Jan 28, 2004
Greetings
Many of you heard of us this week at Barnett's "Dissolution, BioEquivalence and BioAvailability" conference. Please come back weekly, and keep informed with other scientist in the dissolution field.
Book of the Week
While even the best analytical techniques cannot rectify problems generated by sloppy sample preparation, this less "sexy" step between the point at which analytes are transferred from the sample matrix to a form suitable for analysis is often overlooked. With chapters ranging in content from the extraction of organic analytes from liquids and solids to post-extraction procedures and specific applications, Sample Preparation Techniques in Analytical Chemistry addresses all aspects of sample preparation and takes its place in scientific literature as the only text entirely devoted to teaching and reinforcing this crucial process.
Have You Seen the Proposed New General Chapter?
This is circulating around the dissolution world. It is the proposed new general chapter on dissolution. Have you read it yet? <1092> The Dissolution Procedure: Development and Validation. This new general information chapter previewed here is intended to address several issues. Aspects of method development are mentioned only superficially in the current general information chapter In Vitro and In Vivo Evaluation of Dosage Forms <1088>. This previewed chapter goes into greater detail and gives guidance to the analyst on developing meaningful dissolution methods. Similarly, the general information chapter Validation of Compendial Methods <1225> only touches on the special considerations for validation of dissolution testing, whereas this previewed new chapter provides a typical detailed step-by-step approach for designing and validating a dissolution test. Lastly, the previewed chapter gives guidance to the analyst on validation and the use of new technologies and equipment in dissolution testing. This new informational chapter is loosely based on a stimuli article, A New General Information Chapter on Dissolution by Gray VA, Brown CK, Dressman JB, and Leeson LJ that appeared in PF 27(6) [Nov./Dec. 2001]. This article was revised on the basis of comments from industry, the FDA and other regulatory bodies, and the USP Expert Council and its Committees. Readers are encouraged to send their comments concerning the format and the contents of this previewed information chapter to William Brown.
Welcome to Our Newest Advertiser, AAPS
We want to welcome AAPS who have recognized this site as the place to advertise their upcoming Dissolution Workshop. Please plan to attend on March 29-31. I'll be there with Vivian, and many other top dissolution scientists. Please support this site by clicking on their ad on the right.
DDG Software Update
The DDG has updated to vBulletin Version 3.0.0 Release Candidate 3. This newer form of the software is faster and sleeker. Thumbs up from DSN for keeping current with the latest software available. The one downside is that the latest update gives up on the liquid design which stretches full screen. I have a large white column on each side of the screen.
"If you have registered for the DDG Bulletin Board and can not post, please ensure you have activated your account. The activation link is sent to the E-mail address you provided during registration. If the activation process is not working, please E-mail their moderator. You will not be able to post until you are registered and your account is activated. Users submitting false E-mail addresses or E-mail addresses with typos will not be able to post. There is no way around this."
Is Your Lab Making You Sick?
"Epidemiologists identify occupationally-caused disease by determining if there were significantly higher rates of specific illnesses among workers than in a comparable group of persons. More refined epidemiological analysis would identify higher rates of the specific disease among workers more highly exposed, an observation that would further advance the argument for causality. Absence of elevated cancer (or other disease) rates in workers suggests the lack of a causal relationship...more"
Dissolution Method Development and Validation
Have you signed up for the Method Development and validation Course on February 18 - 19 in Cary, North Carolina? It's Varian latest course. Dissolution Method Development and Validation is an intensive two-day course for the experienced R&D, method development, or QC chemists interested in the development and validation of discriminating in vitro dissolution methods. This course will provide an interactive approach to the selection of a discriminating method, including discussion of biorelevant media and test conditions and an examination of appropriate testing equipment.
New advancements in non-compendial apparatus and automated equipment (including Fiber Optics) in regards to innovative method development are also explored. The Biopharmaceutics Classification System will be an integral part of the method development aspects.
Accompanying these topics are presentations of regulatory guidelines for concise method validation and instructional exercises designed to enhancethe student’s learning experience. Participants will be encouraged to share their method development experiences and problems.
Angry Lab Coworkers
A few years ago the Duke University student newspaper, The Chronicle, published an article on undergraduates working in scientific research. One such student, employed in biomedical research as I recall, was quoted as saying, "In my job, I work with rats."
This provoked a letter to the editor signed by all his coworkers in the lab and protesting that "we are NOT rats, and even the one of us who is doesn't like to be reminded of it!"
Jan 21, 2004
Welcome back to the latest installment of the Capsule...
HPLC WEB
HPLC portal - a categorized directory of links, news, education, reference, training, HPLC columns and equipment
The Personal Agenda Planner, PITTCON 2004
Have you ever been overwhelmed by the vast number of events at Pittcon? The Agenda Builder is your personal PITTCON scheduling assistant. It’s a multi-functional, online tool that allows you to make the most of your time at PITTCON by creating a personalized schedule from categories such as Short Courses, Program Sessions and Exhibitors. Meeting an important potential client for lunch or have to make an important phone call? Add it to your agenda by clicking My Events.
With Agenda Builder you can:
View the entire Technical Program including abstracts
Display a list of all exhibiting companies and view the product descriptions
View the extensive list of Short Course offerings
Create and print your personal agenda of program sessions, short courses, exhibit booths and meetings
Pharmaceutical Joint Ventures Slash R&D Costs and Shorten Development Timelines
"Drug companies must pursue more R&D partnerships and other joint ventures to reverse the trend of rising R&D costs and shorten new drug development timelines. Small and medium-sized pharmaceutical and biotech companies are fertile ground for new drug discovery and development, and they must work closely with the industry's leaders to commercialize their products...more"
The Brainteaser
Here are some of the replies to Russ Swan's puzzle that he posted. (see last week's column)
Typical of these was Ralph Hindle of Access Labs in Calgary, Canada: "...the dog's speed is going to max out at his physical capabilities... But if he's like my dog, he'll lose interest and slowly trot in at about half the speed it started out at.... And since the lab tech is busy, that means everyone is in a rush, so of course everything takes twice as long as planned... the pristine samples that were put carefully into the box will arrive, smashed to bits, at 0.5m/sec, although probably at the wrong lab. Damn dog."
A special mention must go to my old friend Charles Pascal of AlphaLabs, for submitting three possible answers (1 m/sec as the box is attached with a short string and thus never reaches the ground... zero as the lab has stone walls and the dog is not armour piercing... and 16,777,216 m/sec and a headache) - all of which were wrong.
The first correct answer, and also the funniest, came from Bill Larsen: "The dog can finally relax when his speed reaches the speed of sound, I know this 'cause when I was I bad kid, I did it to a cat with a pebble inside a coffee can. Except I heard this long doppler stretched "MEEEEEEE E E E E E E O O O O W"
A slightly more complete answer comes from James Docherty at TRW Automotive: "...After 11 seconds, the dog is travelling at 512m/sec. The sound barrier has been broken and therefore the dog cannot hear the box. Personally I'm worried what a supersonic dog could do, and also how the lab staff would stop the dog. Some form of hook, like aircraft carriers? Or perhaps airbags, although they take about 50ms to inflate, so the dog would have covered another 25m. That must be a fit dog, is it fed on Pedigree Chum?"
Poetry Corner
Little Willie was a chemist.
alas he is no more.
For what he thought was H2O,
Was H2SO4.
Until next week, be sure to come back every Wednesday, and get your once a week capsule.
-Pete
Jan 14, 2004
Book of the Week
Let's start this week with a book: Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance. The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States.
Brainteaser
Russ Swan, Editor of LaboratoryTalk recently wrote a Brainteaser in his column. I'd like to restate his puzzle here. It goes something like this.
An overworked laboratory technician uses his dog to deliver samples to the lab, which is exactly 4095m away. He does this by attaching a small sample box to the dog's tail with a short string.
During the run, the box bounces against the ground at a frequency of 1Hz. The dog, a timid creature, starts with a speed of 1m/sec. Being of a nervous disposition, he doubles his speed every time he hears the box hitting the ground. What is his speed when he arrives at the lab?
No prizes I'm afraid, except the inestimable pleasure of solving a puzzle which is not as straightforward as it may first appear. The first and funniest correct answers received will be mentioned, along with the solution, next time.
Are You Getting the Most Out of Your HPLC Column?
Here's a useful article for all those involved in HPLC finish.
RULES OF THE LAB
1. When you don't know what you're doing, do it neatly.
2. Experiments must be reproduceable, they should fail the same way
each time.
3. First draw your curves, then plot your data.
4. Experience is directly proportional to equipment ruined.
5. A record of data is essential, it shows you were working.
6. To study a subject best, understand it thoroughly before you start.
7. To do a lab really well, have your report done well in advance.
8. If you can't get the answer in the usual manner, start at the answer and
derive the question.
9. If that doesn't work, start at both ends and try to find a common middle.
10. In case of doubt, make it sound convincing.
11. Do not believe in miracles---rely on them.
12. Team work is essential. It allows you to blame someone else.
13. All unmarked beakers contain fast-acting, extremely toxic poisons.
14. Any delicate and expensive piece of glassware will break before any use
can be made of it.(Law of Spontaneous Fission)
Saying of the week
Finally, until next week: If you know what you're doing, how long it will take, or what it will cost,
it isn't research. -Pete
Jan 7, 2004
I want to wish a happy new year to everyone. Thank you for your continued support over the past year. So would you like to take a trip back in time?
Dissolution Apparatus Patented
Look how far we've come from this model of dissolution apparatus. It still has a flat bottom, but it does do autosampling! Check out the funny propeller.
How about some guidelines?
From 1978...
Do you remember these events?
Welcome to the Eighties...
Back to the Future
That's enough reminiscing. I've been exploring hardness testing lately. Some of the units that are used are rather strange. How many Strong-Cobbs of force is that? Do you prefer kiloponds or kilograms of force? How much work was done to crush that tablets? Now is work in joules, newtons, or watts? Have you ever found yourself looking for a conversion factor, or even a definition of various units? How many Kiloponds in a Newton? Try this handy site. Just click on "K", look up Kilopond, and find out. Let's see, can I convert Grams per Liter to Troy Ounces per Hogshead...
Fundamentals of Dissolution
Are you looking for a good course to attend? Varian is offering their Fundamentals of Dissolution Course this month, January 21 - 22, 2004
"The Fundamentals of Dissolution Workshop is a comprehensive two-day course designed for new and emerging dissolution analysts. The course places emphasis on basic dissolution fundamentals and theory, along with focused discussions on current compendial dissolution testing apparatus, USP physical parameter requirements and the current USP calibration procedure. Also, hands-on workshops provide participants with experience preparing for and executing a dissolution test."
"This hands-on workshop includes dissolution tester familiarization, performing the dissolution test and physical suitability testing. This course will most benefit the novice dissolution analyst and those in quality control and assurance, calibration, and metrology. This course also serves as a refresher for those individuals with limited or intermediate dissolution experience. Contact Varian for more information."
Judge Says Maker of OxyContin Misled Officials to Win Patents
"Purdue Pharma, the maker of the highly profitable painkiller OxyContin, deliberately misled federal officials to win patents protecting its drug, a federal judge ruled yesterday. The ruling helps clear the way for a cheaper generic version and could lead to more lawsuits...more"
NASA Rover Captures Mars in Color
"NASA's Spirit rover yielded the sharpest picture ever taken of the surface of Mars, revealing in breathtaking detail Tuesday a completely rust-colored landscape strewn with rocks."
I just couldn't resist...What NOT to do during "Return of the King."
Stand up halfway through the movie and yell loudly, "Wait... where is Harry Potter?"
Block the entrance to the theater while screaming: "YOU SHALL NOT PASS!"
Come to the premiere dressed as Frankenfurter and wander around looking terribly confused...
Pete