Advice Pool - Reference and Education

As the residents of Herculaneum and Pompeii pursued their daily activities, a few wisps of smoke trickled from Vesuvius’ crater at approximately 10:00 AM.[27] It went unseen.

Next, at about 12:00 noon a steady, unbroken plume of smoke suddenly rose 9 miles into the air from Mt. Vesuvius as tremors rattled Pompeii, Herculaneum, Oplontis, Terzigno, and their surroundings. “In Campania, remarkable and frightful occurrences took place; for a great fire suddenly flared up at the very end of the summer. It happened on the wise Mt. Vesuvius,” Dio Cassius wrote in describing the eruption.[28]

Initially upo

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

n seeing the towering noontime volcanic column, people were awed and astonished. Then, within minutes as a thick rain of hot lapilli (Latin term for “small stones”),[29] pumice and ash began to fall on Pompeii, Oplontis, and Terzigno, carried by strong northwest winds pushing it to the southeast, the towns’ people hurriedly sought immediate shelter.

Soon the hot lapilli and ash were falling at a rate of about 4.75-6 inches per hour as deafening noises emanated from the volcano and a continuous stream of strong earthquakes shook the area. Upon hearing the loud explosions, many who had not left in the morni

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ng, fled back into their houses as others continued their retreat towards Pompeii and the coast of Oplontis, and as “pumice clasts comprised of tephra” with diameters of up to 3 inches rained down at speeds of up to 62 miles per hour, roofs and structures suffered damage while people in the streets suffered injuries, a few fatal.[30]

By 1:00 PM, “the carapace of rock sealing [Vesuvius] was blown out”[31] shooting some 10 miles into the air,[32] sending up a thick, dark cloud of dust and ash that blocked the sun, casting Pompeii and its surrounding areas into total darkness. “…suddenly a porten

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tous crash was heard, as if the mountains were tumbling in ruins; and first huge stones were hurled aloft, rising as high as the very summits, then came a great quantity of fire and endless smoke, so that the whole atmosphere was obscured and the sun was entirely hidden, as if eclipsed. Thus day was turned into night and light into darkness,” Dio Cassius wrote.[33]

When darkness enveloped the area as hot lapilli and ash rained down, many in Herculaneum realized it was time to flee. People “stopped to gather what belongings they could: money, jewelry, the family dog. Everybody rushed into the streets. So

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

me thought the sea was their route to safety; those who didn’t try to escape on boats assembled on the beach”[34] while others fled on foot towards Naples, “which ultimately proved to be the only path to safety.”[35]

There was widespread panic and chaos as people ran for safety. As they fled, in the words of Dio Cassius, “some [ran] from the houses into the streets, others from outside into the houses, now from the sea to the land and now from the land to the sea; for in their excitement they regarded any place where they were not as safer than where they were. [Furthermore] While this was going on,

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

an inconceivable quantity of ashes was blown out, which covered both sea and land and filled all the air. It wrought much injury of various kinds, as chance befell, to men and farms and cattle, and in particular it destroyed all fish and birds.”[36]

It was about this time that Pliny the Elder, serving in Misenum as admiral of the fleet was notified of the eruption as recounted by his son: “…between 2 and 3 in the afternoon my mother drew his attention to a cloud of unusual size and appearance. He had had a sunbath, then a cold bath, and was reclining after dinner with his books. He called for his shoes and

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

climbed up to where he could get the best view of the phenomenon. The cloud was rising from a mountain-at such a distance we couldn't tell which, but afterwards learned that it was Vesuvius. I can best describe its shape by likening it to a pine tree. It rose into the sky on a very long ‘trunk’ from which spread some ‘branches.’ I imagine it had been raised by a sudden blast, which then weakened, leaving the cloud unsupported so that its own weight caused it to spread sideways. Some of the cloud was white, in other parts there were dark patches of dirt and ash. The sight of it made the scientist in my uncle determi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ned to see it from closer at hand.

He ordered a boat made ready. He offered me the opportunity of going along, but I preferred to study – he himself happened to have set me a writing exercise. As he was leaving the house he was brought a letter from Tascius' wife Rectina, who was terrified by the looming danger. Her villa lay at the foot of Vesuvius, and there was no way out except by boat. She begged him to get her away. He changed his plans. The expedition that started out as a quest for knowledge now called for courage. He launched the quadriremes and embarked himself, a source of aid for more people than just R

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ectina, for that delightful shore was a populous one. He hurried to a place from which others were fleeing, and held his course directly into danger. Was he afraid? It seems not, as he kept up a continuous observation of the various movements and shapes of that evil cloud, dictating what he saw.

Ash was falling onto the ships now, darker and denser the closer they went. Now it was bits of pumice, and rocks that were blackened and burned and shattered by the fire. Now the sea is shoal; debris from the mountain blocks the shore. He paused for a moment wondering whether to turn back as the helmsman urged him. ‘Fortune

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

helps the brave,’ he said, ‘Head for Pomponianus (his friend).’"[37] With his decision, Pliny the Elder ordered the helmsmen to turn away from Pompeii, which was inaccessible and head for Stabiae.[38]

By 3:00 PM some of the residents of Pompeii were also fleeing as they realized the earthquakes and eruption weren’t ceasing. People “ran in different directions; some Pompeiians [sought] refuge in Moregine. Others head[ed] in the direction of… Nuceria. And still others [fled] to the seaport…”[39] Soon it became apparent that “an escape by sea [was] futile.”[40]

However, by 6:00 PM, t

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

he volcanic eruption appeared to be easing. As the eruption’s intensity eased, exhausted Pompeiian survivors emerged from buildings in search of an escape route. Individually and in small groups, “they trudged towards the southern sector of the urban area in the hope of reaching the roads at the edge of the city.”[41] By this time, Pliny the Elder had arrived at Stabiae to meet up with his friend. By this time, Pliny the Younger was completing his studies from the safety of Misenum. “…I finished up my studies, as I had planned. Then I had a bath, then dinner and a short and unsatisfactory night.”[42]<

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

/b> At the same time, some, mistakenly believing that the worst was over, began returning to survey the damage and salvage their belongings.

By 7:30 PM, Pompeii experienced the first roof collapses. In addition, a few fires, caused by “fallen lanterns,” burned, illuminating the town in the “unnatural darkness.”[43]

Then after about two hours of respite, shortly after 8:00 PM, the intensity of the volcanic eruption picked up. Falling lapilli and ash again rained down. As it fell on Pompeii and Stabiae, Pliny the Elder was awaiting favorable winds to depart” as recounted by his son: “At Stabiae, on the ot

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

her side of the bay formed by the gradually curving shore, Pomponianus had loaded up his ships even before the danger arrived, though it was visible and indeed extremely close, once it intensified. He planned to put out as soon as the contrary wind let up. That very wind carried my uncle right in, and he embraced the frightened man and gave him comfort and courage. In order to lessen the other's fear by showing his own unconcern he asked to be taken to the baths. He bathed and dined, carefree or at least appearing so (which is equally impressive). Meanwhile, broad sheets of flame were lighting up many parts of Vesuv

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ius; their light and brightness were the more vivid for the darkness of the night. To alleviate people's fears my uncle claimed that the flames came from the deserted homes of farmers who had left in a panic with the hearth fires still alight. Then he rested, and gave every indication of actually sleeping; people who passed by his door heard his snores, which were rather resonant since he was a heavy man. The ground outside his room rose so high with the mixture of ash and stones that if he had spent any more time there escape would have been impossible. He got up and came out, restoring himself to Pomponianus and t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

he others who had been unable to sleep. They discussed what to do, whether to remain under cover or to try the open air. The buildings were being rocked by a series of strong tremors, and appeared to have come loose from their foundations and to be sliding this way and that. Outside, however, there was danger from the rocks that were coming down, light and fire-consumed as these bits of pumice were. Weighing the relative dangers they chose the outdoors; in my uncle's case it was a rational decision, others just chose the alternative that frightened them the least. They tied pillows on top of their heads as protecti

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

on against the shower of rock… the darkness was darker and thicker than any night. But they had torches and other lights. They decided to go down to the shore, to see from close up if anything was possible by sea. But it remained as rough and uncooperative as before. Resting in the shade of a sail he drank once or twice from the cold water he had asked for”[44] for escape by sea was impossible due to strong opposing winds.

Continued in Part 3 of 3

_________________________________________________________________

[27]Salvatore Nappo. Pompeii: A Guide to the Ancient City. (New York: Barne

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s & Noble Publishing, Inc., 1998), p. 13.

[28]Dio Cassius. The Eruption of Vesuvius that buried Pompei, “Roman History Epitome of Book LXVI” (A.D. 203) 2 May, 2006. http://penelope.uchicago.edu/Thayer/E/Roman/Texts/Cassius_Dio/66*.html

[29]Bonnie S. Lawrence, Project Editor. Restless Earth. (Washington, D.C.: The National Geographic Society, 1997), p. 191.

[30]The ad79 Eruption of Mt. Vesuvius. University of Michigan. 2005. 30 April, 2006. http://www.windows.ucar.edu/tour/link=/earth/interior/Mt_Vesuvius_ad79.html&edu=high

[31]AD 79 – Vesuvius explodes. 5 of May, 2006. http

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

://www.archaeology.co.uk/cwa/issues/cwa4/pompeii/eruption.htm

[32]Science and geology of volcanos. 8 May, 2006. http://www.channel4.com/history/microsites/P/pompeii/volcano.htm

[33]Dio Cassius. The Eruption of Vesuvius that buried Pompei, “Roman History Epitome of Book LXVI” (A.D. 203) 2 May, 2006. http://penelope.uchicago.edu/Thayer/E/Roman/Texts/Cassius_Dio/66*.html

[34]Rosella Lorenzi. The Long, Deathly Silence. 2 May, 2006. http://dsc.discovery.com/convergence/pompeii/history/history.html

[35]http://www.fieldmuseum.org/pompeii/pompeii2/pompeii_content.html

[36]Dio C

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

assius. The Eruption of Vesuvius that buried Pompei, “Roman History Epitome of Book LXVI” (A.D. 203) 2 May, 2006. http://penelope.uchicago.edu/Thayer/E/Roman/Texts/Cassius_Dio/66*.html

[37]Pliny Letter 6.16. 30 April 2006. http://www.amherst.edu/~classics/DamonFiles/classics36/ancsrc/01.html

[38]Scandone, Giacomelli, and Gasparini. “The 79 AD Eruption of Vesuvius. Journal of Volcanology and Geothermal Research. 1993. 30 April, 2006. http://vulcan.fis.uniroma3.it/vesuvio/79_eruption.html

[39]http://www.fieldmuseum.org/pompeii/pompeii2/pompeii_content.html

[40]Nigel Cawthorne.

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

100 Catastrophic Disasters. (New York: Barnes & Noble Publishing, Inc., 2003) 152.

[41]http://www.fieldmuseum.org/pompeii/pompeii2/pompeii_content.html and Tony Allan. Secrets Of The Ancient Dead. (London: Duncan Baird Publishers, 2004), p. 92.

[42]Pliny Letter 6.20. 30 April 2006. http://www.amherst.edu/~classics/DamonFiles/classics36/ancsrc/02.html

[43]Salvatore Nappo. Pompeii: A Guide to the Ancient City. (New York: Barnes & Noble Publishing, Inc., 1998), p. 13.

[44]Pliny Letter 6.16. 30 April 2006. http://www.amherst.edu/~classics/DamonFiles/classics36/ancsrc/01.html

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice Pool - The End of Pompeii and Herculaneum (August 24-25, A.D. 79) Part 2 of 3

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