Navigation Links
Genesis of SUPAC

Scale-UP and Post Approval Changes (SUPAC) is an integral part of pharmaceutical product development but till a few years ago, no guidance was available, to assure a smooth scale-up operation. US FDA was the first regulatory body to address this issue. //

Any pharmaceutical product developed by R&D team has to undergo various stages of scale-up from ‘laboratory-scale’ to ‘pilot-scale’ to ‘production-scale’ before it reaches the market. Scale-up process is an inherent part of overall product development activity and by virtue of variables involved poses a challenge to the product stability and performance. This makes scale-up a very critical component, which if not handled sensitively can undo all the R&D efforts.

Russo, in 1984 discussed the factors influencing the scale up process of various dosage forms. Factors such as variability of raw material, equipment differences, wet granulation effects, and compression press differences have been analysed for their role in scale-up process. The difficulties observed during scale-up of liquid formulations (sterilisation process) and for suppositories, which are quite dependent upon suppository making machines were also enumerated.

Pondell, in 1985 analysed the process variables involved in the film coating operation. Importance of factors like variation in supply of raw material and their response to processing and variation in instrumentation type. Problems crop up during scale up because at R&D scale the product is developed using fairly standard equipment and under controlled conditions compared to production level. The ultimate success of a product, to a great extent is determined by how easily and cost-effectively it can be commercialised.

'"/>




Page: 1

Related medicine news :

1. Acupuncture May Help Chemotherapy Side Effects
2. Antioxidants protect health tissue in people undergoing radiation therapy.
3. Distraction therapy found very effective in postoperative patients
4. Acupuncture superseeds massage therapy for short term relief of pain
5. Ovarian cancer in relationship with Hormone therapy
6. New therapy better at increasing bone density
7. Gene therapy - Aim to improve blood flow
8. Heat therapy relieves back pain
9. Radiotherapy helps in colon cancer
10. New therapy for pimples
11. Support therapy helps breast cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Genesis SUPAC

(Date:3/27/2015)... Canadian Cannabis Clinics ( http://www.cannabisclinics.ca ), ... of medical cannabis as a treatment for patients ... clinics dedicated to providing access to safe medical ... patients searching for medical marijuana treatment in legal ... sub domain for Canada. , With the ...
(Date:3/27/2015)... The Florida Center for Brain Tumor ... (ABC2), awarded $350,000 to support brain cancer research at ... Research Institute and H. Lee Moffitt Cancer Center and ... clear development path and potential to provide meaningful improvements ... , The awards fund research in areas on ...
(Date:3/26/2015)... Let’s not lose focus of why ... today’s traffic magnets. Three out of 4 consumers choose ... produce department, according to a Packaged Facts survey. Produce ... looking to add more fruits and vegetables to their ... is April 2. As featured in the Chase’s Calendar ...
(Date:3/26/2015)... The American College of Traditional Chinese Medicine announces several ... DAOM Program as well as Marketing Basics for Healers & ... by Dr. Carla Wilson, who will give an overview of ... prepare for the spring quarter. The webinar will be from ... and April 3. Attendees can log in from work or ...
(Date:3/26/2015)... Building off their success and ... the Cardiometabolic Risk Summit and ... are proud to announce a pioneering professional ... interdisciplinary program , which ultimately grants a Certified ... physicians, nurse practitioners, physician assistants, registered dietitians, and ...
Breaking Medicine News(10 mins):Health News:Canadian Cannabis Clinics (CCC) to Join the Canada.MarijuanaDoctors.com Network 2Health News:The Florida Center for Brain Tumor Research and Accelerate Brain Cancer Cure Award $350,000 to Florida-Based Researchers 2Health News:The Florida Center for Brain Tumor Research and Accelerate Brain Cancer Cure Award $350,000 to Florida-Based Researchers 3Health News:ACTCM Announces Upcoming Webinars 2Health News:Certified Culinary Medicine Specialist Program Jointly Launched by Goldring Center for Culinary Medicine at Tulane University and Cardiometabolic Risk Summit 2Health News:Certified Culinary Medicine Specialist Program Jointly Launched by Goldring Center for Culinary Medicine at Tulane University and Cardiometabolic Risk Summit 3
... A study finds that sleep deprivation can adversely affect ... the expectation of gains and making light of ... understand the neural underpinnings of risky decision making under ... Duke University studied healthy volunteers as they underwent functional ...
... older women - those 80 or older - have the greatest ... today. ,Worryingly, the research also found that 56 per ... cancer risk. ,The strongest risk factor for breast cancer ... her risk. About one in 70 women will develop breast cancer ...
... risk of cancer; a Danish study conducted amongst 28,000 ... ,Danish medical records were analyzed to monitor ... among the utility workers for 23years. This was done ... and its effects. ,The researchers did not ...
... definite link between pregnancy, migraine and stroke, US researchers ... one. ,In fact, Cheryl Bushnell, assistant professor ... Disease in Durham, explained that pregnant women who suffered ... than pregnant women who did not suffer migraine. ...
... talked about testosterone cream for enhancing sexual desire in female ... conducted by Mayo clinic has shown. ... As an extension to a previous study which pointed a ... with sufficient estrogen levels, this new study was conducted on ...
... one out of depression. But its potential to drive ... ,Now the U.S. Food and Drug Administration (FDA) ... the existing black box warning on their products' labeling ... and behavior, in young adults ages 18 to 24 ...
Cached Medicine News:Health News:Sleep Deprivation can Affect Competent Decision-making 2Health News:Women Unaware of When Breast Cancer Risk is Greatest 2Health News:FDA Advisory Against Anti-depressants to Be Expanded to Cover Young Adults too 2Health News:FDA Advisory Against Anti-depressants to Be Expanded to Cover Young Adults too 3
(Date:3/27/2015)... March 27, 2015 RnRMarketResearch.com ... therapeutic market research report of 52 pages with ... business intelligence library. The report "Visceral ... the therapeutic development for Visceral Pain, complete with ... drug target, mechanism of action (MoA), route of ...
(Date:3/27/2015)... YORK , March 27, 2015 /PRNewswire/ ... the leading source of health information, today ... the new National Action Plan for ... President Obama emphasized the urgency and importance ... on national and global health.    ...
(Date:3/26/2015)... PASADENA, Calif. , March 26, 2015 ... San Gabriel Valley to perform transcatheter aortic valve replacement ... TAVR procedure is a revolutionary new way to replace ... use of a heart lung machine. The ... heart team led by Azhil ( Alex) Durairaj , ...
Breaking Medicine Technology:Visceral Pain Pipeline Review H1 2015 Market Research Report 2Visceral Pain Pipeline Review H1 2015 Market Research Report 3Visceral Pain Pipeline Review H1 2015 Market Research Report 4Exclusive: WebMD Interviews President Obama About Plan for Combating Antibiotic Resistance 2Exclusive: WebMD Interviews President Obama About Plan for Combating Antibiotic Resistance 3Huntington Memorial Hospital Performs Groundbreaking Minimally Invasive Replacement of Heart Valves 2
... is a premium agarose used for isolating ... agarose produces clear sharp bands, with no ... of UltraClean Forensic Agarose is tested and ... RNase activity and DNA contamination. ...
... is specifically formulated for high resolution of ... bp. This standard melting temperature agarose can ... 10 bp difference in size. UltraPure™ ... structure for better handling and improved clarity ...
Excellent multi purpose agarose Nuclease-free, Gel point (1.5%): 36 1.5 C, EEO: 0.05-0.13 Gel strength (1%): > 1200 g/cm 2 ....
... solid. Highly purified non-ionic fraction of agar. ... very low concentrations. Can be mounted on ... films are elastic and durable and show ... either protein or lipoprotein dyes. Contaminants: ...
Medicine Products: