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Advice Pool - Study Finds Parents In Texas Pass Whooping Cough To Babies
The New York Times reported, in an April 2007 article, that the rates of pertussis, or whooping cough, have been steadily increasing since the 1980s, and a new study by the Centers for Disease Control and Prevention (CDC) reports that infa
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
nts most often catch the disease from older household members, especially infected parents. Adults in Dallas, Houston and elsewhere in Texas, as well as throughout the rest of the country, can transmit the illness without having any sympto
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
s themselves.
There were more than 25,000 cases reported in 2005, the latest year for which there are figures, up from an average of 2,900 a year in the 1990s. The panel that advises the CDC now recommends vaccination for all adolescents
There were more than 25,000 cases reported in 2005, the latest year for which there are figures, up from an average of 2,900 a year in the 1990s. The panel that advises the CDC now recommends vaccination for all adolescents
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nd adults up to 64, and for older people if they have close contact with babies. While the disease is usually mild in adults, it can be fatal in infants.
"The big problem in previous studies was that they looked at those who had symptoms,
"The big problem in previous studies was that they looked at those who had symptoms,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
and then extrapolated from them to people for whom they had no information," said Dr. Annelies Van Rie, the senior author.
"We had information on all close contacts independent of symptoms," Dr. Van Rie said, "and therefore our conclusion
"We had information on all close contacts independent of symptoms," Dr. Van Rie said, "and therefore our conclusion
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
do not have the bias of incomplete information. Our study confirms that parents are an important source for infant pertussis."
Children with pertussis almost always suffer its vivid symptoms -- bouts of violent coughing, followed by gasp
Children with pertussis almost always suffer its vivid symptoms -- bouts of violent coughing, followed by gasp
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
ng for breath with a characteristic high-pitched whoop. Young infants appear especially ill and distressed, sometimes even turning blue as they gasp for air, and then vomiting after the coughing episode. The disease is spread by contact wi
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
h airborne droplets from coughing or sneezing.
The researchers tracked 91 cases of pertussis in infants less than 6 months old in 12 hospitals in France, Germany, the United States and Canada. They also examined 347 of the infants' contac
The researchers tracked 91 cases of pertussis in infants less than 6 months old in 12 hospitals in France, Germany, the United States and Canada. They also examined 347 of the infants' contac
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s, and found that 76 percent to 83 percent of the transmissions to infants could be attributed to a household member. Half the infections were from parent to child.
Dr. Margaret K. Hostetter, who leads the department of pediatrics at Yale
Dr. Margaret K. Hostetter, who leads the department of pediatrics at Yale
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
University, was impressed with the study's methodology and said it reinforced the case for early vaccination.
"Sometimes we think waiting a month or two beyond the appropriate time for the immunization isn't a big deal," she said. "This s
"Sometimes we think waiting a month or two beyond the appropriate time for the immunization isn't a big deal," she said. "This s
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
udy shows that those very early months are extremely important for a baby's protection." Dr. Hostetter was not involved in the study, which appears in the April 2007 issue of The Pediatric Infectious Disease Journal.
The authors write tha
The authors write tha
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
t their analysis benefits from its strong prospective design, in which cases and transmission routes were detected with laboratory analysis. In addition, the study included examination of cases in which there were no symptoms, calling into
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
question the common belief that asymptomatic people cannot transmit the disease.
At the same time, the researchers acknowledge that they were unable to identify a source of infection in a significant proportion of infants, which may sugge
At the same time, the researchers acknowledge that they were unable to identify a source of infection in a significant proportion of infants, which may sugge
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
t that casual contacts outside the family area are also a source of infection.
"Parents play the most important role," said Dr. Van Rie, who is an assistant professor of epidemiology at the University of North Carolina. "But casual transm
"Parents play the most important role," said Dr. Van Rie, who is an assistant professor of epidemiology at the University of North Carolina. "But casual transm
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ssion in the community is not negligible. So the vaccination of adults in the community is important."
The pertussis vaccine now used in the United States for older children and adults is given in a single-dose combination known as Tdap f
The pertussis vaccine now used in the United States for older children and adults is given in a single-dose combination known as Tdap f
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
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
r tetanus, diphtheria and acellular pertussis. There are two versions of the vaccine, one for people 10 to 18, and the other approved for ages 11 to 64.
A stronger dosage of the vaccine, often referred to as DTaP, is recommended for all i
A stronger dosage of the vaccine, often referred to as DTaP, is recommended for all i
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
fants, and is usually given at ages 2, 4 and 6 months with a fourth dose at about 15 to 18 months. A booster dose is recommended at 4 to 6 years, before the child enters school.
"When adults get vaccinated," Dr. Van Rie said, "they protec
"When adults get vaccinated," Dr. Van Rie said, "they protec
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
themselves from a mild disease. But they protect infants from a disease that can be deadly."
What affects your health sometimes affects the health of others. And as you'll discover, what affects your health also will eventually affect yo
What affects your health sometimes affects the health of others. And as you'll discover, what affects your health also will eventually affect yo
.
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
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
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elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
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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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