Follow us on




Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

 Forums
Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by  on 2010-01-27 19:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by  on 2010-01-22 18:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by  on 2010-01-21 19:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by  on 2010-01-14 04:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by  on 2010-01-12 20:15:13
PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Cancer   by  on 2010-01-11 04:23:31
PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS   by  on 2010-01-11 04:00:18
EMEA Guidelines on Cystic Fibrosis Drug Development   by  on 2010-01-05 17:14:16
US-FDA' proposed rule on Informed Consent regulations   by  on 2010-01-03 06:22:47
US FDA Warning Letters in Clinical Investigation for the Month of December 2009   by  on 2009-12-31 17:10:00
International Compilation of Human Research Protections 2010 Edition   by  on 2009-12-23 22:59:39
ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials   by  on 2009-12-18 04:11:05
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by  on 2009-12-18 03:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by  on 2009-12-05 02:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by  on 2009-11-30 18:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by  on 2009-11-21 15:57:50
Companies to Disclose All Clinical Trials in Patients   by  on 2009-11-19 17:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by  on 2009-11-09 17:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by  on 2009-11-09 06:28:30
PhRMA's New Clinical Trial Guidelines   by  on 2009-10-05 18:21:30
 Subject :PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV.. 2010-01-11 04:00:18 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Clinical Operations
Topic : PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS

Subject :PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS

Dear Friends,

America’s pharmaceutical research and biotechnology companies are testing 97 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

The report found that of the 97 products in development, 23 are vaccines and 54 are antivirals. These drugs are either in human clinical trials or awaiting approval by the U.S. Food and Drug Administration.

Kind regards,
IP Logged
GCP HelpDesk
 Subject :Catch-up Immunization Schedule for Persons Aged 4 months - 18 Years—.. 2010-01-05 19:05:39 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Catch-up Immunization Schedule for Persons Aged 4 months - 18 Years—USA, 2010

Subject :Catch-up Immunization Schedule for Persons Aged 4 months - 18 Years—USA, 2010

Dear Firends,

This table provides catch-up schedules and minimum intervals between doses for children whose vaccinations have been delayed.

Best regards, 


IP Logged
 Subject :Immunization Schedule for Persons Aged 7 - 18 Years—USA, 2010.. 2010-01-05 19:03:15 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Immunization Schedule for Persons Aged 7 - 18 Years—USA, 2010

Dear Firends,

This schedule includes recommendations in effect as of December 15, 2009.

Best regards,


Attachments
 7through18.pdf [100 KB] ::
IP Logged
 Subject :Immunization Schedule for Persons Aged 0 - 6 Years—USA, 2010.. 2010-01-05 19:00:46 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Immunization Schedule for Persons Aged 0 - 6 Years—USA, 2010

Dear Firends,

This schedule includes recommendations in effect as of December 15, 2009.

Kind regards,


Attachments
 0through6.pdf [139 KB] ::
IP Logged
 Subject :Recommended Childhood and Adolescent Immunization Schedules—USA, 201.. 2010-01-05 18:56:18 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Recommended Childhood and Adolescent Immunization Schedules—USA, 2010

Subject :Recommended Childhood and Adolescent Immunization Schedules—USA, 2010

Dear Friends,

The 2010 recommended childhood and adolescent immunization schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians.

Please find attachment here.

Best regards,


Attachments
 Immunization.pdf [217 KB] ::
IP Logged
Last Edited On: 2010-01-05 18:56:18 By Sathvika for the Reason
 Subject :The Medicines Company Files Additional Patent Infringement Lawsuits.. 2010-01-05 17:28:21 
Sree
Newbie
Joined: 2009-09-18 20:04:52
Posts: 16
Location
Forum : Patent News
Topic : The Medicines Company Files Additional Patent Infringement Lawsuits

The Medicines Company (NASDAQ: MDCO) today announced that it has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and related entities in the United States District Court for the District of Delaware alleging patent infringement based on Abbreviated New Drug Applications seeking U.S. Food and Drug Administration approval to market and sell generic versions of The Medicines Company's Angiomax® product prior to expiration of U.S. Patent No. 7,598,343 ("the '343 patent").

Each lawsuit alleges infringement of the '343 patent which was issued on October 6, 2009. As previously announced, The Medicines Company has patent infringement lawsuits pending against the same parties in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 7,502,727.
IP Logged
 Subject :EMEA Guidelines on Cystic Fibrosis Drug Development.. 2010-01-05 17:14:16 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : EMEA Guidelines on Cystic Fibrosis Drug Development

Dear Friends,

The European Medicines Agency (EMEA) first guideline on developing products to treat cystic fibrosis advises drug makers to use forced expiratory volume (FEV) as the primary lung-function endpoint when designing clinical trials for the drugs. A clinically relevant change in FEV should be defined and justified by drug makers, as should the frequency of FEV measurements, according to the final guideline posted on the EMEA’s website last month.

Click here for this guideline

Kind regards,

IP Logged
GCP HelpDesk
 Subject :US-FDA' proposed rule on Informed Consent regulations.. 2010-01-03 06:22:47 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : US-FDA' proposed rule on Informed Consent regulations

Dear Friends,
 
The FDA is issuing a Proposed Rule, that if finalized, would amend the Informed Consent regulations. (Federal Register 12/29/2009) To read more click here.
 
Thanks and regards,
IP Logged
GCP HelpDesk
 Subject :US FDA Warning Letters in Clinical Investigation for the Month of Dece.. 2009-12-31 17:10:00 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Regulatory/FDA Warning and Notice of Violation Letters to Pharmaceutical Companies
Topic : US FDA Warning Letters in Clinical Investigation for the Month of December 2009

Subject :US FDA Warning Letters in Clinical Investigation for the Month of December 2009

Dear Friends,

Please find attached US FDA warning letter for the month of December 2009.

Thanks and regards,


Attachments
 December 2009.pdf [25 KB] ::
IP Logged
GCP HelpDesk
 Subject :Novel Potassium- Competitive Acid Blocker (P-CAB) Soraprazan for GERD.. 2009-12-26 18:00:55 
Harrison
Newbie
Joined: 2009-07-13 23:53:04
Posts: 31
Location
  • 4294967292
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Novel Potassium- Competitive Acid Blocker (P-CAB) Soraprazan for GERD

Dear friends,
 
After treatment of millions of patients suffering from Gastroesophageal Reflux Disease (GERD) and other acid-related ailments with proton pump inhibitors, there are still unmet medical needs such as rapid and reliable pain relief, especially for nocturnal acid breakthrough. Here is the biochemistry and pharmacology of the potassium- competitive acid blocker (P-CAB) Soraprazan, a novel, reversible, and fast-acting inhibitor of gastric H,K-ATPase.Soraprazan shows immediate inhibition of acid secretion in various in vitro models and in vivo and was found to be more than 2000-fold selective for H,K-ATPase over Na,Kand Ca-ATPases.
 
Soraprazan is superior to esomeprazole in terms of onset of action and the extent and duration of pH elevation in vivo in the dog. Rapid and consistent inhibition of acid secretion by Soraprazan renders the P-CABs a promising group of compounds for therapy of GERD.
 
Thanks and regards,

Attachments
 soraprazan.pdf [734 KB] ::
IP Logged
Last Edited On: 2009-12-26 18:00:55 By Harrison for the Reason
 Subject :International Compilation of Human Research Protections 2010 Edition.. 2009-12-23 22:59:39 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : International Compilation of Human Research Protections 2010 Edition

Dear Friends.

The 2010 version lists about 1,100 laws, regulations, and guidelines on human subject protections from 96 countries. This year’s Compilation includes listings from 5 new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar.


Many of the listings include the web address, allowing the reader to link directly to the law, regulation, or guideline of interest.


Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world.

You can reach the version by clicking here or from this link: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

Kind regards,

IP Logged
GCP HelpDesk
 Subject :Vegetable intake during Pregnancy & Islet Autoimmunity in Offsprin.. 2009-12-23 22:05:19 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Vegetable intake during Pregnancy & Islet Autoimmunity in Offspring

Dear Friends, 

Please find attached a commentary on the relation between vegetable intake and islet cell autoimmunity,

Thanks,


IP Logged
 Subject :Review article on Prehypertension.. 2009-12-23 21:59:53 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Review article on Prehypertension

Dear Friends, 
 
Please find attached a review article on the epidemiology, consequences and treatment of prehypertension.
 
Thanks,

IP Logged
 Subject :Proposed treatment algorithm for the use of Dronedarone.. 2009-12-23 21:51:09 
Sree
Newbie
Joined: 2009-09-18 20:04:52
Posts: 16
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Proposed treatment algorithm for the use of Dronedarone

Hi,

Please find attached article on proposed treatment algorithm for the use of Dronedarone in the therapy of patients with atrial fibrillation.

Thanks,


Attachments
 dronedarone.pdf [94 KB] ::
IP Logged
 Subject :NPC1L1 Inhibitors.. 2009-12-21 23:33:20 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : NPC1L1 Inhibitors

Please find attached an article which describes the mechanism of action of ezetimibe (NPC1L1 inhibition). The back translation of the target from the drug has led to improvements in drug discovery (Forward translation) and a new group of agents are in pipeline.

IP Logged
Last Edited On: 2009-12-21 23:33:20 By Sathvika for the Reason
 Subject :ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical .. 2009-12-18 04:11:05 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Clinical Operations
Topic : ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials

Subject :ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials

Dear All,

Imaging with cardiac ultrasound is a critical element of cardiovascular clinical research. The noninvasive assessment of cardiac structure, function, and hemodynamics using echocardiography can provide essential data on the safety and efficacy of drugs and devices, as well as insight into mechanisms of disease and therapeutic benefit. Echocardiography may also be used to assess enrollment eligibility, provide surrogate endpoints, suggest future research directions, and assist in determining optimal patterns of clinical surveillance. However, the value of this information is highly dependent on the quality of the planning and performance of imaging, the quality of data analysis, and the appropriate incorporation of results into overall trial analysis.  A previous ASE document, "Recommendations for Use of Echocardiography in Clinical Trials," describes the importance of high-quality imaging for research. It recommends methods for some of the common applications of echocardiography, such as determinations of left ventricular ejection fraction and mass, but it does not extensively address the roles and responsibilities of core laboratories or other issues such as personnel, study design, imaging review charters, site management, information technology, and statistical analysis. No other document or guidelines statement exists to fill these gaps. Thus, there is a great need for a clear and universally accepted set of "best practices" in these areas, which form the core of this consensus-driven standards document. 

Click here for this ASE Expert Consensus Statement on Echocardiographic Imaging in Clinical Trials: American Society of Echocardiography Standards for Echocardiography Core Laboratories: Endorsed by the American College of Cardiology Foundation.

Kind regards,

IP Logged
GCP HelpDesk
 Subject :USFDA's Final Guidance for Industry Patient-Reported Outcome Measures.. 2009-12-23 22:12:04 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : USFDA's Final Guidance for Industry Patient-Reported Outcome Measures

Dear All,

After three years of comment review, the FDA has issued a final guidance on patient-reported outcome (PRO) instruments submitted in applications. Sponsors should define the role a PRO endpoint plays in trials so appropriate statistical methods can be planned and applied, the guidance says. The guidance revises a February 2006 draft, for which the agency received 22 comments.

Click Here for this document.

Kind regards,

IP Logged
Last Edited On: 2009-12-23 22:12:04 By GCP HelpDesk for the Reason
GCP HelpDesk
 Subject :Historical Events in Clinical Research: Part III.. 2009-12-17 22:31:54 
Harrison
Newbie
Joined: 2009-07-13 23:53:04
Posts: 31
Location
  • 4294967292
Forum : Clinical Research Milestones
Topic : Historical Events in Clinical Research: Part III

1832: Physician William Beaumont signs a contract with Alexis St. Martin, a long-term research subject with a permanent gastric fistula (hole to his stomach), whereby Mr. Martin enlists in the Army for one-year – with no military duties – and receives payment of $150.

1833: Physician William Beaumont publishes research ethical guidelines, including voluntary consent and right to withdraw.

1836:
Army Surgeon General establishes library, later to become the National Library of Medicine, the world’s largest.

1836: French physician Pierre-Charles-Alexandre Louis conducts a quantitative epidemiologic study of the treatment of pneumonia with bloodletting. (Bloodletting may relieve pulmonary edema – excess fluid in the lungs.) He finds that the duration of the disease is shorter in patients who are bled sooner rather than later, with the caveat that mortality is 76% higher.

1845: Max Simon writes that experimentation is necessary to advance science, but under no circumstances could a physician “sacrifice the interests of the individual to those of society” or to “scientific speculation.”

1847: American Medical Association adopts a code of ethics, including the “sacred duty” to avoid disclosures that would discourage or depress the patient.

1848:
Drug Importation Act requires U.S. Customs Service to inspect all medications entering U.S. ports for quality, purity, and fitness for medical purposes.

1849: In “Physician and Patient,” Worthington Hooker discusses the doctor-patient relationship, writing that “the good, which may be done by deception in a few cases, is almost as nothing, compared with the evil which it does in many cases.”

1851: American Pharmaceutical Association founded, later renamed the American Pharmacists Association.

1852: Physician Marion Sims, the “father of gynecology,” reports in the Journal of the American Medical Sciences that on his thirtieth attempt with slave women – probably without their informed consent and perhaps without their consent at all – he successfully repaired a vesicovaginal fistula (without anesthesia).

1862: President Abraham Lincoln appoints Charles M. Wetherill, a chemist, to the Department of Agriculture, the first step towards formation of the Bureau of Chemistry, predecessor of the Food and Drug Administration.

1865: In “An Introduction to the Study of Human Experimentation,"" French physiologist Claude Bernard states "Never perform an experiment that might be harmful to the patient even though highly advantageous to science or the health of others.”

1866: American Society for the Prevention of Cruelty to Animals is founded.

1868: Pharmacy Act requires testing and registration of persons who dispense drugs such as morphine, cocaine, and barbiturates, but not patent medicines that may contain those drugs.

1871: Court rules in Carpenter v. Blake that the physician must fully inform the patient before departing from standard medical practice.

1875: UK Sale of Food and Drugs Act prohibits sale of drugs not of the proper nature, substance and quality.

1876: Britain passes Cruelty to Animals Act and Animals (Scientific Procedures) Act, protecting animals used in research.

1877: American Humane Association is founded to protect animals and, later, children.

1879: S. Potter and Eugene F. Storke conduct double-blind experiment at the Milwaukee Academy of Medicine, comparing a homeopathic remedy to a sugar pill.

1880: German physician Gerhard Armauer Hansen, co-discoverer of the leprosy bacillus, loses his license to practice medicine after deliberately infecting the eye of a patient with leprosy bacilli.
IP Logged
 Subject :New Guidelines on Reporting Industry-Supported Clinical Trial Results:.. 2009-12-05 03:14:15 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP

Subject :New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP

Dear All,
 
Here is the new GPP2 Guidelines on reporting Industry-Supported Clinical Trial Results.

Click here to download the GPP2 Guidelines.

The landmark guidelines on Good Publication Practice (GPP) published in 2003 were developed with the aim of ensuring that “clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner.”

To address legislative, guidance, and ethical developments since 2003, and to reinforce the aims of the original document, the International Society for Medical Publication Professionals (ISMPP) convened a Steering Committee to develop a revised Good Publication Practice document to be known as “GPP2”. The committee’s work, GPP2, was independently peer reviewed and published in BMJ (2009;339:b4330).

GPP2 provides comprehensive guidance on a number of key issues, including:

• Roles of authors, sponsors, and other contributors
• Reimbursement and honoraria
• How to establish a publication steering committee
• Role of professional medical writers
• Recommendations for publication planning and documentation
 
Kind regards
IP Logged
Last Edited On: 2009-12-05 03:14:15 By GCP HelpDesk for the Reason
GCP HelpDesk
 Subject :Ethical Guidelines for Intervention Studies in New Zealand.. 2009-11-30 18:28:34 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Ethical Guidelines for Intervention Studies in New Zealand

NEAC has developed guidelines on conducting intervention studies that aim to contribute to better health outcomes for New Zealanders by further developing best practice in intervention studies.

In an intervention study, an investigator intervenes to prevent, diagnose or treat illness or disease, and also studies the effects of the intervention for its safety and/or benefit. A clinical trial of a new blood pressure medicine is an example of an intervention study.

The evidence that intervention studies provide is a fundamental driver of innovation, patient safety and improved care so healthcare organizations should welcome the conduct of well-designed intervention studies. Intervention studies also have the potential both to benefit and to harm participants, so it is important that they are scientifically and ethically sound.

These Guidelines aim to help investigators to think through and address the ethical issues in their studies. They bring together in one document, and build on, the best current national and international guidance on intervention studies. The Guidelines also aim to assist ethics committees, study sponsors, organisations that host research and others with an interest in intervention studies. They also address New Zealand-specific issues (eg, compensation for injury).

Document availability

Ethical Guidelines for Intervention Studies
If you would like a hard copy of this publication please email neac@moh.govt.nz

IP Logged
GCP HelpDesk
Page #  «StartPrev12345678910NextEnd»


Powered by ccBoard