We 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 [...]
Archive for March, 2009
Botanicals: What is the starting material for the API?
Published March 30th, 2009 in CMC Issues. 0 CommentsNot all clients come to us with product ideas. Indeed, they want us to help identify a short list of suitable candidates. Example companies might include technology platform companies. How do we go about helping these clients? We have a four-step process: Criteria Selection, Criteria Evaluation, Candidate Narrowing, Candidate Selection. 1. Criteria Selection. Every company will use [...]
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 [...]
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. [...]
505(b)(2) Development Risks
Published March 9th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsWe know that 505(b)(2) drug development is chosen because it is lower cost, lower risk and faster than traditional new drug development and offers the potential of greater ROI than generics. But, it is not without any risks. On 3/06/2009, Takeda announced “that although the alogliptin NDA was filed prior to issuance of FDA’s December [...]
Generic Cliff
Published March 23rd, 2009 in News Commentary. 0 CommentsAt the recent Generic Pharmaceutical Association (GPhA) 2009 annual meeting, several presenters discussed what was termed the “generic cliff” – a time in the near future when there will be no small molecules left to copy. According to the CEOs of Watson, Mylan and Teva, this period is 2017-2019. What’s leading people to see the [...]