50 column results
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  • Gary Hutchinson
    Save Time and Money in Your Cold Chain via Dynamic Stability Testing: Stability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. Temperature-sensitive product may exceed long-term storage conditions established by the manufacturer at any time during manufacturing, distribution, and customer handling steps (e.g. bulk transport, filling and packaging operations, final product distribution operations, end user administration) intentionally (i.e. exposure) or not (i.e. excursion). The allowable time and temperature exposure to ranges outside of the long-term storage conditions for manufacturing is currently justified by using accelerated stability data gathered during static stability studies conducted under ICH guidelines. Read more
     June 15,2015 by Gary Hutchinson
  • Jim Bacon
    The Cold Chain Global Forum – what’s in it for me?: Dear readers and colleagues in the Pharma Cold Chain arena, I am pleased to be initiating a regular article with Cold Chain IQ, discussing the issues, challenges, and opportunities of shipping temperature sensitive pharmaceuticals and biotechnology products throughout the cold chain from manufacturer to end-customers. As many of you know, I will draw from my many years of experience and provide my thoughts and ideas from a manufacturer-logistics perspective in laymen’s terms that make sense to the novice and / or the advanced practitioner. Over the years I have stayed true to my core principles of maintaining product integrity, understanding the value of the partner provider relationship, promoting transparency of information, and the overriding notion that “the whole is greater than the sum of its parts”. Read more
  • Robert Musterer
    WARNING: Buyer Beware: In the last 2 months I have received 3 requests through various networking sites to provide information on particular topics about our industry. In these particular cases, the individuals claim to have global pharma clients seeking assistance with decisions around use of CROs, the selection of EDC systems, and the implementation of CDMS solutions. Most troubling in all these cases is that the questions being asked were extremely basic. Read more
  • Robert Musterer
    I Had a Dream: I’d like to share with you a dream I had the other night, or more importantly the glimpse of insight that I derived from it. In my dream, my son was still in high school, in fact a new freshman. He had participated in the first practice for the soccer team and while waiting for a post-practice meeting to start he was joking with some of his team mates. Apparently this was against some unwritten rule and he was kicked off the team. Read more
     March 23,2015 by Robert Musterer
  • Robert Musterer
    Seems Everyone Is Building Clinical Data Repositories, Now How Are We Going To Use Them?: Whether you call it a clinical data repository (CDR) or a clinical data warehouse (CDW); it seems everyone (oh, all right - at least a lot of companies) are either building, or planning to build one. Most of these companies have grand notions of bringing together data from a wide variety of sources to be able to glean new insights. However the big unanswered questions are; just how are these insights to be gleaned, and who will be doing the searching to glean these insights? Read more
     February 19,2015 by Robert Musterer
  • Robert Musterer
    How Many Strikes Can One Support Request Gather?: The other day I had the dubious pleasure of having the hard drive on my laptop fail. I was fortunate enough that I got a warning message letting me know that something was amiss and had the presence of mind to double check to make sure that I had a backup of everything of concern. In addition to that, I take advantage of one of the cloud based services for email and provision of desktop software. Read more
     January 16,2015 by Robert Musterer
  • Peter Norman
    The Changing Multiple Sclerosis Market: More recently the options available to MS sufferers have been increased by the introduction of three different classes of oral medication, two of which have now proved to be major commercial successes as evidenced by the sales of Gilenya and Tecfidera. Read more
     February 6,2015 by Peter Norman
  • Peter Norman
    The Race to Develop Adalimumab Biosimilars: With a market of more than $10 billion, competition is heating up to get a piece of the world's best selling drug, Humira. In this column, Peter Norman examines the biosimilars currently in trials and looks at the potential impact of these drugs on the vast revenues of this drug. Read more
     November 17,2014 by Peter Norman
  • Cathy Roberson
    Generics Make Their Mark on the Cold Chain: Generic drugs are having a major impact on the pharmaceutical industry. For example, Mexican pharmaceutical industry group, Canifarma, estimates that generic drugs represent about 87% of total drug sales in Mexico, up from 30% in 1997. In Brazil, the percentage is equally as high at 76% and in the US, more than 8 in 10 prescriptions filled are for generic drugs according to the FDA. Read more
     May 11,2015 by Cathy Roberson
  • Cathy Roberson
    It’s All in the Package: The package is one of the most important components in cold chain shipping. According to the 2014 Pharmaceutical Commerce Biopharma Cold Chain Sourcebook, cold chain logistics spending was estimated at $8.4 billion globally. Of this amount, about a third, approximately $2.8 billion, is spent on packaging and instrumentation such as insulated boxes, blankets, active temperature-control shipping containers and various temperature sensors and recorders. Read more
     March 9,2015 by Cathy Roberson
  • Tony Hitchcock
    If Single Use is now the Norm: With single use systems becoming the norm, now is the time that industry must take stock of the situation and assess which are the challenges which may be hindering future progress. In this column Tony Hitchcock looks at these challenges and asks what can we in industry do to overcome them. Read more
     September 18,2014 by Tony Hitchcock
  • Tony Hitchcock
    Where Next for Single Use Systems?: With the on-going maturation of single use systems, one of the growing discussions is on the topic of standardisation. With many companies and organisations being at cross purposes when it comes to these standards, it is up for debate whether standardisation will be possible. In this column, Tony Hitchcock dissects the issues surrounding this topic and asks whether this debate will ever be resolved. Read more
     June 12,2014 by Tony Hitchcock
  • Mark Edwards
    Temperature Controlled Airfreight: Since the introduction of “new” Good Distribution Practice (GDP), there has been a lot of work by airlines to introduce temperature controlled services. There are currently more than 30 airlines who offer a “pharmaceutical” service but not all services are created equally! Read more
     April 10,2015 by Mark Edwards
  • Eric Langer
    Biopharma Suppliers’ Budgets Increase: Bellwether for Better Times: Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts at vendors that started in 2008 have begun to turn around. We measured 10 budget areas for vendors to this industry. Sales budgets, the only area that did not take a downturn, continued to increase, this year, by an average of 5% globally. Read more
     December 15,2011 by Eric Langer
50 column results
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