commercial distribution can, if desired, represent key PQ experiments however, there is no limit to the number of subsequent commercial lots that can also continue to be considered part of the PQ step in a validation life cycle. [Pg.838]

Whereas it is accepted that validation data on the first production scale batches may not be available at the time of submission, it is considered essential that valid manufacturing processes are used and the data submitted in the application verify the validity of the process. Where production scale data are not available at time of submission, validation can be conducted in two steps a thorough characterization of the critical process parameters at pilot scale (presented in the dossier), followed by a formal validation program on production scale for which a protocol is included in the dossier. [Pg.877]

Improvement schemes can be defined as a succession of individual interlaboratory studies in which several laboratories analyse the same test samples for the same characteristics (usually the content of an analyte), following a similar protocol to validate each individual step of their own analytical method (Quevauviller, 1999a). They enable laboratories to develop and validate all steps of new or existing analytical procedure(s) in adequately organised successive exercises which may be considered as preliminary studies for laboratory or method performance studies or certification of RMs (Griepink and Stoeppler, 1992 Quevauviller, 1998b). Such programmes are particularly valuable in the case of speciation studies since the analytical procedures include several complex and critical steps. [Pg.140]

One of the critical areas considered by the FDA in reviewing a clinical protocol is the merit of a clinical research investigation. The introduction should satisfy the reviewer that this study will attempt to produce a reliable solution to a scientific question about the drug being tested. [Pg.228]


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