Analytical requirements for the NDA submission of an oral solution to the FDA are very similar to those requirements for any new drug product. The analytical methods that are used for the testing of an oral solution at the NDA stage of development should be fully validated per the ICH guidelines, Q2A and Q2B, now
ICHQ2(R1) [...]
Archive for the 'CMC Issues' Category
Analytical Requirements for Oral Solutions
Published January 7th, 2010 in CMC Issues and How to:. 0 CommentsDo not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that poor oversight of manufacturing and testing subcontractors will be a concern for the FDA. This concern translates into approval [...]
Comparability Protocols
Published September 10th, 2009 in 505(b)(2) Process and CMC Issues. 0 CommentsWhat do you need to do when you need to change suppliers or manufacturing sites? Among the many choices is a formal FDA Comparability Protocol. Our VP CMC, Lynn Gold explains.
Advance planning can improve the possibility of FDA accepting your proposed change. One alternative that can streamline the process of change and add clarity to the requirements involves [...]
Test Specifications for Stability Studies
Published September 1st, 2009 in 505(b)(2) Process, CMC Issues, How to: and Outsourcing. 0 CommentsPivotal stability programs that are used to generate stability data for NDA submissions are different than research stability programs used to design the drug product, explore packaging configurations, etc. This is common sense, but we have seen instances of pivotal stability programs that have been performed for clients with no defined specifications. A stability protocol [...]
Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities
Published June 26th, 2009 in 505(b)(2) Process and CMC Issues. 0 CommentsCamargo is often called on to write and/or assemble NDAs. When we get to prepare an NDA from the beginning, all of the information builds and the resulting ’story’ is easy for the FDA to understand. Often we are retained to write portions and just insert portions written by third parties. Gaps can ensue. Lyn [...]
Botanicals: What is the starting material for the API?
Published March 30th, 2009 in CMC Issues. 0 CommentsWe typically work with small molecules of synthetic origin, but occasionally are retained to work with products that have active ingredients from botanical (plant) sources. Lynn Gold, our VP of CMC provides the following discussion on how to define the starting material for the Active Pharmaceutical Ingredient (API).
The definition of the starting material for any API is a [...]
One vs. Two batches for single-dose and multiple dose studies
Published March 19th, 2009 in CMC Issues and Formulation Issues. 0 CommentsToday’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 [...]
CMC Bridging Studies
Published March 16th, 2009 in 505(b)(2) Process, CMC Issues and Formulation Issues. 0 CommentsWe 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. [...]
FDA requests melamine testing of ingredients
Published August 7th, 2009 in CMC Issues, News Commentary and Uncategorized. 0 CommentsU. S. government officials both inside and outside of FDA have acknowledged that the Agency currently lacks the resources, both financial and human, to adequately monitor the materials going into products being used in the United States. The answer? In the case of the somewhat notorious contaminant melamine, the answer is to make regulated industry [...]