Friday, 8 July 2016

Eat Curd Daily: It May Reduce Breast Cancer Risk

Eat Curd Daily: It May Reduce Breast Cancer Risk

Intake of probiotics may help increase the proportion of beneficial bacteria in the breast and thus aid in preventing the risk of breast cancer.

The findings showed that Lactobacillus and Streptococcus—considered to be health-promoting bacteria —were more prevalent in healthy breasts than in cancerous ones. Both groups have anti-carcinogenic properties.

A new study, published in the journal Applied and Environmental Microbiology, shows that regular consumption of probiotics may help increase the proportion of beneficial bacteria in the breast and thus aid in preventing the risk of breast cancer. Lactobacillus and Streptococcus are considered to be health-promoting bacteria and these were more prevalent in healthy breasts than in cancerous ones. Both groups of bacteria are known to have anti-carcinogenic properties.
In the study, the team obtained breast tissues from 58 women who were undergoing lumpectomies or mastectomies for either benign (13 women) or cancerous (45 women) tumours, as well as from 23 healthy women who had undergone breast reductions or enhancements.

"Our work shows that women, especially those at a higher risk for breast cancer, take probiotic lactobacilli to increase the proportion of beneficial bacteria in the breast," said Gregor Reid, Professor at Western University in Canada. Conversely, women with breast cancer also showed elevated levels of Escherichia coli and Staphylococcus epidermidis, the harmful bacteria, known to induce double-stranded breaks in DNA in HeLa cells (cultured human cells)

ICH guidelines ICH GCP guidelines

ICH guidelines



The rights, safety, and well being of the trial subjects are the most important considerations & should prevail over interests of science and society.
  1. The available nonclinical & clinical information on an investigational product should be adequate support the proposed clinical trial.
  2. Clinical trials should be scientifically sound, & described in a clear, detailed protocol; which has received prior IRB/IEC approval
  3. The medical care and medical decisions for subjects should be the responsibility of a qualified physician
  4. Each individual involved in conducting a trial should be qualified by education, training & experience to perform his respective task
  5. Freely given informed consent should be obtained from every subject prior to clinical trial participation
  6. All clinical information should be recorded, handled, and stored in a way that allows its  accurate reporting, interpretation and verification
  7. The confidentiality of records that could identify patients should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements
  8. Investigational products should be manufactured, handled and stored in accordance with applicable GMP, and used in accordance with the protocol
  9. Systems with procedures that assure the quality of every aspect of the trial should be implemented



ICH GCP guidelines


  1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the regulatory requirement(s)
  2. Before a trial is initiated, foreseeable risks and inconveniences should beweighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks
  3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society
  4. The available pre-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial
  5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol
  6. A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board/Independent Ethics Committee (IRB/IEC) approval/favorable opinion
  7. The medical care given to and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist
  8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)
  9. Freely given informed consent should be obtained from every subject prior to clinical trial participation
  10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification
  11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)
  12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol
  13. Systems with procedures that ensure the quality of every aspect of the trial should be implemented.


New and Generic Drug Approvals

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CubicindaptomycinPowder;IntravenousCubistLabeling Revision
CubicindaptomycinPowder;Iv (Infusion)CubistLabeling Revision
EltrombopageltrombopagTablet;OralHetero Labs Ltd VTentative Approval
HabitrolnicotineFilm, Extended Release; TransdermalDr Reddys Labs IncLabeling Revision
HabitrolnicotineFilm, Extended Release;TransdermalDr Reddys Labs IncLabeling Revision
XolairomalizumabVialGenentechEfficacy Supplement with Clinical Data to Support

July 5, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
HabitrolnicotineFilm, Extended Release; TransdermalDr Reddys Labs IncLabeling Revision
HabitrolnicotineFilm, Extended Release;TransdermalDr Reddys Labs IncLabeling Revision
Hydrocodone Bitartrate and Acetaminophenacetaminophen; hydrocodone bitartrateTablet;OralPar PharmApproval
Methenamine Hippuratemethenamine hippurateTablet;OralAurobindo Pharma LtdApproval
Pravacholpravastatin sodiumTablet;OralBristol Myers SquibbLabeling Revision
Tobramycin Sulfatetobramycin sulfateInjectable;InjectionClarisApproval

July 1, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Evotazatazanavir sulfate; cobicistatTablet;OralBristol Myers SquibbLabeling Revision
FebuxostatfebuxostatTablet;OralAlembic Pharms LtdTentative Approval
KepivancepaliferminInjectable; InjectionBiovitrum AbLabeling Revision
SyndrosdronabinolSolution;OralInsys Dev Co IncLabeling Revision

June 30, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ethacrynic Acidethacrynic acidTablet;OralEdenbridge PharmsApproval
HumiraadalimumabSyringeAbbvie IncEfficacy Supplement with Clinical Data to Support
HumiraadalimumabVialAbbvie IncEfficacy Supplement with Clinical Data to Support
Hydromorphone Hydrochloridehydromorphone hydrochlorideTablet, Extended Release;OralActavis Labs Fl IncManufacturing Change or Addition
MobicmeloxicamTablet;OralBoehringer IngelheimLabeling Revision
Olmesartan Medoxomilolmesartan medoxomilTablet;OralAlkem Labs LtdTentative Approval
PomalystpomalidomideCapsule;OralCelgeneLabeling Revision

June 29, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Levothyroxine Sodiumlevothyroxine sodiumPowder;IntravenousFera Pharms LlcApproval
Naloxone Hydrochloridenaloxone hydrochlorideInjectable;InjectionMylan InstitutionalApproval
NeupogenfilgrastimSyringeAmgenSupplement
NeupogenfilgrastimVialAmgenSupplement
TygaciltigecyclineInjectable;Iv (Infusion)Pf Prism CvLabeling Revision

June 28, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Epclusasofosbuvir; velpatasvirTablet;OralGilead Sciences IncApproval
ImbruvicaibrutinibCapsule;OralPharmacyclics IncLabeling Revision

Clinical Research Versus Medical Treatment

What is clinical research?

Clinical research refers to studies in which people participate as patients or volunteers. Different terms are used to describe clinical research, including:
  • clinical studies
  • clinical trials
  • studies                                                    
  • research
  • trials
  • protocols.
Clinical research may have a number of goals, such as:
  • developing new treatments or medications        
  • identifying causes of illness
  • studying trends
  • evaluating ways in which genetics may be related to an illness.
The idea for a clinical research study—also known as a clinical trial—often originates in the laboratory. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.
Strict rules for clinical studies have been put in place by National Institutes of Health and the FDA. Some studies involve promising new treatments that may directly benefit participants. Others do not directly benefit participants, but may help scientists learn better ways to help people.
Confidentiality is an important part of clinical research and ensures that personal information is seen only by those authorized to have access. It also means that the personal identity and all medical information of clinical trial participants is known only to the individual patient and researchers. Results from a study will usually be presented only in terms of trends or overall findings and will not mention specific participants.
Clinical research is much different from the medical treatment you receive in a Healthcare Provider's office.
Clinical Research Versus Medical Treatment
Clinical ResearchMedical Treatment
IntentAnswers specific questions through research involving numerous research volunteers.Addresses the needs of individual patients.
Intended BenefitGenerally designed and intended to benefit future patients.Intended to benefit the individual patient.
FundingPaid for by drug developers and Government agencies.Funded by individual patients and their health plans.
TimeframeDepends on research protocols.Requires real-time decisions.
ConsentRequires written informed consent.May or may not require informed consent.
AssessmentInvolves periodic and systematic assessment of patient data.Based on as-needed patient assessment.
ProtectionsProtected by government agencies, institutional review boards, professional standards, informed consent, and legal standards.Guided by state boards of medical practice, professional standards, peer review, informed consent, and legal standards.
CertaintyTests products and procedures of unproven benefit to the patient.Uses products and procedures accepted by the medical community as safe and effective.
Access to InformationConsidered confidential intellectual property.Available to the general public through product labeling.
Release of FindingsPublished in medical journals, after clinical research ends.Individual medical records are not released to the general public.

Who should consider clinical trials and why?

Some people participate in clinical trials because none of the standard (approved) treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.
All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments.  FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Learn more about FDA’s efforts to increase diversity in clinical trials.

Where are clinical trials conducted?

Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers). The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

Are clinical trials safe?

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

What should I think about before joining a clinical trial?

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:
  • what happens during the trial
  • the type of health care you will receive
  • any related costs once you are enrolled in the trial
  • the benefits and risks associated with participating. 

What is FDA’s role in approving new drugs and medical treatments?

FDA makes sure medical treatments are safe and effective for people to use. We do not develop new therapies or conduct clinical trials. Rather, we oversee the people who do. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data.

Where can I find clinical trials?

One good way to find out if there are any clinical trials that might help you is to ask your doctor. Other sources of information include:
  • FDA Clinical Trials Search. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn about each trial’s purpose, who can participate, locations, and who to contact for more information.
  • Clinicaltrials.gov. Conduct more advanced searches
  • National Cancer Institute or call 1–800–4–CANCER (1–800–422–6237). Learn about clinical trials for people with cancer.
  • AIDSinfo. Search a database of HIV/AIDS trials, sponsored by the National Institutes of Health’s National Library of Medicine.

What is a placebo and how is it related to clinical trials?

A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill. In clinical trials, experimental drugs are often compared with placebos to evaluate the treatment’s effectiveness.

Is there a chance I might get a placebo?

In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug. Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups. In these cases, all participants receive the experimental drug. Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. Then, talk with your doctor about what is best for you.

How do I find out what Phase a drug is in as part of the clinical trial?

Talk to the clinical trial coordinator to find out which phase the clinical trial is in. Learn more about the differentclinical trial phases and whether they are right for you.

What happens to drugs that don't make it out of clinical trials?

Most drugs that undergo preclinical (animal) research never even make it to human testing and review by the FDA. The drug developers go back to begin the development process using what they learned during with their preclinical research

what is Allergy



An affectability(allergy)  is a reaction the body has to a particular sustenance or substance.

Sensitivities are to an uncommon degree common. They're thought to impact more than one in four people in the UK as time goes on in their lives. 
They are particularly standard in teenagers. A couple of sensitivities leave as a child gets more organized, yet diverse are strong. Adults can make hypersensitivities to things they weren't up to this time delicate to. 

Having an affectability can be an injury and impact your customary activities, yet most unfavorably frail reactions are smooth and can be for the most part kept under control. True blue reactions can sporadically happen, yet these are remarkable. 


Key hypersensitivities 

Substances that cause unfavorably unprotected reactions are called allergens. The more normal allergens include: 

  • grass and tree dust – an affectability to these is known as sustenance fever (unfavorably unprotected rhinitis) 
  • dust vermin 
  • animal dander (unassuming bits of skin or hair) 
  • sustenance – particularly nuts, basic thing, shellfish, eggs and dairy creatures' milk 
  • bug eats and stings 
  • pharmaceutical – including ibuprofen, migraine medication, and certain executing experts hurts 
  • latex – used to make a few gloves and condoms 
  • mold – these can release little particles into the air that you can take in 
  • family chemicals – entwining those in chemicals and hair tints 

A substantial segment of these allergens are all things considered ensured to people who aren't unreasonably influenced by them. 

Signs of an unfavorably vulnerable reaction 

Unfavorably vulnerable reactions generally speaking happen quickly inside a couple of minutes of prelude to an allergen. 

They can fulfill: 

  • wheezing 
  • a runny or blocked nose 
  • red, maddening, watery eyes 
  • wheezing and hacking 
  • a red, maddening rash 
  • maddening of asthma or skin annoying symptoms 

Most touchy reactions are smooth, yet on occasion a veritable reaction called unrestrained shakiness or anaphylactic daze can happen. This is a therapeutic emergency and necessities crucial treatment. 

Inspected more about the signs of hypersensitivities. 

Getting help for sensitivities 

See your GP if you think you or your youth may have had an unfavorably defenseless reaction to something. 

The signs of an unfavorably powerless reaction can in like way be expert by various conditions. Your GP can understand in the event that it's persuading you have an affectability. 

If your GP expect you may have a delicate awesome unsteadiness, they can offer comprehension and treatment to manage the condition. 

If your over the top sensitivity is particularly persuading or it's not clear what you're antagonistically affected by, your GP may propose you to an affectability master to test and bearing about treatment. 

Analyzed more about affectability testing. 

Controlled guidelines to manage an over the top affectability 

As a rule, the best technique for managing an over the top dubiousness is to evade the allergen that causes the reaction at whatever point possible. 

For instance, in case you have a sustenance awesome sensitivity, you should check a reinforce's fixings list for allergens before eating it. The Food Standards Agency has more information about sustenance allergen naming. 

There are in like way a couple of medicines available to control signs of unfavorably powerless reactions, including: 

  • antihistamines – these can be taken when you see the signs of a reaction, or before being appeared to an allergen to stop a reaction happening 
  • decongestants – tablets, compartments, nasal sprinkles or liquids that can be used as a passing treatment for a blocked nose 
  • demulcents and creams, for case, submerging creams (emollients) – these can diminish skin redness and unsettling impact 
  • steroid strategy – sprinkles, drops, creams, inhalers and tablets that can diminish redness and swelling finished by an unfavorably fragile reaction 

For a few people with to an unprecedented degree genuine sensitivities, a treatment called immunotherapy may be recommended. 

This combines being appeared to the allergen controlledly over different years, so your body gets usual to it and doesn't react to it so to a phenomenal degree. 

Analyzed more about treating a shakiness and keeping up a fundamental division from unfavorably weak reactions. 

What causes hypersensitivities? 

Sensitivities happen when the body's sheltered structure reacts to a particular substance generally as it's unsafe. 

It's not clear why this happens, yet genuinely most by far impacted have a family history of sensitivities or have unequivocally related conditions, for event, asthma or skin exacerbation. 

The measure of people with sensitivities is building up every year. The clarifications for this are not saw, yet rather one of the indispensable hypotheses is it's the consequence of living in a cleaner, sans germ environment, which diminishes the measure of germs our shielded structure needs to oversee. 

It's thought this may make it overcompensate when it comes into contact with safe substances. 

Is it an astounding precariousness, affectability or inclination? 

  • affectability – a reaction went on by the body's insusceptible structure when appeared to a reliably safe substance 
  • affectability – the adornment of the standard effects of a substance; for occasion, the caffeine in some coffee may perform stunning signs, for instance, palpitations and trembling 
  • radicalism – where a substance causes unpalatable signs, for case, partition of the guts, yet prohibits the sheltered system; people with a slant to particular sustenances can regularly eat to some degree all out without having any issues