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Managing the Drug Development Process reference guide

Bringing a new therapeutic to market? Do so more effectively with our reference guide; designed from both a regulatory and drug development perspective. Assess what is required on the critical path to market before you file for your IND, NDA or BLA.

Strategies for Choosing an Outsourcing Provider

Today pharmaceutical companies have many choices, when electing an outsource provider. Drug developers may find it difficult to identify a single provider with a list of services, which meets all of the client’s requirements. Specialization or limitations at the provider’s site may require that pharmaceutical developers obtain services from multiple sources. Select service providers have expanded their offerings to include: research, manufacturing, analytical services, quality assurance and regulatory compliance. While no one provider may offer all the possibilities required, the developer must focus on a provider’s capabilities, resources and expertise during the selection process.

Successful Stability Testing Strategies

Properly planned, executed and managed stability studies are critical to understanding the data generated during clinical trials

The approval of a drug for the marketplace hinges on the success or failure of the required human clinical trials. Also critical to a drug’s approval is a clear understanding of its stability, both as an active pharmaceutical ingredient (API) and as a finished drug product (FDP).

As with clinical trials, it is imperative to properly plan, document and manage stability study programs and cycles. There are many items to be considered in that planning which, if addressed correctly, can result in reliable information-rich data or, if overlooked, may result in an investigation and/or jeopardize drug approval.

Strategies for Optimizing CGE Methods for the Analysis of Oligonucleotides