Navigation Links
New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.

"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."

Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.

While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.

For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications tha t use an alternative, hydrofluoroalkane.

The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.

In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.

Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.


'"/>




Related medicine news :

1. Ultrasound Screening Could Improve The Outcome Of Critically ill Patients
2. Sleep Not Critical For Early Brain Development Of Baby Dolphins
3. Critically Ill Patients More At Risk Of Infection If Glucose Is Present In Their Lung Secretions
4. Dietary supplementation of Folic Acid Requires Critical Evaluation
5. Past President Narayanans Condition Still Critical
6. Critical Decisions Have To Be Taken By Mothers Of Premature Babies
7. Heart Transplant Twin Recovering, But Brother Critical
8. Australia In Search Of A Better Way to Handle Critically Ill Patients and Balance Elective Surgery
9. Yeast Genome Unravels Genes Critical For Maintaining DNA Integrity
10. Drug Trial Goes Foul, Six Volunteers Critically Ill
11. Sensory Input Necessary During "Critical Periods" Of Brain Development
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... or dementia. However, many long-term care insurance companies have a waiver for care if ... the 90-day elimination period, when the family pays for care, is often waived, so ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... 2017  According to the Centers for Disease Control and Prevention (CDC), ... PhysicianOne Urgent Care is helping communities across Massachusetts , ... by offering no-cost* flu shots through the end of the month. ... insurance regulations. ... get a flu shot is by the end of October, according to ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new ... at MIBio 2017 in Cambridge, U.K on ... in biopharmaceutical samples with unprecedented speed and sensitivity while using far ... Membrane Imaging. ... particle analysis system ...
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017 /PRNewswire/ ... health and big data solutions, today announced that its MyDario product is ... your local TV listings for when The Dr. Oz Show airs in ... The nine-time ... month. ...
Breaking Medicine Technology: