Sunday, November 30, 2008

Testing Approved Drugs In The Real World With Real People

In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World."

I find the story so compelling for the following reasons . . .

  1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
  2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, November 29, 2008

Survive - 5 Ways To Get Through The Holidays

Don't miss out on the holiday season. Do your best to celebrate and enjoy it as much as possible. Here are 5 tips from Dr. Jonathan Abramowitz, in his article, "Five tips for surviving the holidays." In a nutshell, the 5 tips (in my own words) are . . .

  1. Recognize your thoughts and emotions, and slow them down
  2. Lower expectations, the holidays don't have to be perfect
  3. Take care of yourself first by modifying and changing how YOU react to people and situations
  4. Place limits on demands and ultimatums by verbally side-stepping them (e.g., replace "should," "must" and "have to" with "I wish," "maybe" and "my preference is ..."
  5. The holiday season is temporary and will be over before you know it

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, November 28, 2008

Pause And Reflect On World AIDS Day (Dec 1)


The fight is far from over. HIV continues to threaten the health of many communities in the United States. CDC data indicate that more than 1.1 million Americans live with HIV, and that an estimated 56,000 new infections occur in the United States every year. Some populations are harder hit than others. For example, it particularly affects gay and bisexual men, and affects African-Americans and Hispanics more than whites. Take a few moments to pause, reflect, and share the following resources widely.

Learn more at the:

CDC HIV/AIDS website - advice, information, fact sheets, brochures, slides, podcasts, reports, resources, and more

AIDS.gov website - Information from the Federal government about HIV/AIDS prevention, testing, treatment, research, and using new media in response to HIV/AIDS - FAQs, podcasts, RSS feeds, blogs, and more

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Thursday, November 27, 2008

Free Calorie Calculator - Find Out How Many You Burn

Whether it's the holiday season or not, find out how many calories you burn, based on your activities, and how strenous they are. "Are you a bionic calorie burner or do you slink along at a slug’s pace? Ever wanted to know how many calories you burn while talking on the phone? Or during sex? Let MSNBC provide that motivational kick you need to get your exercise routine going," says MSNBC in the introduction to its, "Burning off the fat" calorie counter."

I test drove it and was a bit surprised at how few calories I burn. I guess that's because I'm basically a couch potato. Guess I need to watch how many calories I eat.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Identify Drugs And Pills - Another free identifier resource

Online drug and pill identifiers are like cars. Each one has its own style, and drivers prefer one style over another. Here's another resource, a drug identifier offered by the Medical University of Southern Carolina (MUSC). Enjoy!

Previous Posts:
Drug Identifier - Put one on your PC
Another Free Pill Identifier - for your smart phone or PDA
Identify Those Drugs - Handy Pill Identifier


Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, November 26, 2008

Carbon Monoxide Poisoning Danger - If it burns, be cautious (video)


They call carbon monoxide the silent killer. That's because fuel burning devices can give off this poisonous gas that you can't see or smell. Learn more about this dangerous gas in this CDC video, "The Quiet Killer."

I'm posting this because we're entering the holiday season. A time when family and friends gather. It's really important to pay attention to the potential causes of carbon monoxide poisoning, and prevent a catastrophe from happening.

Additional Resources:
Protect Your Family and Yourself from Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Prevention Guidelines (available in multiple languages)

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Tuesday, November 25, 2008

Intro To The FDA GMPs - free 3 minute video

This free, short, video clip on YouTube, makes an excellent, "Introduction to Good Manufacturing Practices (GMPs)." This is a nice and easy way to expose new employees to the whole concept of the regulated pharma industry and the FDA regulations. Naturally, this clip is a trailer promotion of a training video sold by the producer. In any event, make use of this very useful, and free video clip.

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, November 24, 2008

6 Free FDA QSR Design Controls Tutorials

Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

- -  original post follows below  - -

ODDS Company describes itself as an "educational and consulting company that deals with product and process improvements at all levels (from Executive Management to engineering support staff). ODDSCO is particularly useful to medical device manufacturer organizations that always must remain auditably compliant with FDA 21 CFR 820, the Quality System Regulation."

The ODDSCO website offers 6 free tutorials for this reason, "unless basic knowledge of any claimed area of expertise is understood, the value of offered consulting and training services will not be apparent and likelihood of sales is small. But, if the free basic training is perceived as useful and indicative of consultant's knowledge, that likelihood improves. In other words, when equipped with the basic knowledge, a visitor whose organization desires to virtually automate effective QSR Design Controls compliant medical devices development with minimal resources and schedule impact could become a highly qualified customer or client."

The Six (6) Free Tutorials (go to the ODDSCO site for amplified descriptions):
1. Automating FDA QSR Design Controls Compliance
2. Integrated Product/Process Team, Concurrent Engineering, and Systems Engineering
3. The Continuous Improvement Process (CIP) and Total Quality Management (TQM)
4. Knowledge Support Systems (KSS) and Tools
5. An IPPT Supporting Decision Process
6. Project Risk Assessment

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!















SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Who Offers Live Onsite GMP Training?
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Sunday, November 23, 2008

Ever Wonder How Bleach Kills Bacteria?

Not my usual kind of post, and for some reason this caught my eye. Perhaps it's because of my microbiology and healthcare training background, and throw in my obsession with cleanliness. I've always just enjoyed and taken for granted, the marvelous cleaning power of bleach. Until now, I've never stopped to consider, "How Bleach Kills Bacteria." This Medical News Today report is fun to read as it . . .

  1. Explains how bleach attacks essential bacterial proteins in a way that's similar to the effect of high temperatures
  2. Discusses hsp33 (heat shock protein) and "molecular chaperones"
  3. Highlights the potential of this finding to give a better understanding of how our bodies might fight off bacterial infections

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, November 22, 2008

SpermCheck Vasectomy - A Home Test - Medical Device

This recent Journal of Urology abstract, "Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy, concludes that SpermCheck Vasectomy, a simple and reliable immunodiagnostic test, can provide evidence of vasectomy success or failure, and offers a useful alternative to improve compliance with post-vasectomy sperm monitoring. It is currently the only FDA-approved test for this purpose.

Monitoring is important because vasectomies are not 100 percent successful, and men who have had them can experience recanalization, or spontaneous healing, leading to restored fertility. Traditionally, after a vasectomy has been performed, the monitoring process involves bringing semen samples to a doctor's office or laboratory at two- and three-month intervals after the procedure. This at-home test is designed to help couples monitor and confirm that post-vasectomy sperm concentrations have reached infertile levels and avoid any surprises. The device is undergoing commercialization through a start-up company.

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, November 21, 2008

Verify Online Pharmacies - Save Money - PharmacyChecker.com

Online pharmacies can offer cost savings, yet they might introduce some risk if you fall prey to unethical pharmacies. Here's a resource that helps navigate through the risk, to that glory land of drug cost savings.

As detailed on their site, "PharmacyChecker.com was founded by a medical doctor in 2003 to help consumers safely save money on medication. It independently checks the credentials of online pharmacies and lets you easily compare drug prices. Its online pharmacy verification program is the largest and most accepted." They offer a report on "Safe Strategies for Drug Savings" that recommends the follow saving strategies . . .

  1. Check brand name prices at Canadian and non-U.S. online pharmacies.
  2. Check brand name prices at U.S. online and wholesale pharmacies.
  3. Check discount generic programs at large retailers and pharmacies.
  4. Check wholesale pharmacy prices on generics.
  5. Check programs based on need or fees.

Previous Posts:
No Prescription Needed - Rogue Pharmacy Sites
8 Tips - Save Money on Prescription Drugs

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Thursday, November 20, 2008

The New iPill - Intelligent pill for drug development

Healthcare IT News reports, "Philips iPill targets treatment for digestive tract diseases" This is a pretty interesting little drug delivery device, fill it up with medication, and it can be programmed to release it as it travels along.

Philips is also known for its FDA-approved "first camera pill" of 2001 used "for diagnostic applications." This new drug delivery device is intelligent pill technology named the 'iPill,' and is designed to aid drug development focusing on new therapies for gastrointestinal (GI) diseases, such as colon cancer. Here are some facts about the iPill . . .

  1. The iPill is swallowed and passes through the GI tract naturally
  2. It can be programmed to release medicine
  3. It measures the local acidity along the GI tract and can report its current location
  4. It also reports local temperatures, and does so wirelessly

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/


Wednesday, November 19, 2008

Quality by Design (QbD) For Analytical Methods (video)

Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

- - -
Updated 6/25/2015:

This post didn't age well, the links in the original post are no longer found.

You might also be interested in:   QbD Considerations for Analytical Methods - FDA Perspective

You might also be interested in the following cGMP basics training course:


=========  original post below =========

Maribel Ross, Senior Editor with Pharmaceutical Technology, discusses the FDA's quality by design (QbD) initiative as it applies to analytical methods with one of the top experts in this area, Dr. Moheb Nasr, Director of FDA's Office of New Drug Quality Assessment, in this PharmTech TV video, "Live From 2008 AAPS: Analytical Methods for QbD."

#FDA #GMP #training #cGMP

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Tuesday, November 18, 2008

FDA Scandal Brewing - Corrupted Scientific Reviews

"Top managers with the U.S. Food and Drug Administration "corrupted and interfered with'' scientific reviews of medical devices, reports this Bloomberg News article, "Democrats Probe 'Corrupted' FDA Reviews of Devices." Wow! What a powderkeg! You have to read this article, because it includes the following words and phrases, yikes!

  1. Corrupted
  2. Interfered with
  3. Reprisals
  4. Threatened
  5. Accept data that isn't scientifically valid
  6. Avoid and evade any accountability
  7. Corruption, illegality, gross mismanagement and retaliation
  8. Felt pressured to alter their work for non-scientific reasons and provide misleading information

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, November 17, 2008

Top 10 Medical Technologies To Watch For In 2009

I love these kind of lists. Trying to peer into the crystal ball is always a most interesting exercise. Here's what the Cleveland Clinic says will shape 2009, as reported in this Chicago Tribune news article, "10 medical technologies to watch in 2009." I give you the list, and you'll want to read the full article to get a better understanding of what this means to our health and our lives. And your top ten are . . .

  1. Circulating Tumor Cell Technology
  2. Warm Organ Perfusion Device
  3. Diaphragm Pacing System
  4. Multi-Spectral Imaging Systems
  5. Percutaneous Mitral Valve Regurgitation Repair
  6. New Strategies for Creating Vaccines for Avian Flu
  7. LESS and NOTES Applications: LESS (laparoendoscopic single-site surgery) takes laparoscopic surgery to a new level by reducing the process to a small cut in the belly button. NOTES (natural orifice transluminal endoscopic surgery) bypasses normal incisions
  8. Integration of Diffusion Tensor Imaging
  9. Doppler-Guided Uterine Artery Occlusion
  10. Private Sector National Health Information Exchange

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Sunday, November 16, 2008

HIV AIDS Bone Marrow Transplant Cure - Skeptical View

Don't get me wrong, I'm excited about this latest case report. However, there are alternate views of what this really means. See what I mean by reading this ABC Health Insider news article, "For AIDS, 'Cure' Is Still a Four-Letter Word." There are a couple of ways to think about this. If bone marrow transplantation really works in the long run, how do we make it widely available and affordable?! If it doesn't work, how long will it take to definitively confirm its ultimate failure?! What's your opinion?

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, November 15, 2008

Take The Weekend Off - That Means This HIV Med Too?!

Breaking news that taking a certain HIV medication, Atripla (Truvada combined with Sustiva) can be taken just during the weekday, therefore, giving a weekend off. Find out more in the Bloomberg news article, "Gilead AIDS Pill Effective in Study With Weekends Off." This is early research, so it's too early for long-term application. Here's some of the hoped for benefits . . .

  1. This fits into most people's model of a weekday versus weekend life
  2. The reduced schedule could reduce drugs costs by 29%
  3. Viral levels can be kept the same with every day or weekday only regimens

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, November 14, 2008

Web Enabled Drug Bottle Caps - They Remind You

Technology is wonderful. As a pharmacist in this space, I have to say this is exactly what we need. For example, my mother-in-law can't remember when to to take her meds, so this device would really help her. Find out more by reading this Fortune Magazine article, "Vital medicine - Disruptors: Vitality's Web-connected, glowing bottle cap reminds patients to take their pills, potentially saving millions of dollars in healthcare costs." So here's how this new-fangled thing can help . . .

  1. "Vitality" is a wireless gizmo that glows and plays a tune to remind you when it's time to take your medicine.
  2. It keeps track of your doses day by day by counting the times the cap is opened, sending the data to a Vitality-hosted database.

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Thursday, November 13, 2008

Do Not Send Money to FDA Impersonators

It's the latest scam. Someone calls you up, says they're from the FDA (as special agents), and tells you to send money for medications to the Dominican Republic. Don't do it, says this Post Chronicle news article, "FDA Issues Warning About FDA Impersonators." Reportedly, the callers have a Hispanic accent. Once you take the bait, you don't receive any medications, then they threaten to fine you if you don't send a ton of money.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra)

As you read this, remember that this is being reported by the BBC. The study mentioned, warns that up to 90% of all medicines sold on the Internet are thought to be fake, reports this BBC News article, "Men warned over counterfeit drugs - Men are being warned they could be "gambling with their lives" if they buy fake medicines online." In a nutshell . . .

  • 1 out of 10 had purchased prescription drugs without a prescription
  • It's thought that up to 90% of all medicines sold via Internet are believed to be fake
  • Men in particular, are not acknowledging the potential risks associated with ingredients contained in counterfeit drugs (e.g., talcum powder, rat poison)

Previous Posts & Other Online Resources:
Caution - Some Dietary Supplements Contain Hidden Drugs
No Prescription Needed - Rogue Pharmacy Sites
FDA: Risks of buying fake erectile dysfunction products on the Internet

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, November 12, 2008

Code of Federal Regulations (CFRs) Available Online (free) - Go Green!



This is a wonderful use of our tax dollars. Go green and stop buying hardcopies of the CFRs. On the Goverment Printing Office site, GPO Access, you can slice and dice, search, and browse published CFRs. And if you just can't help yourself, you can always print pertinent text or save portions offered as pdf files. Here's just a sampling of the different ways you can use this site . . .

  1. Listing of all CFR Titles, 1-50 (including annual publications of 21 CFR Food and Drugs since 1996)
  2. 21 CFR Food and Drugs (published April 2008) (including volumes 1-9; chapters I-III; parts 1-1499) falling under the purview of Food and Drug Administration,Department of Health and Human Services ; Drug Enforcement Administration,Department of Justice ; Office of National Drug Control Policy

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Tuesday, November 11, 2008

Caution - Some Dietary Supplements Contain Hidden Drugs

Things aren't always what they seem to be. The same goes for some dietary supplements. An estimated 150 million Americans use dietary supplements, ranging from multivitamins to herbal remedies to specialized mineral blends. So folks need to be careful about what they buy and who they buy it from, reports this Atlanta Journal Constitution article, "Dietary pills laced with drugs - After-market scrutiny: FDA warns about Blue Steel, other supplements that do not have to prove their safety." The government estimates that 30,000 to 40,000 supplement products are being sold by all sorts of companies, some large and reputable, others operating out of a garage or basement. This poses a challenge because regulators are spread too thin, and can only conduct occasional spot checks. Here are some resources that you can reference to try and protect yourself . . .

Dietary pills laced with drugs - After-market scrutiny: FDA warns about Blue Steel, other supplements that do not have to prove their safety (audio)

Resources:
FDA: Recalls & Safety Alerts for dietary supplements and other products
FDA: Risks of buying fake erectile dysfunction products on the Internet

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, November 10, 2008

HIV Treatment Goes Bionic

Bionic man. Bionic woman. Now there's bionic assassins to treat HIV. Researchers have have engineered and tested a killer T-cell receptor that is able to recognize all of the different disguises that HIV is known to have used to evade detection. The researchers attached this receptor to the killer T-cells to create genetically engineered "bionic assassins" able to destroy HIV-infected cells in culture. For the full story, read this EurekAlert, "HIV's disguises no match for 'bionic assassins' - Implications for developing new treatments for AIDS."

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Grand Opening Of Our FDA GMP Online Gift And Award Store!

We're pleased as punch to announce the opening of our online gift store, "The Health, Drug, Prescription, & GMP Online Store." While you're strolling through the aisles, consider picking up something for yourself, your colleagues, or your employees. We imagine you can find items suitable as awards, gifts, reward and recognition, and giveaways in classroom training sessions. Visit the store often, as we intend to expand the inventory over the next couple of weeks. Here's a sampling of the categories you'll find in the store . . .

  1. Bags
  2. Home & Office
  3. Mugs
  4. Cards, Prints, & Calendars

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Sunday, November 9, 2008

Pet Food Sickened People - Did they eat it? . . .

When I saw this headline for the first time, my imagination ran wild and I wondered if people got sick eating the pet food. It turns out it's more about bacterial contamination, as reported by this MSNBC news article, "Pet food sickened at least 79 people, CDC says Kibble tainted with rare salmonella may still be in homes, agency warns." In a nutshell, the contaminated pet food can make people sick if they handle the pet food, especially the very young and very old, and it causes bloody diarrhea. For this reason, the CDC is telling us to be aware that all dry pet food, pet treats, and pet supplements might be contaminated with bacteria like Salmonella, and that precautions should be taken with all brands of dry pet food, treats, and supplements.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Time To Talk About Turkey Cooking and Food Safety


Thanksgiving is here, and it's time to cook the turkey. Just be sure to follow some basic turkey cooking tips for a delicious turkey without making your family, friends, and guests sick. Here's an excellent tip sheet from the USDA, "Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey." A sampling of the tips include, fresh or frozen, stuffing, thawing, microwave, roasting, timetables, and much more . . .

Saturday, November 8, 2008

Listen To People With AIDS and HIV (audio)

This is very personal. Hear eight men and women talk about their experiences with HIV and AIDS. The New York Times has other 'Patient Voices' and this one is, "Patient Voices: AIDS and H.I.V." Hearing the stories and voices of real people make the stories jump right off the page.

Prevous Posts
The Health, Drug, Prescription, and GMP Supersite: HHS Updates HIV Treatment Guidelines (free pdf)

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Thanksgiving Alert - Cooked Turkey Can Still Cause Food Poisoning!

While cooking your turkey properly makes it safe to eat, it's really only safe to eat for a short while after being cooked and stored properly. The danger lies is what you do with it after it's been cooked, as outlined in this Medical News Today news clip, "Thanksgiving Chefs Beware: Cooking The Turkey May Not Prevent Food Poisoning." The key point is a "live" form of the bacterium, C. perfringens, is killed by cooking, but its spores survive will survive a trip through the oven. The spores aren't harmful if eaten, and they will return to their vegetative state ("live") if warm turkey meat is left too long. For a safe Thankgiving meal, follow these essential tips . . .

  1. Cook the Thanksgiving turkey to 165 degrees.
  2. Chill leftovers quickly after a meal is finished.
  3. Cut meat off the bone and store perishables in shallow pans.
  4. Reheat leftover turkey to 165 degrees and bring gravy to a boil.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, November 7, 2008

HHS Updates HIV Treatment Guidelines (free pdf)


A Department of Health and Human Services (HHS) panel has recommended two drug regimens be added to the list of preferred protease-inhibitor components in revised guidelines on the use of antiretrovirals in HIV-1-infected patients. The panel just published their revised guidelines, "
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. November 3, 2008; 1-139. These guidelines are intended to help providers make decisions about the use of antiretroviral agents.

It should be noted that these guidelines generally represent the state of knowledge regarding the use of antiretroviral agents. However, as the science rapidly evolves, the availability of new agents and new clinical data may rapidly change therapeutic options and preferences. The guidelines, therefore, are updated frequently by the Panel.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Health 2.0 Conference Recap (free podcast)

I wasn't able to get to the recent Health 2.0 Conference. If you missed it too, don't feel left out. This podcast provides some quick highlights on the latest Health 2.0 applications and consumer trends from the Health 2.0 Conference in San Francisco. In this Manhattan Research eHealth Trends podcast episode, Meredith Abreu Ressi tells us what we need to know, "Health 2.0 Conference Recap - Episode 23."

Related Stories:
Over 60 Million US Adults Use Health Blogs, Online Support Groups, Prescription Rating Sites, And Other Health-related Social Media Applications
Health 2.0 Conference Recap - Episode 23 (transcript)

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Thursday, November 6, 2008

Strong, New FDA Leader Needed

Under Obama's watch, a new, strong FDA leader is needed. Many are calling for this, as evidenced by this Reuters news article, "Industry, critics seek strong FDA leader." It's important to fill this FDA post as soon as possible, but it seems that the reality is that it will take some time to do so.

In the meantime, let's hope that the FDA can limp along as best it can.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Caregivers - Medicare and Care Resource Website



Sometimes it's hard to take care of someone with healthcare needs. As a caregiver, you need access to information and resources. This Medicare website is chockful of great information and resources, Medicare - Caregiver Information. Here's what's on the site . . .

  1. Help with billing
  2. Navigating Medicare
  3. Overwhelmed? Get help
  4. Care options
  5. Medicare basics
  6. ... and more!

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, November 5, 2008

The FDA History - Teaching Resources (free)

Updated August 8, 2016

Many of the links below have broken over time.  However . . .

The FDA still maintains many of these related areas of interest.
Just start here:  FDA History - Main Webpage

This live onsite course teaches the FDA cGMP basics, "Essentials for Pharmaceutical Manufacturers."

Designed for new employees and refresher GMP training for your seasoned staff.
cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

- -  the original post follows below  - -

If you're responsible for teaching or delivering training on the FDA's history, then run, don't walk to this terrific site of FDA history resources, "FDA History." At this site, you get the chronological account of events leading up to the current state of affairs. Here's what you'll be able to reference . . .

History of the FDA
A brief history of FDA from its origins to the present.
Milestones in FDA History
Food and drug law milestones from 1820 to the present.
The Long Struggle for the 1906 Law
Story of the passage of the Food and Drugs Act of 1906.
Activists in the 1906 Pure Food and Drug Act Legislative Campaign
An evolving document listing 1906 activists and their successor organizations
A Brief History of Drug Regulation
Description of the evolution of the drug regulatory function at FDA from 1902 to the present, including an Index and a Timeline.
Annual NDA Data, 1938 to the Present
A year-by-year tabulation of the total number of New Drug Applications received and approved, including all New Molecular Entities.
Regulating Biological Medicines
A commemoration of the Biologics Control Act and the history of how vaccines, blood, and other biological products were regulated.
Regulating Veterinary Medicine
A historical look at the regulation of products for animals.
The Laws Behind the Labels
Describes the change from a food and drug law that was primarily a criminal statute to a law that is now dominantly preventive through informative regulations and premarket controls.
Slideshow: The Rise and Fall of Federal Food Standards in the United States: The Case of the Peanut Butter and Jelly Sandwich
Scrutiny of the ingredients in the peanut butter and jelly sandwich illustrates the importance of food standards to insure value to consumers.
FDA's 2006 Centennial Celebration

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Who Offers Live Onsite GMP Training?
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Tuesday, November 4, 2008

WHO Basic GMP Training Modules (free)

WHO Basic GMP Training Modules (free)


Updated 9/24/2015:
WHO revamped their sites. You might be interested in:
WHO Good Manufacturing Practice (GMP) training modules

You might also be interested in the following cGMP basics training course:


If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!












===

Updated 11/18/2011 - I discovered the links went bad. Hopefully, these updated links work better.

If you're a GMP trainer on a budget, consider leveraging some of these free powerpoint slides made available from the World Health Organization (WHO) and posted on this site, "WHO Basic Training Modules on GMP." This site provides some background for trainers, introduces the available modules, and how best to use them for training purposes. Here's a quick peek at the index of slide decks offered . . .


 Basic Principles of GMP: Module 1     
 GMP Inspection Process: Module 2

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: Free WHO Training Guide To GMP Requirements

You might also be interested in:

Essentials for Pharmaceutical Manufacturers - a training class by SkillsPlus International Inc.
This class teaches employees the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.
#FDA #GMP #training #cGMP

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Monday, November 3, 2008

FDA Struggles To Keep Products From Foreign Sources Safe

This is required reading for consumers, and for professionals working in the GXP regulated industries (obtaining supplies, food, drugs, etc. from foreign suppliers). Gardiner Harris, a correspondent in The New York Times’s Washington bureau, writes about the very dangers and risk that are lurking out there in this NY Times news article, "The Safety Gap." The article is extremely well written and is full of anecdotes, statistics, and critical analysis that will make you think twice about the food and drugs that all of us are personally using. Here's what made me cringe . . .

  1. It worries me that contributors to the story wanted to remain anonymous. It seems to me that perhaps the problem is much bigger than folks are willing to admit.
  2. I'm guessing that the contaminated heparin from China incident is probably just the tip of a massive iceberg.
  3. No surprise, the FDA is underfunded, understaffed, and ill-equipped to deal with the pent-up demand for foreign plant inspections.
  4. It appears there is a danger that foreign plants are less committed to quality standards, and in some cases demonstrate a lack of ethical behavior.
  5. I could go on, but it's much better for you to read the news article.
Let the buyers beware (that means us as consumers, and companies partnering with foreign plants).

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Sunday, November 2, 2008

How The FDA Regulates Botanical Drugs

You have to read this. In an issue of Nature Biotechnology, you'll learn how FDA personnel review applications to test botanical drugs in humans, and market those products in the US as reported in this article, "New therapies from old medicines - Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met (pdf)." In general, here's what it's all about . . .

  1. From dietary supplements to new drugs
  2. Current US regulatory environment
  3. Review of botanical applications at CDER
  4. Analysis of botanical drug IND submissions
  5. Unique regulatory issues
  6. Botanicals as variable, complex mixtures
  7. Botanicals as multiple-plant combinations
  8. Previous human use of botanicals
  9. Botanicals marketed as dietary supplements

It's encouraging to me to see these kinds of articles appearing on the topic. Personally, I'd consider using more botanicals if I can see that some form of rigor is applied to them.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Apple Cider Caution In The Autumn

I love the fall, and I've enjoyed having fresh apple cider. I'm sure many of you do to. Here's some things you should know about to avoid getting sick or making others sick from unpasteurized apple cider. Find more recommendations in this Medical News Today news article, "As Autumn Arrives Beware Of Unpasteurized Cider And Juices, Warns Iowa Department Of Public Health." Here are some, but not all, of the main points that I take away . . .

  1. Unpasteurized cider can be a health risk, especially to children and those who have weakened immune systems
  2. Cider should be kept refrigerated at 40 F or cooler
  3. Risk of illness can be reduced by heating unpasteurized apple cider to at least 170 F before drinking

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, November 1, 2008

Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It

Election time is near, sometimes the candidates have the same view, and sometimes they differ. They happen to agree and reaffirmed their support for allowing Americans to import cheaper prescription drugs from abroad, but both campaigns note that concerns over international drug safety will take precedence in determining this policy, commonly known as drug reimportation. Read this Henry Kaiser Foundation post for more details, "Election 2008 - Both Major Presidential Candidates Support Prescription Drug Reimportation, Cite Need To Ensure Safety." In a nutshell, here are the high points . . .

  1. Recent incidents like the tainted heparin from China, highlight the need to ensure drug safety abroad.
  2. There's a need to focus on global areas with strong track records of safety.
  3. We need to make sure that all imported drugs meet state and federal standards for safety.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Turn Your Clocks Back - Reduces Heart Attack Risk - Sweet!

It turns out that turning your clocks ahead in the Spring increases your risk of heart attack, and turning your clocks back (like this weekend) in the Fall reduces the risk of heart attack. I wanted to share the source New England Journal of Medicine article with you, but the best I could do was share this Medical News Today summary article for you, "Heart Attack Risk Raised When Clocks Go Forward, And Are Reduced Slightly When Clocks Go Back."

Wishing you some extra health from turning your clocks back this weekend.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
    GMP Training Gifts & Giveaways