Drug Development Comments - Focused on 505(b)(2)
A couple of weeks ago I was invited to present at the 2009 Nebraska Research and Innovation Conference. The theme of my talk was “The Case for Improving Existing Drugs”.
There are several factors driving people to the 505(b)(2) development pathway, a couple of which are:
Generic cliff. By about 2017 there will be very few remaining [...]
Today’s posting stems from a client question. The client’s product candidate is an oral product that requires both single- and multiple dose pharmacokinetic studies.
Question: Do companies ever use one pivotal batch for single-dose (SD) study and another batch for the multi-dose (MD) study? What are the pros and cons of doing this?
See the table below [...]
We have discussed bridging studies in this blog before in the context of the phase 1 bridging study to link the safety and efficacy of the RLD to the proposed drig product. So, what is meant by a bridging study for CMC* purposes?During the 505(b)(2) drug development process we often change the formulation, components or API. [...]
Not only pharmacokineticists get to have fun in the modeling sandbox. Chemists and formulators get to have their fun synthesizing data. Let’s use an example of how dissolution data can be used for modeling. The example is taken from a project to develop a oral modified release drug where the RLD is an immediate release [...]
The USP established a new test requirement for control of residual solvents in finished dosage forms. The new test is in the General Chapter <467> “Residual Solvents” [Sorry no link - password protected]. The test became official July 1, 2008. In turn, on August 5, 2008 the FDA issued a draft guidance stating that all NDA and [...]
You have a global perspective and drug development program. You want to conduct studies in the US and an international location. You’re going to use an RLD from Big Pharma - you know, the global giants. The RLD bought in the US and Europe looks the same, even has the same marking. But are they same? [...]
You’re choosing excipients and determining amounts, so you go to the IAG (Inactive Ingredient Guide) look up the approved amounts and you’re good to go. Right?
Maybe not… You need to consider EXPOSURE. Exposure is amount over time. Look at the IAG and determine what products have this excipient/inactive ingredient and compute the potential exposure and [...]
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Risk Evaluation Mitigation Strategy (REMS) for long-acting opioids
Published June 4th, 2009 in 505(b)(2) Process, Formulation Issues and News Commentary. 0 CommentsCamargo is working with several clients in developing better treatments for pain. Unfortunately, the active substances that supress pain also can be abused. The FDA and DEA are trying to find ways to allow access to these medicines while imimizing the inherent risks of drug abuse.
In order to properly advise clients, Camargo attends various industry/FDA [...]