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1 Nov 2022, 8:25 pm
Some key points the Agency shared included the following: Your product is only as good as the process-demonstrate your manufacturing process consistently produces drug product as per your critical process parameters (CPPs) Have qualified potency assay(s) prior to conducting your pivotal study Agency often sees issues when the drug product is put on an expedited manufacturing or an expedited clinical program As the clinical program for the drug product matures, the CMC information should… [read post]
22 Jul 2014, 9:07 am
L.J. 310 (2004), and Jason Shachner, Note, Unwrapped, 24 Health Matrix 345 (2014) (stating that only California and New Hampshire clearly protect the right to produce pornography). [read post]
3 Dec 2010, 8:52 am
Fast forward to today where the talk of the town is predictive coding using the ones and zeros to do the work that a human lawyer currently does (maybe "The Matrix" would've been a better analogy here). [read post]
20 Feb 2012, 6:24 am
The role of IP in such a matrix may also take on a distinct meaning. [read post]
8 Dec 2010, 2:20 am
(America-Israel Patent Law) Ziagen (Abacavir) – US: Mylan’s Matrix receives tentative FDA approval under PEPFAR for Abacavir Sulfate tablets, 60 mg (SmartBrief) [read post]
10 Sep 2010, 11:06 am
To file a case, only the petition and a mailing matrix (mailing list of creditors and parties) needs to be filed. [read post]
12 Mar 2007, 9:44 pm
The clients are absolutely reasonable in their perception that most lawyers have no concept of the risk/reward matrix that forms the basis for business decisions. [read post]
16 Jun 2014, 4:00 am
Use the Prioritization Matrix to determine if the effort is worth the potential return. [read post]
26 May 2016, 4:45 am
Once risks have been ranked, the Guidelines suggest plotting the risks on a matrix that gauges the risk severity level against the likelihood of the event occurring. [read post]
22 Feb 2021, 2:53 am
Robbie Stern is a trainee at Matrix Chambers [read post]
31 Oct 2008, 11:53 am
You can separately subscribe to the Pharma & Biotech edition of the IP Think Tank Global Week in Review by subscribing by email, or selecting ‘all posts’ or ‘Pharma, Biotech & Chem’ for the RSS option at the Subscribe page: [duncanbucknell.com] Highlights this week included: Oxytrol (Oxybutynin) - US: Watson files patent infringement lawsuit against Barr over application to market generic Oxytrol; Barr challenges Oxytrol patent… [read post]
20 Nov 2008, 8:29 pm
Alex Brill is CEO of Matrix Global Advisors, LLC, and a research fellow at the American Enterprise Institute. [read post]
3 Nov 2014, 2:15 am
Ayesha commenced traineeship at Matrix in October 2014. [read post]
20 May 2020, 10:09 am
In a bit of an oddity, Federal Circuit’s opinion actually uses vector in the computer science form — noting that the accused process “stores information, whether as a 4×4 matrix or as an equivalent 16-term vector. [read post]
21 Jun 2011, 1:34 pm
Understanding the Matrix of Relationships Before putting in some knowledge systems, you need to understand the relationships among the firm, the partners, the clients and the formal/informal groups within the firm. [read post]
16 Jan 2010, 4:45 am
The report includes the minutes from the four quarterly meetings, including this interesting passage from the first quarter meeting where then-ASAP-member Bolden is talking about risk, safety, and communicating those issues to the public: General Bolden digressed to talk briefly about four overriding themes, specifically (1) foremost, a determination of how safe is safe enough; (2) the timing of NASA involvement in the Commercial Orbital Transportation Services (COTS) Program and in specification… [read post]
23 Sep 2011, 7:08 am
Madsen referred to the “verbal report” as being “sufficient for the purposes of handling the claim SHORT OF LITIGATION” (emphasis mine). [12] In early 2011 defence counsel commissioned MEA to prepare an expert report, apparently regarding the seatbelt issue, for possible use at trial; he says that since such a report has now been requested, the engineer’s file material, notes and such are not producible unless and until the report is received and provided to… [read post]
30 May 2012, 5:52 pm
Pre-testing issues Collection tubes and directions The laboratory Personnel Testing Specimen suitability for testing Analytical methods—calibration Validation and approaches to calibration Quality control and matrix validation Batch analysis Quality control Acceptance criteria Monitoring quality control performance Instrument maintenance Proficiency tests Post testing Reporting Uncertainty Records and specimen retention That’s the outline from Chapter 9 of… [read post]
29 Apr 2007, 9:49 pm
But if the search actually uncovers evidence of criminal wrongdoing, proving objectively that it was justified at least in one narrow sense, then we need to subject it to closer scrutiny.Under my Plan™, American courts would adopt a decision-making matrix in the form of an ever-expanding flow-chart with approximately 4,000 boxes. [read post]
15 Jun 2014, 5:03 pm
A careful management of time by agenda or Eienshower Matrix, will integrate personal life with work schedule. [read post]
