Pharma Focus Asia Magazine

This Healthcare Magazine is the source for a plethora of unique Healthcare articles. Several notable figures in the medical industry, from top med schools and hospitals are featured in the Medical Sciences section, with their expert knowledge of the field.

Manufacturing

Recent Advances in Analytical Methodologies for the Determination of Impurities in Drugs

Safety and efficacy of pharmaceuticals are two fundamental issues of importance in drug therapy The safety of a drug is determined by its pharmacologicaltoxicological profile as well as the adverse effects caused by the impurities The impurities in drugs often possess unwanted pharmacologicaltoxicological effects by which any benefit from their adm...

Clinical Trials

Overcoming Regulatory Barriers

To Fast-Track Clinical Trials

The last decade has seen a significant increase in the number of global clinical trials being conducted in Asia In China and India the number of new global studies approved rose from less than in each country in to more than in India and to more than in China in This growth is due to a number of factors which have aligned to make Asia an attr...

Research & Development

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...

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...

Strategy

Key Elements of the FDA\'s Draft Biosimilars Guidance

On th February The US FDA announced the first three of the eagerlyawaited draft guidance documents for biosimilars followon biologics Biosimilars Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Quality C...

Molecular Medicines and Diagnosis

The patient and physician relationship involves a number of steps such as the advice on hygiene maintenance chronic or nonchronicinfectious disease diagnosis measures to limit the spread of disease continuous requirement of diagnostic tools techniques and diagnostic centres pharmacy disease monitoring process and data management obedience of statut...

Achieving Greater Efficiency in the Production of Biosimilar Antibodies

Biosimilars and biobetters represent a new and exciting market for therapeutic manufacturers Recent reports indicate that the market for biosimilar monoclonal antibodies MAb will reach more than US billion in with the majority of revenues coming from established markets for MAbsnamely the USA France Germany Italy Spain the UK and Japan Additional...

First Compulsory License

Likely to impact the pharmaceutical industry in India

The grant of compulsory license CL to Natco Pharma in relation to Bayer Corporation Bayers patented anticancer drug Sorafenib Tosyalte sold under trademark NEXAVAR Drug is expected to have a major impact on the strategies devised by both generic and innovative companies Since this is the first time that the CL has been granted in India several issu...