the quarterly newsletter from the corporate of …...of aurous healthcare -- cro.cro. an alumni of...
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Jun 2017 Jun 2017 Vol.04 Ed.04Vol.04 Ed.04 The Quarterly Newsletter from the Corporate of Aurous HealthCare The Quarterly Newsletter from the Corporate of Aurous HealthCare The Quarterly Newsletter from the Corporate of Aurous HealthCare --- CRO…CRO…CRO…
http://auroushealthcare.wordpress.com/drhttp://auroushealthcare.wordpress.com/dr--vtvt--sriraam/ sriraam/
D r . V T . S r i r a a m M B B S M D D r . V T . S r i r a a m M B B S M D
(Pharmacology) is the founder(Pharmacology) is the founder –– director director
of Aurous HealthCare of Aurous HealthCare -- CRO.CRO.
An alumni of Stanley Medical College, he was An alumni of Stanley Medical College, he was
honored as “The Best Doctor” by the Ministry of honored as “The Best Doctor” by the Ministry of
Health, Maldives at the age of 23. Health, Maldives at the age of 23.
Gaining rich and varied experience at top CRO, Gaining rich and varied experience at top CRO,
Dr. VT. Sriraam founded Aurous HealthCare in Dr. VT. Sriraam founded Aurous HealthCare in
2008. An astute medical entrepreneur, his sharp 2008. An astute medical entrepreneur, his sharp
business sense combined with his rich knowledge business sense combined with his rich knowledge
and experience in the field of clinical research and experience in the field of clinical research
has pushed Aurous HealthCare from strength to has pushed Aurous HealthCare from strength to
strength. strength.
Dr.Sriraam has been recognized with Dr.Sriraam has been recognized with
NATIONAL AWARD NATIONAL AWARD -- “Indian Leadership “Indian Leadership
Award for Healthcare Excellence”, Award for Healthcare Excellence”, for for
his contributions in the field of medical his contributions in the field of medical
researchresearch
A man with strengths so varied and unique, A man with strengths so varied and unique,
Dr.VT.Sriraam is the epitome of the Dr.VT.Sriraam is the epitome of the
entrepreneurial combination of business brains entrepreneurial combination of business brains
and clinicaland clinical--research creatives.research creatives.
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From the Desk of MD…From the Desk of MD… Dear Colleagues and Friends,Dear Colleagues and Friends,
The Clinical Research Special Edition.The Clinical Research Special Edition. Every field has its nuances and experts. A decade ago, the field of clinical Every field has its nuances and experts. A decade ago, the field of clinical research was looked upon either as “gross human experiments” or just plain research was looked upon either as “gross human experiments” or just plain expenses.expenses.
Today, CDSCO along with other Drug Regulatory of the World insists on Today, CDSCO along with other Drug Regulatory of the World insists on Clinical Trials to prove the safety and efficacy of an investigational product, Clinical Trials to prove the safety and efficacy of an investigational product, before marketing.before marketing.
Apart from ethics, there are various dimensions, rules, mandates and Apart from ethics, there are various dimensions, rules, mandates and guidelines that one has to keep in mind even while designing a clinical trial.guidelines that one has to keep in mind even while designing a clinical trial.
The objective of every clinical trial designed byThe objective of every clinical trial designed by Aurous HealthCare CRO Aurous HealthCare CRO is not just to validate the safety and efficacy of the product, but also work is not just to validate the safety and efficacy of the product, but also work towards understanding compliance, patient feedback and observations to the towards understanding compliance, patient feedback and observations to the client to aid them with comprehensive product placement and effective client to aid them with comprehensive product placement and effective marketing.marketing.
Visit AuroBlog & click on category Visit AuroBlog & click on category -- “Learn Clinical Research” “Learn Clinical Research” for the basics of Clinical Research and terminologies.for the basics of Clinical Research and terminologies.
With best regards,With best regards,
Dr. VT.Sriraam MBBS MD (Pharmacology)Dr. VT.Sriraam MBBS MD (Pharmacology) Managing Director | Medical DirectorManaging Director | Medical Director
Aurous HealthCare CROAurous HealthCare CRO
Inside…Inside… BA BA -- BE Clinical Trials..BE Clinical Trials.. ..................Page 4..................Page 4
Schedules in D&C Act..........Schedules in D&C Act.......... ............Page 5............Page 5
Intent to Treat Analysis in Trials....Intent to Treat Analysis in Trials....Page 6Page 6
How do companies benefit from investing How do companies benefit from investing
in Clinical Trials???.......................in Clinical Trials???.......................Page 7Page 7
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Send a test mail and receive quarterly Send a test mail and receive quarterly
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Drugs and Cosmetics ActDrugs and Cosmetics Act
The Drugs and Cosmetics Act, 1940 is an Act
of the Parliament of India which regulates
the import, manufacture and distribution of
drugs in India. The primary objective of the
act is to ensure that the drugs and cosmetics
sold in India are safe, effective and conform
to state quality standards.
This act was originally known as the Drug
Act and was passed in 1940. The original act
was prepared in accordance to the
recommendations of the Chopra Committee
formed in 1930. The related Drugs Rules was passed in 1945. Since
1940, the act has undergone several amendments and is now known
as the Drugs and Cosmetics Act, 1940
Amendments in Drugs and Cosmetics Act that impact clinical
research (As amended up to 2016)
An Act to regulate the import, manufacture, distribution and sale
of drugs, Cosmetics and medical devices, to ensure their safety,
efficacy, quality and conduct of clinical trials and for matters
connected therewith or incidental thereto”
Definitions such as Ayurvedic, Siddha or Unani drug,
bioavailability study, bioequivalence study, Board, Central Drugs
Laboratory, Central Licensing Authority, clinical trial in respec-
tive drugs, cosmetics, medical devices etc.
No clinical trial is to be conducted without taking permission
from Central Licensing Authority in such form and manner as
may be prescribed.
Whether the injury or death of a person in the
course of a clinical trial, has been caused due to such clinical
trial or not, shall be determined by such authority and in such
manner as may be prescribed
Where a participant is injured or disabled in a clinical trial, the
person or body permitted under section 4A and the sponsor shall
provide such medical treatment and compensation in such man-
ner as may be prescribed
Where death of a participant is caused due to the
clinical trial, the person or a body permitted under section 4A
and the sponsor shall provide to his legal heir, such compensa-
tion ,in such manner as may be prescribed.
The Drugs Control Officer or any other officer authorised by the
Central Licensing Authority shall have the power to enter with or
without prior notice into any premises related to clinical trial to
inspect the facilities, record, data, documents, books, drugs in-
cluding investigational new drugs, notified category of medical
devices and cosmetics.
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ASSESSING BIOEQUIVALASSESSING BIOEQUIVALENCE & BIOAVAILABILITY OF GENERIC DRUGS ENCE & BIOAVAILABILITY OF GENERIC DRUGS ……
Bioavailability studies are intended to measure the rate and extent
to which an active drug ingredient or therapeutic moiety is absorbed
from a drug product and becomes available at the site of action.
Bioavailability is usually assessed by determining the area under the
plasma concentration–time curve or total amount excreted in the urine
after drug administration.
AUC is directly proportional to the total amount of unchanged drug that
reaches systemic circulation. Drug products are generally considered
bioequivalent in extent and rate of absorption if their plasma concentra-
tion curves are essentially super imposable.
Plasma drug concentration increases with extent of absorption and the maximum (peak) plasma concentration is reached
when drug elimination rate equals absorption rate. Bioavailability determinations based on the peak plasma concentration
can be misleading because drug elimination begins as soon as the drug enters the bloodstream. Peak time is the most widely
used general index of absorption rate; slower the absorption, later the peak time.
AUC is inversely proportional to the clearance of the drug. That is, the higher the clearance, the less time the drug spends in
the systemic circulation and the faster the decline in the plasma drug concentration. Therefore, in such situations, the body
exposure to the drug and the area under the concentration-time curve are smaller.
For drugs excreted primarily unchanged in urine, bioavailability can be estimated by measuring the total amount of drug
excreted after a single dose.
Ideally, urine is collected over a period of 7 to 10 elimination half-lives for complete urinary recovery of the absorbed drug.
After multiple dosing, bioavailability may be estimated by measuring unchanged drug recovered from urine over a 24-h pe-
riod under steady-state conditions.
Bioequivalence Studies
If two medicines are bioequivalent there is no clinically
significant difference in their bioavailability. Although
bioequivalence is most commonly discussed in relation to
generic medicines, it is important to note that
bioequivalence studies are also performed for innovator medi-
cines in some situations such as:
Between early and late clinical trial formulations or
between the formulations used in clinical trials and the product
to be marketed for new medicines.
When changes in formulation have occurred after an
innovator product has been approved, for example a change in one or more excipients (inactive ingredients).
Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. It is
measured by comparing the ratio of the pharmacokinetic variables for the innovator versus the generic medicine.
The acceptance criteria are such that to be classified as bioequivalent, plasma concentrations of the generic medicine will
not differ significantly compared with the innovator medicine.
Studies have demonstrated that actual differences between observed mean plasma concentrations of generic and innovator
medicines were no greater than 5%.
In order to determine that two medicines are bioequivalent there must be no more than a 20% difference between the
AUC and C max. This is based on international consensus that differences less than this are not clinically significant. In order
to establish this, the AUC and C max for the generic medicine are compared to that for the innovator medicine.
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SCHEDULES IN DRUGS ASCHEDULES IN DRUGS AND COSMETICS ACT...ND COSMETICS ACT...
Schedule A: Forms and applications
Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories
Schedule C: Biological and Special Products
Schedule C(1): Other Special Products
Schedule D: Class of Drugs: Extent and conditions of exemption
Schedule E: Omitted
Schedule E(1): List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine
Schedule F: Omitted
Schedule F(II): Standards for Surgical Dressings
Schedule F(III): Standards for umbilical Tapes Schedule FF: Standards for Ophthalmic Preparations
Schedule H: Prescription Drugs
Schedule I: Omitted
Schedule J: Disease and ailment (by whatever name described ) which a drug not purport to prevent or cure.
Schedule K: Class of drug: Extent and conditions of exemption
Schedule L1 : Good Laboratory Practice
Schedule M: Good manufacturing practices and requirements of premises, plant and equipment for Pharmaceutica
Schedule M-I:
1. Requirements of factory premises for manufacture of homoeopathic preparations.
2. Requirements of plants and equipments.
Schedule M-II: Requirements of factory premises for manufacture of cosmetic.
Schedule M-III: Requirements of factory premises for manufacture of medical devices.
Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy
Schedule O: Standard for Disinfectant Fluids
Schedule P: Life Period of Drugs
Schedule P1 : Pack Sizes of Drugs
Schedule Q: List of Dyes, colours and Pigments permitted to be used in Cosmetics and Soaps as given under IS : 470 BIS
Schedule R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives
Schedule S: Standard for cosmetics.
Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.
Schedule U:
I – Particulars to be shown in the manufacturing records.
II – Records of Raw Materials.
III – Particulars to be recorded in the analytical records.
Schedule U(I):
I – Particulars to be shown in manufacturing records.
II – Records of Raw Material.
Schedule V: Standards for patent or proprietary medicines.
Schedule W: Omitted
Schedule X: Narcotic Drugs & Psychotropic Substances
Schedule Y: Requirements and guidelines for permission to import and/or manufacture New Chemical
Entities (the schedule that gives you complete information regarding guidelines and processes for Clini-
cal Trials and Functioning of Ethics Committees.
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INTENT TO TREAT ANALINTENT TO TREAT ANALYSIS IN CLINICAL TRIALS ...YSIS IN CLINICAL TRIALS ...
Determining the sample of participants to
be analysed is a crucial step in reporting
clinical trials. For such analyses, the gold
standard is the “intention-to-treat”
principle.
Intention-to-treat analysis is a comparison
of the treatment groups that includes all
patients as originally allocated after
randomization. This is the recommended
method in superiority trials to avoid any
bias.
Advantages:
Retains balance in prognostic factors arising from the original random treatment allocation
Gives an unbiased estimate of treatment effect
Admits non-compliance and protocol deviations, thus reflecting a real clinical situation Requirements for an ideal ITT analysis
Full compliance with randomised treatment
No missing responses
Follow-up on all participants Limitations
Estimate of treatment effect is generally conservative because of dilution due to non-compliance
In equivalence trials (attempting to prove that two treatments do not differ by more than a certain amount), this analysis will favour equality of treatments
Interpretation becomes difficult if a large proportion of participants cross over to opposite treatment arms
Full application of intention to treat is possible only when complete outcome data are available for all randomised subjects
Application of ITT Analysis in clinical trials:
About half of all published reports of randomised controlled trials stated that intention to treat was used, but handling of deviations from randomised allocation varied widely.
Many trials had some missing data on the primary outcome variable, and methods used to deal with this were generally inadequate, potentially leading to bias.
Intention to treat analyses are often inadequately described and inadequately applied.
Universal Ethics Committee: Universal Ethics Committee: The Ethics Committee Division of The Ethics Committee Division of Aurous HealthCare Aurous HealthCare -- CRO…CRO…
Universal Ethics Committee (UEC), is a unit of Aurous HealthCare (CRO) that is registered
with CDSCO-DCGI holding registration number ECR/125/Indt/TN/2013 ECR/125/Indt/TN/2013 & OHRP (Office of
Human Rights Protection, Unites States) - IRB00008683. UEC has been serving the Clinical
Research fraternity since 2012 by providing guidance for conduct and ethical clearance for clinical
trial projects. Equipped with a GCP and Schedule Y compliant Expert member team, UEC contributes to the conduct of
justified human (clinical) trials. We also review and approve Post Marketing Surveillance studies...We also review and approve Post Marketing Surveillance studies...
Contact : [email protected]; [email protected]; or via +91Contact : [email protected]; [email protected]; or via +91--98409091559840909155
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HOW DO COMPANIES BENHOW DO COMPANIES BENEFIT FROM DOING CLINICAL TRIALS ???EFIT FROM DOING CLINICAL TRIALS ???
AUROUS HEALTHCARE RESEARCH AND DEVELOPMENT INDIA PRIVATE LIMITED
(Formerly Auroville HealthCare R & D India Pvt Ltd.)
#180/109, G1&G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai-600024.
Phone: +91-44 23720600, +91-44 32472446 • Mobile: +91 9840909155 Fax: +91-4423720600
[email protected] [email protected] [email protected]
www.auroushealthcare.com
THE PIONEER THE PIONEER CONTRACT RESEARCH ORCONTRACT RESEARCH ORGANISATION (CRO) GANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCHWITH FOCUS ON CLINICAL RESEARCH
www. auroushealthcare . wordpress auroushealthcare . wordpress .com The Quarterly Newsletter from AHC The Quarterly Newsletter from AHC -- CROCRO
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