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2004

Volume 2, Issue 6



GMP Compliance In Europe


It’s no longer business as usual for suppliers of active pharmaceutical ingredients in Europe. New Good Manufacturing Practices will impact API manufacturers who want to conduct business in the European Union.


Tom Branna



Why Effervescence In Pharmaceuticals?


Effervescence is the method of choice when formulating active ingredients with poor solubility. Sodium glycine carbonates are versatile carriers of carbon dioxide in pharmaceutical effervescent applications.


Stefan Vandenberghe



Nanocapsules Offer Limitless Possibilities


For effective drug delivery in a host of applications, chemists should consider this technology to deliver a wide array of active pharmaceutical ingredients.


Nilish V. Patil



Volume 2, Issue 5



Quality eCTD Submissions


For successful transition from paper to e-submissions, the scientist and the information systems professional need to understand each other's tasks and responsibilities


Sidney B. Rubinstein, James E. Carter, and Jeffery L. Carter



Stem Cell R&D: In Need of Global Harmonization


Deborah M. Shelton, Esq



A Look at the Industry Leaders


Here are the top 10 companies, based on sales, in the pharma, biopharma and generic segments


Tom Branna



Volume 2, Issue 4



Fine Chemicals Revisited


Despite enormous changes that have taken place during the past few years, finding a supplier who is committed to the pharmaceutical industry is more important than ever


Guy Villax



Statistical Applications for Formulation Chemists


Technical service scientists can rely on statistics for optimizing formulations and processes, while minimizing experimentation


Adolfo Gomez



Made to Order


For pharma and biopharma companies, there is more emphasis on discovery and less emphasis on adding resources to support product development. That creates the perfect environment for custom manufacturers to thrive.


Ed Kensik



Volume 2, Issue 2



A Strong Challenge for Brands


Patent expirations, cost-cutting initiatives and regulatory reform boost prospects for generics.



Biogenerics in the U.S.


FDA is trying to determine if it is possible to approve a biogeneric in the absence of full trial data.



PAT: The Excipient Industry View


Process Analytical Technology could have big impact on suppliers and their customers.



Volume 2, Issue 1



Molecule-based Analysis: Mapping Fine Chemicals


Information generated from this process can provide greater insight into the complex world of fine chemicals.


William B. Armiger and Larry Drumm



The Fine Chemical Industry: Fine Mess of Fine Opportunity?


Companies must break old paradigms to succeed in the changing pharma landscape.


Enrico Polastro



Effective API Sourcing in Generics


The successful sourcing team must possess and apply a broad working knowledge of all functions within the generic business.


Ambrose Stafford