Research & Development
Multi-functional Nanomedicine
Technology convergence in development of targeted therapeutics
In the context of biomedical imaging and therapeutic applications nanosystems are defined as particles of less than nanometers in diameter that can overcome biological barriers and provide efficient delivery and have unique properties The application of nanotechnology for disease prevention diagnosis and treatment is receiving significant atten...
Novel Genetic Vaccines
A key focus area
Edward Jenners work in developing the worlds first smallpox vaccine in the s demonstrated that it was possible to protect the general population from major threats to public health and vaccine development aimed at combating the major concerns of the day has continued ever since There have been many successes and vaccines are now available to immuni...
New Drugs in Japan
Conditional authorisation
The challenge to ensure early access to new drugs and their safe launch is growing globally particularly after a number of large scale Adverse Drug Reactions ADRs were identified and attracted much attention from public and blockbusters were withdrawn from the market US FDA intensified its authority of managing postmarket safety of new drugs but th...
Mitochondrial Nanomedicine
Tailored and efficient therapeutics
Significant progress has been made in elucidating the central role of mitochondria in influencing the life and death of a cell Yet effective therapies for mitochondrial diseases remain elusive However the ongoing merger of nanoscience with mitochondrial medicine gives rise to novel strategies for diagnosis and therapy of mitochondrial disorders...
Oral Inhalation Technology
Impact of nanotechnology
The FDA announced in August that it will form an internal FDA Nanotechnology Task Force The group responsibilities will be to establish regulatory approaches in the development of safe and effective FDAregulated products that use nanotechnology affecting virtually every product category that FDA regulatesfrom pharmaceuticals and devices to cosmeti...
When medical need is not matched by market opportunity
There is an urgent need for new drugs to treat tropical parasitic diseases like malaria leishmaniasis trypanosomiasis and schistosomiasis These diseases affect hundreds of millions of people and are major contributors to mortality and morbidity in the developing world Malarial disease caused by the parasite Plasmodium falciparum is responsible f...
Natural Products in Drug Discovery
Natural products particularly microbial and plant products in their native form have been associated with mankind since ancient times These have played a vital role in the discovery of New Chemical Entities NCEs in the golden period of drug discovery Drugs derived from natural sources also served as drug leads suitable for optimisation by syntheti...
Application of Biopharmaceutics Classification System in Drug Development
Since it was introduced in the Biopharmaceutics Classification System BCS has had a major impact on the regulation of oral drug products worldwide Fundamentally the BCS is a scientific framework for classifying drug substances ie active ingredients based on the factors that determine the rate and extent of absorption from immediate release IR soli...
Good Clinical Practice-Compliant Clinical Studies in China
Beijing China Since the s Good Clinical Practice GCP has made its way to China through international academic communications and exchanges as well as through investments of many multinational pharmaceutical companies in China resulting in the increase of clinical trials With the growing globalisation of the economy in the s more and more pharmac...
Drug Research and Development
Bridging the innovation gap
Many think that may be regarded as the year that Big Pharma went beyond merely embracing biotechnology but decided that consolidation with its biologics breathren may well be the answer to the many problems currently plagueing them Over the past couple of decades Big Pharma has consolidated with other Big and midsize Pharma companies in a so calle...
