4Pi Microscopy of the Nuclear Pore Complex
Fig. 1 4Pi setup. (a) Scheme of the commercially available 4Pi setup (TCS 4Pi microscope, type A, Leica Microsystems, Mannheim, Germany). O1 and O2: objective lenses; S: sample; BS: beamsplitter;…
Optogenetics: Optical Control of a Photoactivatable Rac in Living Cells
Fig. 1 Cartoon diagram of the photoactivatable Rac (PA-Rac). A LOV domain and its C-terminal Jα helix are fused to the N-terminus of a constitutively active mutant of Rac1 and…
Fluorescence Microscopy-Based RNA Interference Screening
Plate type Advantage Drawback Proposed application 96-Well plate Large number of cells per well, area ~30 mm2 Low number of wells Validation screen with preselected low number of targets 384-Well…
Process Control and Control Charts
Figure 10.2 Normal distribution. Source: PDA TR-59.5 Table 10.1 Significance of Cp Figure 10.3 Using a histogram of a CQA to produce a normal distribution curve. Source: www.moorestream.com.7 Cp=Process Capability….
Assessment
Figure 7.2 ICH Q9 approach. Source: ICH Q9.7 The risk referred to, in this case, is the risk to the patient. But this risk may come from many places. There…
the Protocol
Table 8.2 Process Model Tests in the PPQ are based on the production batch record. Normally the product will be made according to the batch record (at target), however, during…
Protocol Test Ranges
Figure 8.1 Understanding set point development. Figure 8.2 Graphical approach to set point relationships. Notice in Fig. 8.1 the Normal Operation Range falls within the Proven Acceptable Range that falls…
Considerations
Testing In general, software qualification, as discussed below, requires vigorous testing along with its associated hardware. This testing needs to include the actual operation of the field instruments (valves, etc.),…
Protocols—Installation Qualification (IQ) and Operational Qualification (OQ)
Table 5.2 OQ—Operating Parameters/Function Tests One function of these protocols is to document the original installation conditions; and a second important function is to demonstrate that the equipment is suitable…
