References - Travel and Leisure

The Philippines is the third largest Roman Catholic country in the world with some 80% of the 85 million Filipinos following the faith. The major events in the Christian calendar, Christmas, Easter, All Saints D

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

ay, are all celebrated with gusto but it is Easter or Holy Week, as it is known in the Philippines, which ignites the Filipino passion. From the public self-flagellation and crucifixions of Pampanga Province to

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

Examples of combination products may in

he street parades and the shrines of Makati City’s Poblacion suburb with their infusion of popular and indigenous cultural influences, Holy Week is the celebration of the calendar.

For over half a century, the

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

17000 residents of this suburb have held street parades, a Saturday night, Sunday morning vigil or salubong and constructed shrines in honour of Holy week. Each year up to 40 shrines are dotted about the one squ

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

re kilometer that is the inner city suburb of Poblacion. Throughout the year, street groups known locally as Samahans have raised the 50,000 pesos required to employ an artist, feed and water the volunteer assis

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

Combination pro

ants and obtain the materials necessary to actualize the artist’s vision for their shrine.

These shrines are folk art of the first order, utilizing a range of materials from the time honoured papier-m?ch? to th

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

e 20th Century’s set builder’s material of choice, polystyrene. When they are combined with bamboo, plywood, timber, bricks and mortar that call on the trade skills of the residents and the artist’s skill with t

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

e brush they produce settings worthy of an off Broadway production.

In the weeks leading up to Holy Week, streets become impassable to vehicles as the construction takes place. Scaffolding is erected, frames ar

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

built and clad, sculptures several meters high are constructed, water features are incorporated, lights are installed with the chosen street corners becoming beehives of activity. As the start of Holy Week arri

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

ves the activity goes up a notch, the shrines must be completed by Wednesday evening.

Its arrival heralds a street parade which wends it way through the suburb incorporating every shrine in its route. The devou

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

carry crucifixes for installation in the shrines accompanied by the Makati City Marching Band. It is now that Christ’s Pasyon, the marathon chanting or singing of the poem of Jesus' life, passion, and death beg

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

Following aspects would a

ns and continues day and night through to 3pm on Good Friday.

The Thursday before Good Friday sees thousands of people from all over Metro Manila descend upon the suburb. They wander the streets admiring the di

dd to the challenges in developing combination products:

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

versity of the art created by the Poblacion residents. Although sacred in inspiration, the designs of the shrines are often unconventional ranging from the American Wild West to the pharaohs of ancient Egypt for

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

their chosen themes. There is carnival atmosphere in the air as excited children run and point, adults ooh and ah, street sellers hawk their wares and camera flashes bounce off the walls of the shrines.

Through

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

ut Good Friday Christ’s Pasyon is recited by members of the street associations, usually working in pairs. Church goers wander home from their devotions stopping to listen and gossip at the shrines. At 3pm, the

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

reputed time of Jesus’ death, black shrouds are draped over the crucifixes in the shrines. In the evening a parade of the shrine’s tableaux traverses the streets of the suburb.

After Saturday’s midnight mass, a

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

Professional from academic institutions, pharmaceutical industries, health care indust

the local parish church of Saint Peter and Paul, effigies of Jesus and Mary are carried along different streets to meet for the Salubong outside the suburb’s sports complex. There, a temporary stage has been er

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

cted upon which a choir of children dressed as angels await their arrival. The statue of Mary has her head shrouded with a black cloth and before a crowd of several thousand people packed into this town square,

.

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

it is removed when she meets her son. Blue and white helium filled balloons bare her shroud into the dark heavens above.

Eight to ten hours after this two a.m. meeting, many of the shrines are builder’s rubble.

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

Companies that provide selfless information through particip

They have had their 4 days in the sun and over the following few days any trace of their existence will have vanished except perhaps for a painted section of road way and the record captured by the photographers

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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