The appeal of electronic laboratory notebooks (ELN) makes sense when one considers the highly coordinated effort necessary to produce pharmaceuticals. “It’s not any one single group that does all the work, but several different groups operating cross functionally and aiming for a desired patient outcome,” said a principal research scientist of a biopharmaceutical company which recently implemented BIOVIA Workbook. For example, a capsule of drug product contains a combination of one or more Active Pharmaceutical Ingredient (API) and several excipients that comprise the dosage form administered to patients. An effective ELN must be able to easily trace drug capsule or tablet genealogy back to specific API lots and ultimately to the raw materials used to produce each API. Moreover, transforming an API into a successful capsule or tablet that can be tested in the clinic requires discovery, formulation R&D and process R&D to maintain strong connectivity. Several other key disciplines also participate in drug development, including drug metabolism and toxicology, scale-up and manufacturing.
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