Monday, 30 December 2013

New blood test 'can detect risk of infection in minutes'

Scientists have created a device that is able to detect a person's risk of infection from a drop of blood within minutes, as opposed to current methods, which can take up to 2 hours. This is according to a study published in the journal Technology.
One common laboratory test to determine an individual's risk of infection is the counting of neutrophils in the blood, known as absolute neutrophil count.
Neutrophils are a type of white blood cell found in human blood. These are the "body's first line of defense" against inflammation and infection.
Within minutes of detecting infection, the neutrophils flee from the blood toward tissue, where they settle at the sites of infection.
"If neutrophils do not migrate well and cannot reach inside the tissues, this situation could have the same consequences as a low neutrophil count".
With this in mind, the investigators created a "miniaturized silicone-based device" that they say is able to measure migration patterns of neutrophils from a finger prick of blood, and this can be carried out within a matter of minutes.
The researchers say that methods currently used to measure the functions of neutrophils involve separating them from the blood. This process can take 2 hours, and the investigators say that the procedure needs to be conducted by skilled laboratory personnel. This, however poses a problem within clinical conditions, such as treating cases of patients with burn injuries, as the process is time-consuming and medical professionals' priorities change throughout the day.
"To address the need for rapid and robust assays, a microfluidic device was designed that measured neutrophil chemotaxis directly from a single droplet of blood.
By comparing neutrophil chemotaxis from finger prick, venous blood and purified neutrophil samples, it was found that average velocity of (19 ± 6 μm/min) and directionality (91.1%) between the three sources was consistent."
Hence it was concluded that being able to measure patients' risk of infections in a matter of minutes from only a droplet of blood is a "significant improvement and one that will improve current treatment."
Surgery 'better than chemotherapy' for tongue cancer

For the treatment of cancer, many would consider chemotherapy to be the best option. But for tongue cancer, new research suggests that surgery may be the most effective primary port of call.

The main treatment options for people with oral and oropharyngeal cancers include surgery (partial or full removal of the tongue for tongue cancer, followed by extensive reconstruction), radiation therapy, chemotherapy, targeted therapy and palliative treatment. These can be used alone or in combination.

Friday, 27 December 2013

Meditation May Aid Smoking Cessation Treatment

Meditation combined with medication and cognitive therapies may be more beneficial in treating nicotine addiction than drug-plus-talk therapy alone.

Thursday, 26 December 2013

Pallavi and Vikram of Batch-18, presented on the technical topic of European Regulatory (EMA).This presentation gave brief insight about the regulations for drugs and medical devices and also the approval procedures.

Tuesday, 24 December 2013

Walking lowers Cardiovascular disease [CVD] Risk in Patients with IGT [Impaired Glucose Tolerance].

In those with impaired glucose tolerance, walking just 2000 steps per day -- the equivalent of 20 minutes of walking at a moderate pace -- lowers CVD risk by 10%.

Monday, 23 December 2013

Stroke risks increase with high levels of anxiety

The negative health effects of anxiety, such as increased coronary heart disease risks, have long been documented and accepted in the medical community. But now, research suggests that individuals with high levels of anxiety have an increased risk for stroke.
A stroke occurs when blood flow to the brain stops, and this cuts off oxygen and nutrients that are vital for the brain. When this happens, brain cells die, and depending in which side of the brain the stroke occurs, effects can include paralysis, vision or speech problems, memory loss and behavioral changes.

Friday, 20 December 2013

Hybrid clotting factor means fewer injections, better disease control for hemophilia patients

A Phase III clinical trial led by UC Davis researchers has confirmed that a new coagulation factor (rFIXFc) dramatically reduces the number of injections needed to maintain effective clotting for HEMOPHILIA B patients.

The recombinant protein fuses clotting factor IX with an immunoglobulin (antibody) molecule, which prevents the body from rapidly metabolizing the hybrid protein. As a result, rFIXFc can be administered once a week, or even every two weeks, rather than every other (or every third) day. This extended half-life could have an enormous impact on hemophilia treatment. 

Thursday, 19 December 2013

An Apple (or Statin) a Day will keep the MD away

If individuals ate just one extra apple a day, approximately 8500 deaths from vascular disease could be prevented. 

Statins and apples are both iconic. "An apple a day is known throughout the English-speaking world as a saying for health, and statins are now some of the most widely prescribed drugs in the world. 

The new American College of Cardiology/ American Heart Association(ACC/AHA) guidelines for the management of cholesterol suggest treating primary-prevention patients if they have an LDL-cholesterol level between 70 and 189 mg/dL and a 10-year risk of atherosclerotic cardiovascular disease >7.5%. In the UK, the guidelines are less aggressive and recommend statin therapy for primary prevention of cardiovascular disease if the 10-year risk score is >20%.

Wednesday, 18 December 2013

                                            Role play - Trovan trial

          There was an outbreak of meninigococcal meningitis in Nigeria, Kano in 1996. It too almost 12,000 lives and affected close to 1,00,000 people in 6 months. Pfizer conducted trovan trial using trovafloxacin in IDH (Infectious Disease Hospital) recruiting 200 children without any informed consent forms, approval from ethics committee and regulatory authority; no GCP Guide lines were followed.

As a result of trial, 11 children died out of which 5 deaths were from trovan and many were left disabled. This was brought into light when it was published in an American journal and case was registered at U.S district court.

There was an out of the court settlement where Pfizer gave 175,000$ to 4 families based on DNA reports. Clinical trials have to be conducted on an ethical basis and government has to make sure that it is done in safe manner and for the benefits of people.


Tuesday, 17 December 2013

Role Play – A Tale of Two Cousins  

This role play enlightened about how sensitive clinical trials are, and focused on the real life story of two cousins (Brandon and Thomas) in lethal stages of melanoma. A tale of two cousins came into the media’s light due to the fact that were two drugs with different routes of administration that were used to treat melanoma, clinical trials were conducted to demonstrate the efficacy of drug PLX-4032 (wonder drug) in comparison to I.V Dacarbazine, a drug that already existed in the market and showed extremely poor results. In addition, the two cousins Brandon and Thomas were recruited into phase 3 of these trials, which were controlled and randomized, where it claimed the life of one of the cousins. The control arm (Brandon) was given I.V. Dacarbazine and the treatment arm (Thomas) was given PLX-4032 which was found to be effective in shrinking tumor sizes. The control arm faced death (Brandon) due to the ineffectiveness of the medicine. People concerned with the trial should be prudent and careful when designing the clinical trials. This created an uproar of ethical issues which involved the negligence of subjects when their quality of life should have been focused on. 
Update on ANZTPA Medical Device Regulatory Harmonization in Australia and New Zealand

Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries’ long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

  • First, the Australian Therapeutic Goods Administration [TGA] and New Zealand's Medsafe have set up a Joint Adverse Event Notifications System (JAENS) to inform each other of adverse events occurring in their respective markets.
  • Second, the two regulators have begun an early-warning system to alert healthcare providers in both countries of safety issues involving drugs and medical devices.
  • Third, the TGA and Medsafe have launched a Recall Portal that provides publically available recall action data on devices and drugs in Australia and New Zealand.
  • Fourth, the regulators have developed a joint capability for Good Manufacturing Practice inspections in both markets. However, the TGA and Medsafe are still working on final development and implementation of a single GMP Inspection and Licensing system expected to go live once the ANZTPA is fully operational.

Monday, 16 December 2013

FDA Approves First Device to Treat Migraine Pain

“Millions of people suffer from migraines, and this new device represents a new treatment option for some patients".
The device is used by prescription after onset of pain associated with migraine with aura. Using both hands, the patient holds the device to the back of the head and, pressing a button, releases a pulse of magnetic energy that stimulates the occipital cortex, stopping or reducing the pain associated with this type of migraine. The recommended daily usage of the device is not to exceed 1 treatment in 24 hours.

Friday, 13 December 2013

Clinical research is the next big thing in developing India

By 2020, India will be among the top five countries for clinical research. It is one of the fastest growing sectors.

Currently, India ranks 14 in the clinical research market, but will soon be among the top. It's the next big thing in India. Other leading Asian countries are China and Korea. According to ISCR, the economic slowdown affected the industry in the initial four months. The industry has picked up over the past nine months.

Thursday, 12 December 2013

Update on US FDA Unique Device Identification Submission System

The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.

Manufacturers with US medical device market authorization are required to submit device identification data into a Global Unique Device Identification Database (GUDID) managed by the FDA. Firms now have two options for submitting information to the GUDID: a GUDID Web Interface that requires users to set up GUDID accounts, and an HL7 SPL option for submitting device information via xml file one record at a time.
Submitting a device information record using the HL7 SP option requires firms to establish GUDID accounts and send xml files through the FDA Electronic Submissions Gateway.

Wednesday, 11 December 2013

Oxytocin 'Normalizes' Social Deficits in Kids With Autism

A single dose of the hormone oxytocin administered via nasal spray enhances brain activity in key regions, temporarily improving social information processing in children with autism spectrum disorder (ASD).

Tuesday, 10 December 2013

Smoking Pot May Double Risk for Stillbirth
Cannabis (tetrahydrocannabinolic acid), smoking, illicit drug use, and secondhand smoke exposure are linked to increased risk for stillbirth twofold. Secondhand smoke alone also almost doubled the odds of stillbirth.

Monday, 9 December 2013

FDA and EMEA approve of Game Changer Sofosbuvir 

 Sofosbuvir is a first-in-class polymerase inhibitor that allows for   all-oral, interferon-free therapy for some patients with hepatitis  C and reduced treatment time for most.

The US Food and Drug Administration (FDA) has approved the first-in-kind nuceotide analog inhibitor sofosbuvir (Sovaldi, Gilead Sciences, Inc) for the treatment of adults with chronic hepatitis C virus (HCV) infection, a widely anticipated move that is expected to dramatically improve outcomes for many patients.

The European Medicines Agency's Committee for Medicinal Products for Human use (CHMP) has recommended granting a marketing authorisation for Sovaldi (sofosbuvir), for use 'in combination with other medicinal products for the treatment of chronic (long-term) hepatitis C in adults'.

Friday, 6 December 2013

Clobazam (Onfi) Can Cause Serious Skin Reactions, FDA Warns 

The antiseizure drug clobazam (Onfi, Lundbeck) can trigger rare but potentially fatal skin reactions, the US Food and Drug Administration (FDA) announced today.
For clobazam, the skin reactions to watch for are Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Patients taking clobazam can experience these disorders at any time, but the risk goes up during the first 8 weeks of treatment or when treatment resumes after it was stopped. All the cases of these 2 adverse events identified by the FDA landed patients in the hospital, with 1 patient going blind and another dying.

Thursday, 5 December 2013

Oral Cancer Screening

Squamous cell carcinoma accounts for 90% of all cases of oral cavity and pharyngeal cancer. More than half of persons with oral and pharyngeal cancer have regional or distant metastases when they are first diagnosed. The USPSTF therefore stated that screening for oral cancer may be helpful if potentially malignant disorders can be identified earlier and treated successfully.


Thursday, 28 November 2013

Tuesday, 26 November 2013

ACRI - PGDCR Batch 17 Presentation

Amresh of batch 17, presented the topic of orphan drugs. This presentation was very instructive and covered all the sockets of regulations and incentives in different countries for orphan drugs.

Saturday, 19 October 2013

Indian Pharma Sector India's pharmaceutical sector is gaining its position as a global leader

Indian Pharma Sector India's pharmaceutical sector is gaining its position as a global leader, poised to grow from US21.7 currently, to US$ 36.7 billion by 2015. A PricewaterhouseCoopers (PwC) report says it could touch US$ 74 billion by 2020. This is in league with Indian Government's Pharma Vision 2020 which aims at making India a global leader in end-to-end manufacture by 2020, and is planning to set up US$ 640 million VC to boost drug discovery and strengthen the pharmaceutical sector. The Indian Pharma sector produces 600 Generic brands, 600 therapeutic categories, and manufactures more than 500 different APIs. While Generics continue to dominate the market; patent-protected products are expected to constitute 10 per cent of the pie till 2015. Several multinationals are already set to launch patented drugs across India. The demand for high end drugs in rural India is estimated to grow to US$ 8 million by 2015, wherein 70% of India's populace resides. Efforts are being made to reach chemists and OTC drugs to the rural populace through expanding networks. The clinical trials market was US$ 400 million in 2009 and India is expected to remain a valuable investment hub due to its genetically diverse population and availability of skilled doctors. In field of health insurance, 650 million people are expected get health insurance cover by 2020, painting a rosy picture of the Indian Pharma Industry as a whole.

Sunday, 6 October 2013

Treatment For Pediatric Migraine

Propofol May Be An Effective Treatment For Pediatric Migraine.

Medscape (10/2, Lowry) reports that at the American Academy of Pain Management 24th Annual Clinical Meeting, “researchers report[ed] that subanesthetic doses of propofol provide a safe and effective abortive treatment for pediatric migraine.” Investigators found that, “compared with the children who received standard abortive migraine therapy,” those who received “propofol achieved significantly greater reduction in pain scores as measured on a self-reported visual analogue scale (VAS).”

Friday, 20 September 2013

Great News from ACRI India Placement Division

75% of previous batch students have been placed, with highest pay package of 4.5 and 4.0 Lakh PA respectively. Moreover the entire 75% candidates are placed in tier 1, MNC companies only. 25% of the students have been offered more than 4 Interview chances and they are still being assisted. 55% of the current batch has been placed even before the course completion.

Thursday, 19 September 2013

Tuesday, 17 September 2013

ACRI Workshop in news paper

News paper coverage about ACRI India Clinical Research Institute's workshop on 14th September 2013.

Saturday, 14 September 2013

ACRI INDIA Clinical Research Workshop on Advances in Clinical Research and Pharmacovigilance

ACRI India Clinical Research Institute hosts a day-long workshop to educate medical professionals and students on recent advances in Clinical Research and Pharmacovigilance
Bangalore, 14th September 2013: Bangalore-based ACRI India Clinical Research Institute, today conducted a day-long workshop on “Advances in Clinical Trials and Pharmacovigilance” for medical professionals and students from allied health science and life science. The workshop was inaugurated by  Ms Anuradha Ramachandran, Director, ACRI.
The idea to conduct this workshop was conceived to provide the latest trends seen in clinical research and Pharmacovigilance. The workshop witnessed overwhelming participants which in turn reflects the growing interest among doctors and life science graduates in choosing Clinical Research as new career arena.

The day-long workshop was divided into two sessions chaired by Dr Smita Singh, Head of Academics, ACRI and Dr Nisha Nair, an Industry Expert in PV. The first session was mentored by Dr Singh who took the participants on a tour of clinical research by capturing the various steps involved in a drug development in a presentation. Participants were provided with an introduction to Clinical research, followed by drug discovery procedures, good clinical practices and regulatory requirements for drug approval.

At the second session, Dr Nair focused on the current Indian Pharmacovigilance system, importance of Pharmacovigilance in clinical research and advancement required to gain World-wide credit. The session also highlighted other fundamentals of Pharmacovigilance system, such as science of detection, assessment, understanding and prevention of adverse events, reporting systems for adverse events and narrative writing.
The workshop was successfully concluded by furnishing the participants instructive and informative nuances of clinical research. At the end, certificates were handed over to the participants confirming them as ‘GCP trained’ which enable participants to further apply for Clinical Research profiles in CROs ( Contract Research Organization) with the knowledge acquired during the workshop.
ACRI India Clinical Research: is modeled on the lines of some of the premier Clinical Research Institutes of India. We are dedicated and committed to provide excellent Clinical Research Professionals to the Clinical Research Industries. At ACRI, we offer job oriented courses viz., “PG Diploma in Clinical Research” “Clinical Data Management” & “Clinical SAS Programming”

For more information please visit or call us at +91 9741 600 499 

Friday, 14 June 2013

Most preferred online course


ACRI's online course "PG Diploma in Investigator's Responibilities"  is the most preferred course among all the Doctors viz., MBBS, BDS, BAMS, BPT & BHMS.

We are the only institute providing online course for Investigator’s responsibility.

Wednesday, 5 June 2013

Market Research Estimates the Central Laboratory Market at $1.5 Billion

Today much of the clinical development of new drugs is outsourced by the pharmaceutical industry. This outsourcing is managed by hundreds of contract research organizations world-wide ranging from global industry leaders such as Covance to small two person niche companies. The proportion of the work outsourced continues to grow at a healthy double digit rate and today approaches 30% on average. Laboratory pathology analysis of blood, urine and other patient specimens is on the other hand, outsourced at a virtually 100% level with few parameters, usually biomarkers, being analyzed in the pharmaceutical companies' laboratories.

The central laboratory business is by its very nature a global business now that the pharmaceutical industry has moved to global drug development. Unlike contract research organizations a small pathology laboratory cannot compete and the vast majority of the business is concentrated in the hands of relatively few, perhaps 20, large players.

Choosing a central laboratory and then contracting with it are vital to the successful outcome of a clinical trial
Selecting Preferred Providers.

While choosing a laboratory to conduct a specific study, following points should be kept in mind:
  •  Favorable pricing and better service.
  •  Quality assurance & Quality control.
  •  Data Management.
  • Single lab for all studies.
  • Financial Stabilit.
  • A Dedicated tea.
  • Technical expertise and experience Support the launch of a test
Defining Expectations

Once a central laboratory has been selected, the success of the relationship will be largely determined before the first sample is delivered. It is important to define performance expectations at the outset of the relationship through mutual planning. Periodic meetings between the sponsor and laboratory provide opportunities for addressing measurements and discussing areas for improvement across all ongoing studies.

Here are some examples of expectations that could be set before the first study begins:

Sponsors should provide all necessary information to their laboratory four to six weeks in advance, thereby giving the laboratory ample time to set up the study properly. The first three weeks of the setup process will largely determine how smoothly it runs. There is no surer way to compromise a study than to give your central laboratory a week to set it up. After a study has been set up, it is vitally important that the sponsor make few if any changes, since they can have a cascading effect on all aspects of the trial.

Data file setup, including formatting, must be determined, which typically requires the laboratory to develop and submit a dummy file showing how data for all patients and all visits will be presented. This often requires the laboratory to facilitate communication between a sponsor’s clinical and data management personnel. Data cleanliness is essentially the byproduct of continuous improvement. The ultimate objective being a clean set of data for database lock at the end of the study. If a study requires development of new methods, the sponsor should give the central laboratory sufficient advance notice. The process is usually time-consuming and cannot be completed in a month.

Typically laboratories require advance notice for replenishment; participating physicians cannot realistically expect quality kits containing all the necessary contents and paperwork to be consistently delivered in 24 hours.
Following are some of the examples of Central Lab

Lab Corp

Thursday, 23 May 2013

Recently Launched US website makes clinical trials easy to find

A US doctor has Launched a website to make it easier for the world’s sickest people to connect with research that could potentially save their lives.

The non-profit endeavor known as aims to become "The Wikipedia of clinical trials," by allowing a quick and free search for studies at academic centers around the globe, said its founder Bruce Markowitz is “really a resource for everybody, worldwide,  for free,” said Moskowitz, a primary care physician in Palm Beach, Florida,  whose mobile patient population -many of whom migrate north for the summer  gave him the idea of finding better ways to share information.

Moskowitz hopes that the new website will improve the quality of research and also helps to identify how many clinical trials are duplicated.

The new web site is an open-source platform, so educational centers can send in their own information. It updates automatically and can send users alerts when a trial status changes or a new trial opens up.    It also allows patients to email a doctor in any country to find out about a clinical trial, Moskowitz said.

Thursday, 16 May 2013

Role of Preclinical Toxicology studies in Clinical Research


Preclinical studies are carried out on animal models prior to the onset of clinical trials in humans. Various parameters need to be considered in preclinical studies before the drug is actually tested on humans. Important factors include pharmacokinetics data, pharmacodynamics data, drug safety and toxicology data. The goals of preclinical studies include: predicting the safety, efficacy, toxic effects, dose dependence and further to extrapolate it for potential human outcome.


Preclinical phase is the stage of drug development process that begins before clinical trial actually starts during which the feasibility, iterative testing and drug safety data are collected. Other non clinical studies include pharmacology studies for safety assessment [safety pharmacology] and pharmacokinetic [ADME] studies. The above mentioned studies provide a myriad of information about the drug and how they might act during clinical trials. Drugs will undergo PK, PD and toxicity studies through animal testing.

Importance of Pharmacokinetics and Pharmacodynamics data:

Absorption [A]:
  • Helps to decide on routes of administration.
  • Helps to decide on dosage level.
Distribution [D]:
  • Helps to know the impact the drug has created
  • Helps to study the Bioavailability of the drug [rate of bound and unbound drug]

Metabolism [M]:

Conjugation Data ,Cumulative effect, Therapeutic effect, Toxic effect.

Excretion [E]:

Helps to know the excretion rate of the drug from the body.

Some other parameters which could be derived from PK/PD studies are efficacy, potency, drug concentration levels in plasma, cmax, tmax, bioavailability and t1/2 life. Secondary parameters include data on AUC [Area under the Curve] which is a measurement of how much drug is absorbed by the body and how easily it is eliminated. Pharmacodynamics studies also gives data about permeability of barrier, pH and binding capacity.

Preclinical toxicology studies:

Invitro tests are used to evaluate the long term safety of a drug. It helps to determine specific properties of a drug and also helps to assess mutagenic and carcinogenic effects leading to toxicity. Toxicological activity of the products can be determined using invitro and invivo assay methods which estimate the clinical relatedness of the toxicological effects of the drug.

(i) Invitro methods:

Objective: To study the action of the test drug in tissues and cells from different organisms. This helps to study the mutagenic and carcinogenic property of a drug.

Tissues from several species including man can be examined and it also helps to reduce the number of animal tests required for screening new drugs. These studies help us to know certain factors like genotoxicity and mutagenicity. Genotoxicity refers to the study of toxic effects of the drugs on genetic/molecular level. The methods used in genotoxicity studies are molecular profiling and whole genome analysis.

High throughput profiling of a gene or a protein could reveal if there are any potential changes in the chromosome and DNA activity in using a drug. For e.g.: In humans, SNP [single Nucleotide Polymorphisms] are observed in which a single gene / base pair differ from another human. Studies are carried out to see the effect of drug on SNP’s, Haplotype genes etc using marker analysis.

Other studies are conducted specifically on microorganisms. To determine antibacterial property of a drug, few assays used include: Bacterial Reverse Mutation tests [AMES test], E.coli Reverse Mutation Assay, Invitro mammalian chromosome aberration test, Invitro mammalian cell gene mutation test.

Assay studies are conducted on microorganisms like Salmonella typhymurium, Escherichia coli and yeast. Mammalian cells used are mouse myeloma cells, Chinese hamster ovary [CHO] cells and also fully sequenced organism like Drosophia melanogaster [fruit fly].

(ii) Invivo methods:

Objective: The main objective of carrying our invivo studies are to determine the qualitative and quantitative analysis of how the drug acts on a body and the prime determining factor being the drug safety. The studies that are carried out inside an animal model is referred to as invivo studies. The choices of animal model play a major role in these types of studies.

Choice of model organisms: Differences in gut enzyme activity and circulatory system makes certain models more appropriate based on dosage forms. For e.g., canines are good models for solid oral dosage forms because carnivore intestine is underdeveloped compared to omnivores and gastric emptying rates are high. Also rodents cannot act as models for antibiotic drugs because alteration of intestinal flora causes significant adverse effects.

Depending on the drugs functional group it may be metabolized in similar or different ways between species which will affect both efficacy and toxicology. Some commonly used traits are: those animals which breed faster, easily availability, low cost in growing and housing, and selecting animals for which biological profile information is already available and are already proven to be model animals.

Ethical issues: 

Invivo studies are carried out abiding to certain guidelines put forth by PETA [People for the Ethical Treatment of Animals] which states that animals should to be treated respectfully.

The invivo studies can be carried out to determine the following factors:

Objective: To determine the safest dose to be administered. The study gives the results for MTD [Maximum tolerated dose] and NOAEL [Non Observed Adverse Effect Limit].


Raji Radhakrishnan S (Student of ACRI)

Tejeswani (Academic Coordinator)

Dr Smita Singh (Head of Academics)