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.
Cyclodextrins as a Solubilization Tool for Insoluble APIs
One of the main challenges in drug delivery is to guarantee the bioavailability of the active ingredients especially when they are poorly soluble See how to find the right solubilization tool
Rx-360 White Paper on Traceability Data Exchange Architecture
With the quickening pace of global pharmaceutical regulatory drug serialization and traceability mandates the Rx Traceability Data Exchange and Architecture Workgroup TDEA began its activities in August of hosting a series of weekly conference calls to gather information and opinions from participants on supply chain data architecture and choreography models This white paper is the first step in...
Proposed new ICH and USP methods for elemental impurities: The application of ICP-MS and ICP-OES for pharmaceutical analysis
The United States Pharmacopeial Convention USP in parallel with the International Conference on Harmonisation ICH is developing new methods for inorganic impurities in pharmaceuticals and their ingredients The current USP method heavy metals limit test is acknowledged to be inadequate and is due to be replaced with new General Chapters USP Limits and Proc
Key factors in the choice and development of a cleaning strategy - Fedegari Autoclavi SpA
Many aspects need to be considered in setting up a cleaning procedure This is certainly a multidisciplinary issue that involves various company areas from Regulations to Engineering from Quality Control lab to Production department Contributions of all these areas together can lead to a robust and reproducible cleaning process
The Economic Viability of a U.S. Biosimilars Industry
Drug manufacturers have recently begun submitting biosimilar applications to the Food and Drug Administration FDA leading many to believe that a robust US biosimilar industry and substantial health savings are right around the corner In this paper I present an empirical assessment of the viability of biosimilars in the US market and caution against such optimism given biosimilars considerable deve
Supplier Diversity in Pharmaceutical R&D
Procurement decisions are no longer limited to cost savings quality and time sustainability is the new addition to procurement decision making Risks arising from environmental and social factors compliance value creation and external demand are driving sustainable procurement Supplier Diversity an aspect that impacts the sustainability of procurement has gained much importance today This whitepape...
Destination India: Reconfiguring Gelatin Value Chain
Bovine Gelatin Industry Overview The global gelatin production in was thousand tons which is expected to grow at a CAGR of till Globally of gelatin is bovine bone based The yield conversion factor from bovine bone chips to gelatin is Bovine bone chips are widely used to manufacture pharmaceutical gelatin since it is more preferred due to its encapsulation properties and higher bl
Crippled by Cost? CMO Quo Vadis
Introduction The global CMO market is said to reach USD billion by Patent expiry of drugs stringent price regulations especially in Europe US to purchase drugs from pharma companies Government budget cuts for pharma RD these are the forces which are expected to reshape the future of pharma and the CMO industry At least manufacturing facilities owned by pharma companies were shut dow
Driving Transformation Through Integrated Multichannel Marketing
Background Over the last few years the pharmaceutical industry has undergone a dramatic transformation including LoE RD productivity challenges regulatory hurdles reimbursement pressures and changes in the macroeconomic environment Implementing JIT labeling and packaging process effectively can potential
Impact analysis of Just in Time packaging and labeling on clinical supply chain
Abstract Clinical supply chain is in intense pressure for better management due to factors like globalization of clinical trials and increase of triple blinded clinical studies Traditional supply chain practices dont allow room for flexibility in shipments for medication kits as they are packaged and labeled in central depot This has led to an increas
