Monday, 30 November 2015

Super veggies: Potatoes, onions keep stomach cancer at bay

Vitamin C in white vegetables like potato acts as an antioxidant to cut down cellular stress in the stomach and it also fights a bacterium responsible for causing gastric cancer. 
Scientists have discovered that eating potatoes and cabbage can help reduce the risk of developing stomach cancer.
It found that people who eat a large amount of white vegetables, such as onions and cauliflower, were a third less likely to develop it than those who did not eat them.
But the risk was increased through beers, spirits, salt and preserved food.
The study was conducted by scientists at Zhejiang University in China.
It used 76 existing studies into diet and stomach cancer which have involved 6.3m people being surveyed and 33,000 deaths from the disease.
It found that for every 100g of fruit someone eats daily the risk of developing stomach cancer is reduced by fiver per cent, the risk was reduced to eight per cent for every 50mg of vitamin C - the equivalent of two potatoes.
Whereas salt increased the risk by 12 per cent.
Former nurse weaves princess wigs for children undergoing chemotherapy Stomach cancer kills around 13 people every day in Britain and has just a 15 per cent 10 year survival rate. 

Cabbage, kale and celery were also found to be preventives against the disease. 

All of the vegetables are thought to contain vitamin C, commonly found in potatoes, which acts as an antioxidant against cellular stress in the stomach. Eating around 50g of the vitamin every day brought the risk of developing the disease down by eight per cent. 

Scientists estimated for every 100g of fruit eaten daily the risk of cancer decreased by an average of five per cent. 

Vitamin C is thought to be the key nutrient, which acts as an antioxidant to cut down cellular stress in the stomach as well as fighting a bacterium responsible for causing gastric cancer. The scientists analysed 76 best studies on diet and stomach cancer, which involved more than 6.3 million people and almost 33,000 deaths from the disease, The Times reported.

"Both fruit and white vegetables are rich sources of vitamin C, which showed significant protective effect against gastric cancer by our analysis."

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Researchers develop new sensor that can detect estrogen levels in body fluids

Researchers develop new sensor that can detect estrogen levels in body fluids
A schematic shows the new sensor that can detect low levels of E2, one of the primary estrogen hormones, in liquids.Image Credit: Victoria University of Wellington
Researchers have developed a new sensor that could detect levels of estrogen in body fluids like saliva or test for hormone contamination in waterways.
Estrogen is one of the main hormones that regulates the female reproductive system - it can be monitored to track human fertility and is sometimes administered to livestock to control the reproductive cycle. Researchers from the Victoria University of Wellington in New Zealand developed the sensor that can detect low levels of E2, one of the primary estrogen hormones, in liquids.
The sensor sends an electronic signal in the presence of estrogen and, with further development, could test estrogen levels in body fluids or test waterways for estrogen contamination that might pose a risk to humans and the environment.
The sensor has a simple design, gives real-time readings, could be integrated into an electronic monitoring system and uses very little power - advantages it has over other types of detection methods. The device uses small snippets of DNA called aptamers to latch onto estrogen molecules.
"Aptamers are a potentially powerful tool for sensors because they are so versatile and selective," said Natalie Plank, a researcher at the Victoria University.  Aptamers are developed through a process similar to natural selection. From a diverse starting population of different DNA or RNA nucleotide sequences, the ones that bind best to the target molecule are selectively enriched, and the process is repeated over multiple "generations."
Once the appropriate sequence of nucleotides is known, the aptamers can be easily generated. The researchers attached their estrogen-binding aptamers to the carbon nanotube thin film field effect transistor (CNT FET). CNT FETs work like traditional transistors, but use carbon nanotubes instead of silicon. They then tested two different estrogen-binding aptamers - one that was 35 units long and another that was 75 units long.
The researchers found that in the presence of estrogen the short aptamer device produced an electrical signal, while the long aptamer device did not. When the buffer is placed on top of the CNT FET, the voltage across the device causes the molecules in the buffer to arrange into an electrically stable bilayer above the transistor.
Estrogen molecules that are caught by the short aptamer disrupt this layer, which in turn changes the current through the device. Estrogen molecules caught by the longer aptamer are likely held above the bilayer, and so do not create the electrical signal.
The study was published in Journal of Vacuum Science and Technology B.

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Government launches injectable vaccine to prevent polio re-emergence

Union health minister JP Nadda with MoS for Ayush Shripad Yesso Naik launched the Inactivated Polio Vaccine (IPV) in New Delhi on Monday. (PTI)

In the wake of re-emerging polio, the government launched an injectable vaccine on Monday to be administered in addition to polio drops to double the protection from the deadly virus which has chances of coming back.
The inactivated polio vaccine (IPV) will be introduced in the routine immunisation programme of the government to do away with the risk of re-introduction of the disease. Health minister JP Nadda said that though India was certified polio-free on March 27, 2014, the battle against polio is not over yet.
“The virus is still active in our neighboring countries --Pakistan and Afghanistan. Cases of polio still happen there. So the risk of re-introduction of the disease remains, particularly through importation from these endemic countries,” he said.
“We are there to give them all kinds of support including technical, experience or vaccine-related assistance. But we will have to be vigilant till the virus is eradicated globally,” Nadda said at a function here to launch the vaccine.
“To ensure that our children are doubly protected from polio, the IPV is being introduced into the routine immunisation programme,” he said
In the first phase, the IPV injection is being introduced in six states - Assam, Bihar, Uttar Pradesh, Gujarat, Madhya Pradesh and Punjab.
However, the children will continue to receive OPV (polio drops) dose under routine immunisation and in pulse polio campaigns till they are 5 years of age.
“Even after receiving the IPV vaccine with the third dose of OPV (polio drops), the children must continue to receive OPV doses under routine immunisation and in pulse polio campaigns till they are five years of age,” health secretary BP Sharma said.
He said with the elimination of Type 2 polio from the country, the government is shifting from tOPV vaccine to bOPV vaccine in April 2016 and the introduction of new vaccine IPV in the immunization programme will reduce the risk associated with the shift.

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Sunday, 29 November 2015

New test may improve diagnosis of pancreatic cancers

New test may improve diagnosis of pancreatic cancers...
New test may improve diagnosis of pancreatic cancers
A 19-gauge EUS-FNA needle was advanced transhepatically into the portal vein and 2-4 aliquots of 8.5 mL of blood were aspirated. Image Credit: University of Chicago Medicine.
Scientists have developed a noninvasive, feasible and safe method to detect tumour cells in the pancreas and bile ducts, which could lead to early diagnosis for pancreatic cancer.
By collecting samples from the portal vein - which carries blood from the gastrointestinal tract, including from the pancreas, to the liver - physicians can learn far more about a patient's pancreatic cancer than by relying on peripheral blood from a more easily accessed vein in the arm, researchers from the University of Chicago in US have found. Primary tumours shed cancerous cells, known as circulating tumour cells (CTCs), into the blood. These have been widely studied as prognostic biomarkers for various cancers.
Since these cells are often larger, irregularly shaped and tend to cluster together, they get trapped in smaller vessels. The researchers hypothesised that most cells released from a gastrointestinal tumour would flow into the portal vein and then get sequestered by the narrow vessels in the liver. These cells would not reach the peripheral venous system.
CTCs from gastrointestinal tumours are rarely identified in the peripheral blood until the cancer is widely metastatic. To test this theory, researchers used an ultrasound-guided endoscope and a small needle to take blood from the portal vein during routine diagnostic endoscopies. They found CTCs in 100% of 18 patients with suspected tumours in the pancreas and bile ducts. Tests using peripheral blood samples, the standard method, detected tumours cells in only four of the 18 patients.
"We demonstrated that this method is potentially quite valuable as well as noninvasive, feasible and safe," said study director Irving Waxman, professor of medicine and surgery and director of the Centre for Endoscopic Research and Therapeutics at the university. "We had no complications related to portal vein blood acquisition," said Waxman.
Only 7% of patients diagnosed with stage II disease are still alive five years after diagnosis, making it one of the most lethal forms of cancer, the researchers said. The portal vein samples contained far more tumour cells in all stages evaluated, including locally advanced as well as metastatic tumours, the researchers said.
Blood collected from the portal vein had a mean of more than 100 CTCs per 7.5 millilitres. Patients with less advanced disease, who could potentially benefit from surgery to remove the tumour, had fewer CTCs. Those patients averaged about 80 CTCs per 7.5 millilitres. In contrast, when the researchers used peripheral blood to test the same patients, they found few, if any, circulating tumour cells.
Those samples contained less than one CTC in 7.5 millilitres of blood, the equivalent of one cell in a billion. The study was published in the journal Gastroenterology.

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Interview Related Information about Regulatory Affairs (RA) - Questions & Answers

Information about Regulatory Affairs (RA)

Full forms of some of the Abbreviations related to Regulatory Affairs-

New Drug Application
Abbreviated New Drug application
Investigational New Drug Application
Drug Master file
Active Substance Master File
Marketing Authorisation Application
Certificate of Suitability to the monographs of the European Pharmacopoeia
The International Conference on Harmonisation of technical requirements for registration of Pharmaceuticals for human use.
Common technical document
Applicant’s Part
Restricted Part
Open Part
Closed Part
New Molecular Entity
New Chemical Entity
Summary of Product Characteristics
Packaging Leaflet
Reference Member State
Concerned Member State
The Committee for Medicinal Products for Human Use
Committee for Proprietary Medicinal Products
Committee For Medicinal Products For Veterinary Use
Scale-up and post approval changes
Bulk Active Chemicals Post approval Changes
Current good Manufacturing Practice
Good clinical Practice
Good Laboratory Practice
Well known Drug Regulatory Agencies across the world-
Region Regulatory Agency
United States of America
United States Food and Drug Administration (USFDA)
United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA)
European Union
European Medicines Agency (EMA)
European Union
European Directorate for the Quality of Medicines (EDQM)
Therapeutic Goods Administration (TGA)
Therapeutic Products Directorate (TPD) in Health Product and food branch (HPFB) of Health Canada (HC)
Pharmaceutical and Medical Devices Agency (PMDA)
Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS)Translated into English as- French Agency for the Safety of Health Products
Drugs Controller General of India (DCGI) who heads Central Drugs Standard Control Organisation (CDSCO)
Swiss Agency for Therapeutic Products (SWISSMEDIC)
Health Sciences Authority (HSA)
Bundesinstitut für Arzneimittel und Medizinprodukte, (BfArM)
1.What is Regulatory Affairs?

Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.

2.What are the goals of Regulatory Affairs Professionals?

Protection of human health Ensuring safety, efficacy and quality of drugs Ensuring appropriateness and accuracy of product information

3.What are the Roles of Regulatory Affairs professionals?

Act as a liaison with regulatory agencies Preparation of organized and scientifically valid NDA, ANDA, INDA ,MAA, DMF submissions Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans Advising the companies on regulatory aspects and climate that would affect their proposed activities Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.

4.What is an Investigational New Drug (IND) application?

It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA.

5.What is a New Drug Application?

The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA in simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”

6.What is an Abbreviated New Drug Application (ANDA)?

It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.In simple words, “It is an application for the approval of Generic Drugs “

7.What is a Generic Drug Product?

A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

8.What is a DMF?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Important facts regarding  DMF. It is submitted to FDA to provide confidential information it's submission is not required by law or regulations it is neither approved nor disapproved it is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of theseIt is provided for in the 21 CFR (Code of Federal Regulations) 314. 420 It is not required when applicant references its own information.

9.What are the types of DMF’s?

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA).
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product 
Type III: Packaging Material 
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information (FDA discourages its use)

10.What is a 505 (b)(2) application ?

505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.

11.What kind of application can be submitted as a 505(b)(2) application?

New chemical entity (NCE)/new molecular entity (NME) Changes to previously approved drugs.

12. What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?

  • Change in dosage form.
  • Change in strength
  • Change in route of administration Substitution of an active ingredient in a formulation product
  • Change in formulation
  • Change in dosing regimen
  • Change in active ingredient New combination Product
  • New indication
  • Change from prescription indication to OTC indication
  • Naturally derived or recombinant active ingredient
  • Bioinequivalence
13.What are the chemical classification codes for NDA?

Number Meaning

1-New molecular entity (NME)
2-New ester, new salt, or other non-covalent derivative
3-New formulation
4-New combination
5-New manufacturer
6-New indication
7-Drug already marketed, but without an approved NDA
8-OTC (over-the-counter) switch

14.What are the differences between NDA and 505 (b)(2) application ?

New Drug Application (NDA)505 (b)(2) Application
1.All investigations relied on by applicant for approval were conducted by/for applicant and for which applicant has right of reference One or more investigation relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.
2.Generally, filed for newly invented pharmaceuticals.Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical.
Note: 505 (b)(2) application is a type of NDA.

15.What is a Marketing Authorization Application?

It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.As per UK’s MHRA-Applications for new active substances are described as 'full applications'.Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.

16.What is an ASMF?

Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.

17.What are the types of active substances for which ASMFs are submitted?

New active substances Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State

18.What is the difference between DMF and ASMF (with respect to submission)?

ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)There isn’t any differentiation of DMF’s into parts.

19.What is ICH?

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

20.What is CTD?

The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD. The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

21.What are the ICH guidelines to be referred for preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)?

  1. M4 Guideline
  2. M4Q Guideline
  3. M4S Guideline
  4. M4E Guideline

22.What are the modules in CTD?

The Common Technical Document is divided into five modules:

Module 1. Administrative information and prescribing information
Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
Module 3. Quality 
Module 4. Nonclinical Study Reports (toxicology studies)
Module 5. Clinical Study Reports (clinical studies).

23.What is Orange Book?

It is the commonly used name for the book “Approved Drug Products  Equivalence Evaluations”, which is published by USFDA. It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

24.What is Hatch-Waxman act?

It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics ”

25.What are the patent certifications under Hatch-Waxman act?

As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:
(I) that the required patent information relating to such patent has not been filed (Para I certification);
(II) that such patent has expired (Para II certification);
(III) that the patent will expire on a particular date (Para III certification); or(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.

26.What is meant by 180 day exclusivity?

The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium).

27.What are the procedures for Approval of Drug in EU?

  • Centralised Procedure (CP)
  • Decentralised Procedure (DCP)
  • Mutual Recognition Procedure (MRP)
  • National Procedure (NP)
28.What is the Full form of abbreviation, CEP?

Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs
It is also informally referred to as Certificate of Suitability (COS).

29.What is a CEP?

It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.

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