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package insert → see patient information leaflet; → see also Development Safety Update Report, Summary of Product Characterisitcs. packaging EC (IV): “all operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product”; → see also quarantine. packaging material EC (IV): “any material employed in the packaging of a medicinal product, excluding any outer packaging used for transportation or shipment; packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product”. packaging system syyn. Container closure system, (US): “sum of packaging components that together contain and protect the drug substance”. pairing → see matched pairs, randomisation. paper trail Integrity of the documentation record which allows a monitor or inspector to follow the process of events and confirm that the correct procedures were followed. parallel design → see design. parallel import Patented substances are supplied by the holder of the patent to low priced countries for their domestic needs, manufactured locally, and then reimported to the high price country of the originator, thus lowering it’s revenues; → see also marketing exclusivity, patent protection. parallel track policy As part of an expedited drug development program trials without concurrent control group may be conducted in parallel with controlled clinical trials for collection of additional safety and toxicity data; → see also non-comparative trial. parallel trade → see parallel import. parametric test Statistical test assuming a defined distribution of the data, e.g. a normal distribution. parent-child/foetus report ICH: “Report in which the administration of medicines to a parent results in a suspected reaction/event in a child/foetus”. parenteral administration Opposite: enteral a.; → see administration. Pareto’s principle is also known as the “80:20 rule”; end of the 19th century, the Italian economist Vilfredo Pareto observed that 80% of the land was owned by 20% of the population; 20% of the peapods in his garden produced 80% of the peas, etc. and led to far-reaching theories; this principle has been applied to management as well, e.g., 80% of the time of meetings is devoted to 20% of the business, 80% of the profit comes from 20% of the sales; → see also muench’s