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Clinical Research ::
This department focuses on clinical pharmacokinetics,
Phase I and Phase II clinical trials on Investigational
New Drugs - INDs, Phase III and IV clinical studies,
bio-equivalence studies for generic drugs.
The Unit has two independent functions
namely :
- Planning & execution of Phase-I, II,
III & IV studies,
- Clinical pharmacokinetic studies.
Major Functions :
Marketing of a new drug in India, requires a
Clinical trial in an appropriate patients population
to establish safety & efficacy and Bio-equivalence
study; comparing the bio-availability of test
formulation with reference i.e. innovator's formulation
in healthy volunteers.
The unit identifies unmet medical needs and
strives to find out a suitable intervention; be
it a drug formulation or a device. Presently,
regulatory activities for filing for domestic
market dominate majority of the work. This comprises
of Phase III & Phase IV Clinical trials. In
the changing global scenario and in conformation
with the goals of TRC, the unit contributes in
a multidisciplinary team for drug discovery. Investigators
Brochure and trial protocol as per ICH guidelines,
are prepared for clinical trials to be carried
out in India or internationally. Clinical Research
being the last portal for a drug going to the
regulatory authorities and ultimately to the market,
reviews all the evidences for its safety and efficacy,
before submission.
The unit liaises with regulatory authorities
i.e. Drugs Controller General (India) for necessary
test license and permissions for carrying out
clinical trial and for obtaining manufacturing
& marketing permission for a new drug.
The unit has requisite capabilities to plan
for, conduct of and analyzing the results of the
clinical studies carried out in collaboration
with various prestigious Medical Institutes all
over India.
With a view to keep in touch with the medical
professionals for unmet medical needs, the Unit
also liaises with eminent professionals in the
TRC's present thrust areas i.e. Diabetes, Coronary
Artery Disease, Tuberculosis and Organ Salvage
after Ischaemic Damage.
New Products Selection & Development
in :
- Liaison with Marketing Division
- Liaison internally with R&D Divisions
- Liaison with Collaborators
Studies :
- Phase I, II, III & Phase IV Clinical
Trials
Regulatory Affairs :
- Pre-Marketing / Marketing / Post Marketing
Training / Promotional Activities :
- Field Staff Training / Clinical Symposia
/ Work Shop / Panel Discussions
Achievements :
As a part of Domestic / International Regulatory
requirements, Clinical Research has conducted
clinical trials of several molecules including
Nocorandil, Repaglinide, Rosiglitazone, Clopidogrel
& Sildenafil in the recent past.
The following are some of the recent
introductions :
- Alprazolam SR
- Carvedilol
- Cerivastatin
- Cetirizine
- Clopidogrel
- Fexofenadine
- Fluconazole eye drops
- Ketoconazole Shampoo
- Lactacyd
- Lamotrigine
- Lisinopril + Hydrochlorothiazide low
dose combination
- Losartan
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- Lovastatin
- Mosapride
- Moxifloxacin
- Nicorandil
- Omeprazole
- Repaglinide
- Risperidone
- Rosiglitazone
- Serenova Repens
- Sibutramine
- Sildenafil
- Sparfloxacin
- Venlafaxine
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Clinical Pharmacokinetics :
One of the critical aspects in the process of
a "chemical" becoming a "drug"
is thorough understanding its kinetics i.e. the
processes it passes through once administered
in the body until the time it is excreted out.
It is thus, study of absorption, distribution,
metabolism and excretion of a drug.
Major inputs for this come from animal kinetics
studies carried out during the pre-clinical development.
The process of planning for pharmacokinetics
studies for New Chemical Entities (NCE) starts
with identification of lead compound. Pharmacological
/ Toxicological evaluations have built in parameters
for study of animal pharmacokinetics. This help
in finalizing the dose range for Phase-I studies.
Thus, the actual studies start much later in the
process of drug development, the data generated
all through help in defining the kinetic parameters
the formulation must achieve.
Clinical Pharmacokinetics carries out human pharmacokinetic
studies on generic drugs in conformity with GCP/GLP
guidelines, both for domestic as well as international
regulatory requirements. Apart from requirements
of regulatory submission, kinetic studies in smaller
number of volunteers, is carried out as an on
going activity for confirming the bio-availability
of a new formulation.
Major functions :
The unit has two distinct functions viz.:
- Comparative Bio-availability Studies for
Known Molecular Entities
- Bio-availability Studies for New Chemical
Entities (NCE)

Achievements :
Since the time of its inception, the unit has
conducted 38 (12 / 24 volunteers) pharmacokinetic
studies. In these studies, a comparative bioavailability
of Torrent's formulation (Test) was measured against
Innovator's brand (Reference). These studies have
been used for domestic as well as international
regulatory submissions.
Test Formulation (Torrent) :
- Amlodipine (AMLOC)
- Amoxicillin (TORMOXIN)
- Ampicillin (TORCILLIN)
- Azithromycin (AZITOR)
- Carbamazepine SR (CARBATOL SR)
- Carteolol
- Cefadroxyl Disp (250mg x 2) (DROXYL KID)
- Cefixime (TOPCEF)
- Cerivastatin (SERIVA)
- Cetirizine (ZIRTIN)
- Ciprofloxacin (QUINTOR)
- Cisapride (UNIPRIDE)
- Clopidogrel (DEPLATT)
- Diclofenac Potassium
- Diltiazem USP (DELTAZEM 60)
- Fexofenadine (FEXO 120 - 180)
- Finasteride
- Lamotrigine (LAMITOR)
- Lansoprazole (LANSOTOR)
- Losartan (TOZAAR)
- Mefloquine
- Mosapride (MOSID MT 2.5 & 5)
- Moxifloxacin (MOXIF 400)
- Nicorandil (NIKORAN)
- Nimodipine (NIMOTIDE)
- Pefloxacin (PEFCIN)
- Repaglinide (EUREPA)
- Risperidone (RESPIDON)
- Rosiglitazone (ENSELIN)
- Sertraline (SERENATA)
- Sibutramine (SLENFIG)
- Sildenafil (ANDROZ)
- Sodium Valproate + Valp. Acid (VALPARIN SR)
- Sparfloxacin (TOROSPAR)
- Sultamicillin (BETAMPORAL)
- Venlafaxine (VENLIFT)
- Zolpidem
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