Whitepapers
Pharma white papers on contemporary issues, technologies, research, etc. are presented in this section to enable the readers with rich information and knowledge. This section provides white papers related to all the spheres of the pharma industry.
Meeting Current and Future Serialisation Challenges: An AESICA White Paper
Summary Serialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another Several countries including China South Korea Turkey Argentina and Brazil already have regulations in place that must be complied with whilst many others including countries i
The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing: A Lachman White Paper
Summary Every business faces risk Broadly speaking the primary categories of business risk are Market Financial Execution and Regulatory Successful companies have developed a core competency in managing for these risks turning risk management into a sustainable competitive advantage For drug manufacturers recent trends have underscored the importance o
Indication-Specific Pricing Of Pharmaceuticals In The United States Health Care System: An ICER White Paper
Summary The Institute for Clinical and Economic Review ICER held a Policy Summit on December with health care leaders from the payer and life sciences organizations that comprise the ICER membership group The purpose of the meeting was to explore the potential value of indicationspecific pricing ISP of pharmaceuticals for both pay
How to Choose the Right Contract Manufacturing Organisation for Your Pharmaceutical Product: A Burrard Pharmaceuticals White Paper
Summary Contract manufacturing can enhance the drug development process by creating effective processes increasing manufacturing efficiencies and reducing overhead costs Selecting a CMO with two essential characteristics capability and partnershipchemistry is often difficult and challenging This white paper contains an allinclusive tenstep guide for s
Getting Serious About Serialization—A Comprehensive Look At The Legislation Shaping U.S. Pharmaceutical Supply Chains: An MD Logistics White Paper
Summary The World Health Organization WHO defines a counterfeit medication as a medication that is deliberately and fraudulently mislabelled with respect to identity andor source According to WHO counterfeiting can apply to both branded and generic products and can include products with the correct ingredients without active ingredients or with fake packaging
IT Trends in Indian Pharmaceutical Industry: A Techwave White Paper
Summary The Indian pharmaceutical industry is today the fourth largest globally in volume terms and th largest in value terms and continues to grow annually at The industry is making significant IT investments to support this growth This paper surveys the IT usage in the Pharma industry It describes the opportunity
Streamlining Distribution In The Pharmaceutical Industry: A TCS White Paper
Summary The healthcare value chain is evolving into an interconnected and cost effective model where pharmaceutical companies will focus on and invest in securing distribution management as well as complying with emerging regulations Reimagining business relationships with thirdparty service providers involved in packaging labelling distribution
505(B) (2) Drug Development Pathway: A Within3 Whie Paper
Summary The b regulatory pathway is one of three categories of new drug applications NDA While the application requires full safety and effectiveness reports it gives the FDA permission to use data not gathered by the NDA applicant avoiding unnecessary duplicate analyses Employing a b regulatory strategy can offer significant benefits e
Overcoming Technical Challenges In Cell-Based High Throughput Screens: A Roche White Paper
Summary Tremendous technological advancements in automated biotechnology and combinatorial chemistry have led to the widespread implementation of high throughput screening HTS for drug discovery since the early s However the drug discovery process is a long and costly journey often requiring many years and millions of dollars to reach the market
The Effect Of Silicification On The Roller Compaction Performance Of Microcrystalline Cellulose: A JRS Pharma White Paper
Summary Roller compaction or dry granulation is a manufacturing method for pharmaceutical and nutraceutical tablets that continues to gain importance In order to achieve the desired granule properties it is vital to use efficient binderfiller systems which enable easy compaction reproducible grinding results and high recompactibility during the final t
