Let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.
The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower prices.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
Biomanufacturers, especially those facing the debut of biosimilars in core markets, have an urgent imperative to reduce manufacturing costs via increased productivity and yields. In turn, this drives a wide range of business decisions, including capital investment, process choices and design, and equipment selection. Learn how AlphaMab Co. Ltd, a fast-growing bio-developer and producer, cut scale-up time using a Quality by Design (QbD) approach.
In recent years there have been several potentially life-saving medications approved for cancer treatment, including targeted molecular entities and biologics such as Opdivo (nivolumab) and Keytruda (pembrolizumab). Oncology drugs remain a pharmaceutical priority and investments into cancer account for 30% of all pre-clinical and phase 1 clinical development expenditures. There is an impressive list of close to 800 drugs and vaccines currently in the industry-wide development pipeline, many with promising results in early-stage clinical trials. However by historical measures only 10% or fewer of these drugs will ever make it through FDA approval and become part of routine patient care.
Seeing is believing – this is an important aspect of Tissue Phenomics, where cellular structures in tissue slides taken from patients are investigated in real space. Observing directly what type of structures form and what kind of interactions take place is in general of much higher value than concluding indirectly from other type of data. I experienced this factor very clearly thirty years ago when people speculated about the atomic structure on the surfaces of matter from indirect measurement.
As healthcare continues its transition towards precision medicine, physicians are eager to maximize both the quantity and quality of data obtained from their patients’ tissue samples. In the current “one drug, one test” paradigm, physicians struggle to balance the number of tests required to make a treatment decision with the limited amount of tissue that is available.
Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.
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