Pharma Focus Asia Magazine

Foreword

Clinical Trials in Asia

Overcoming Regulatory Concerns

Housing more than half the worlds population Asia is attracting more clinical trials with rapid patient recruitments The three key clinical development regions in AsiaIndia China and South East Asiaplay a major role in global clinical trials Cost sav..

Strategy

First Compulsory License

Likely to impact the pharmaceutical industry in India

On 9th March 2012 the Controller General of Patents Design and Trademarks of India Mr PH Kurian marked his last day in office with a landmark judgment granting the first ever compulsory license to an Indian generic pharmaceutical company Natco Pharma..

Achieving Greater Efficiency in the Production of Biosimilar Antibodies

The biosimilars market is set to reach more than US20 billion in 2020 and both established biopharma and younger therapeutic manufacturers will play their part in meeting demand Despite growing regulatory acceptance for biosimilars challenges remain ..

Molecular Medicines and Diagnosis

A Snapshot Molecular medicines have revolutionised the treatment and diagnosis of diseases The advent of new genomic and proteomics based tools and techniques offer the opportunity to customise them at individual level The application of omics scienc..

Key Elements of the FDA\'s Draft Biosimilars Guidance

On 9th February the FDA announced publication of its eagerly awaited draft guidance documents for biosimilars For the Asian biosimilar industry this represents the first step towards access to a potentially lucrative new market We review the key elem..

Research & Development

Application of Biopharmaceutics Classification System in Drug Development

Along with Regulatory authorities pharmaceutical manufacturers are also making use of BCS throughout drug discovery and development processes The article talks about the status of BCS and BCSanalogues in AsiaPacific countries the role of the BCS for ..

Good Clinical Practice-Compliant Clinical Studies in China

Since the State Food and Drug Administration SFDA in China regulated the clinical trial industry with an amendment of the Chinese Good Clinical Practice GCP guidance both the quality and integrity of clinical research have improved significantly resu..

Clinical Trials

Overcoming Regulatory Barriers

To Fast-Track Clinical Trials

Asia currently represents some of the fastest growing markets for pharmaceuticals Accessible patient populations coupled with a strong and growing infrastructure for quality conduct of clinical research make Asia very attractive for inclusion in glob..

Manufacturing

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

Pharmaceutical industry has great concern towards impurities due to their adverse effects Regulations alarmed the control of drug substances at lower level based on the threshold of toxicological concern and daily dose Advances in analytical technolo..

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