Bioequivalence Study Centre

The B.E. Centre had been carrying out Bioequivalence study most satisfactorily since 2002 being approved by DCGI Oct-2002.

BIOAVAILABILITY AND BIOEQUIVALENCE STUDY

The B. E. Centre had been carrying out Bioequivalence study most satisfactorily since 2002 being approved by DCGI letter No.4-I 4/97 pt (I) dt. 21 Oct 2002.

The only Bioequivalence Centre in the Eastern region of India under Jadavpur University is having the requisite facilities as well as the state-of-the art instrumental support. There are provisions to accommodate 24 healthy human volunteers at a time in the cozy air-conditioned CPU (Clinical Pharmacology Unit).

Prior to the undertaking of B.E.Studies all the protocols are approved by institutional Ethical Committee (IEC) of Jadavpur University constituted as per guidelines of ICMR. The B.E.Study is carried out under the guidance of clinical pharmacologist, medical officer, nurse and medical laboratory technicians where the analysis of blood plasma concentration of drug by HPLC is being carried out by experienced Scientists at the sophisticated analytical laboratory under J.U.

Name of The Drugs Analysed Till Now

Name of Drugs

Tamsulosin & Dutasteride

Pregabalin,

Ethinyl Estradiol & Drospirenone,

Ranolazine,

Levoceterizine hydrochloride 5mg ,

Tacrolimus,

Artemether & Lumefantrine,

Atorvastatin 20mg + Ezetimibe 1O mg (FDC),

Levonorgestrel 0.75mg ,

Active Metabolite of Deflazacort,

Name of Drugs

Metoprolol Succinate 100 mg,

Carbamazepine 400mg,

Rabeprazole Sodium 20mg,

Linezolid Rabeprazole Sodium 20mg,

Aceclofenac 100mg,

Escitalopram Oxalate 20 mg,

Levetiracetam,

Valdecoxib 20 mg ,

Sodium Valproate & Valproic acid 500 mg,

SR Atorvastatin 10mg

Development of Pharmaceutical Formulation

We undertake jobs in development and up-gradation of formulation specially in the field of sustained
release drug delivery system. The on-going projects on the development of matrix tablet (S.R.) are
illustrated below :

Name of the Company : Stadmed Pvt. Ltd., Kolkata , A.N.Pharmacia Pvt. Ltd., Kolkata

Product : Pseudoephidrine + Loratidine SR , Divaloporex SR Tablets

Toxicity Study

We undertake the jobs on Subchronic Toxicity Study on mice and rats (28days). The Department is having the state-of-the art air-conditioned animal house to accommodate at least 300 animals. Modern facilities, quality control and quality assurance are maintained by the in- house experts where the haematological and pathological data are evaluated in our own pathological laboratory. The compilation of clinical data is carried out by the guidance of experienced clinical pharmacologist.
Some of ongoing / completed projects are listed below:

Name of the Company : GAURAV PHARMACEUTICAL PVT. LTD New Delhi , ARCHERCHEM MUMBAI , RAKSHIT DRUGS PVT. LTD. HYDERABAD , ALMELO CHEMICALS PVT. LTD. HYDERABAD , MSN LABORTRIES LTD. HYDERABAD

Name of the Drugs : GATIFLOXACIN , MECOBALAMIN , MIFEPRISTONE , DIACEREIN ,
FEMCICLOVIR , TADALAFIL , BALSALAZIDE , VALDECOXIB , VORICONAZOLE, ROFLUMILAST,
EPLERENONE , LACIDIPINE.

Clinical Trial

The Centre has got the expertise to undertake Second phase multicentric Clinical trial on patients in
collaboration with International Medical Research Organization, Saltlake Kolkata.

PROJECT IN THE PIPELINE

Name of the Company : EMAMI LIMITED, KOLKATA.

Drugs : A LOTION CONTAINING LOW MOLECULAR WEIGHT PEPTIDES