PharmaPendium is reducing research time from weeks to hours
According to a leading dermatology company, PharmaPendium has eliminated the need for months of essential research each year. In the words of the company's scientific information manager: "We probably access PharmaPendium between 60 and 80 times a month to compare products that are currently in development and at the lifecycle management stage."
The database gives drug development teams access to regulatory documents, registration dossier documents and entire approval packages. They simply enter the name of a medicine, or its trade name, to view all the related data.
PharmaPendium is used primarily by the development teams – in particular, clinicians doing phase I, II and III studies and dossier submission – to determine which classes of medicines produce particular effects in given situations.
Prior to the introduction of PharmaPendium, the company's developmental clinicians would primarily use Drugs@FDA, a searchable catalog of FDA-approved drug products; however, they did not find everything they needed there or in the other databases they used.
In contrast, PharmaPendium enables regulatory affairs staff and clinicians to quickly and easily access historical approval data to determine which questions the US drug authority posed to other pharmaceutical companies developing similar products.
The benefits to the pharmacokinetic teams have been particularly remarkable. According to a customer the greatest impact of the PK module is on the company's 'licensing in' activity — the assessment of new external opportunities. It allows companies to quickly extrapolate PK data for potential in-licensing products, enabling their specialists to run software models, ensuring more precise estimates.
Clinicians also use PharmaPendium's FDA approval package information when designing clinical studies and development plans. PharmaPendium helps clinicians understand the FDA's requirements and questions and thus saves time.