Chettinad Hospital and Research InstituteKelambakkam, Tamilnadu

Advanced Workshop onBioavailability / Bioequivalence (BA/BE) Studies

January 9 & 10, 2015

Organized by:

Department of Pharmacology

Chettinad Hospital and Research Institute

Chettinad Health City, Rajiv Gandhi Salai,

Kelambakkam, Kanchipuram Dist.

Tamil Nadu, India

Phone: 044 47429210 / 9211 / 9212

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Food preference: Veg / Non veg

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Address for Correspondence

Dr. A. Ruckmani/ Dr. R. Arun Kumar

Dept. of Pharmacology, Chettinad Hospital & Research Institute

Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Kanchipuram Dist-603103. Tamil Nadu, India

Email: babe2015.chettinad@gmail.com

Phone: 044 47429210 / 9211 / 9212

Chettinad Hospital and Research Institute, KelambakkamAdvanced Workshop on BA/BE Studies

January 9 & 10, 2015andand

Registration Fee: Rs 2000 before 20th Dec 2014 and Rs 2500 till 5th Jan 2015.

There is no spot registration.

Registration fee includes lunch and snacks for 2 days, course materials and cost for CRO visit.

Advanced Workshop onBioavailability / Bioequivalence Studies

BA/BE studies are mandatory for the marketing approval of generic drugs and carried out to

establish that the generic drug is bioequivalent to the reference drug. Commonly,

bioequivalence is ascertained by comparing statistically the pharmacokinetics of generic and

standard/ reference drug.

The objective of conducting this advanced workshop is to enable the participants acquire the

necessary skills to conduct a BA/BE study independently. These skills include designing

BA/BE studies, sample size calculation, sampling time, PK parameter calculation, software

applications, and some special issues involved with highly variable drugs (HVDs) and

endogenous molecules and others as given in the enclosed schedule which have been

included for the first time. Eminent persons from industry and academia will train the

participants in these areas.

This workshop is organized in collaboration with Azidus Laboratories, a leading CRO in

India, accredited by US-FDA, ANVISA- Brazil and other regulatory agencies.

Note:

• Number of registrations is restricted to 50 only.• Participants have to bring laptops for practical training.

• Participants will be taken to CRO to observe a BA/BE study on day 2.• Advised to start early to reach the venue on time. (The institute is 30-35km away from the city of Chennai).

• Participants are requested to make their own arrangements for transport & accommodation. However limited accommodation will be available at nominal cost on

campus with advanced intimation.

• Workshop will start at 9 AM on day 1 and 7.30 AM on day 2 for field visit.• For assistance, contact the organizing team at 044 47429210 / 9211/ 9212 and

9941176176, 9841827729.

Some of the nearby hotels:

1. Southern Residency,Contact No: +91 98848 44666/+91-44-47415000

2. Amity Hotel, Contact No: +(91) -44 - 66756607

3. Gem Inn Resort: +(91) -44 - - 4742 4242

4. Sabari Classic: +(91) -44 - 4744 5000

PROGRAM SCHEDULE: Day- 1 (09.01.2015)

PROGRAM SCHEDULE: Day- 2 (10.01.2015)

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Introduction to BA/BE studies

BE study designs

Special situations:

Highly variable Drugs (HVDs), Endogenous molecules, Narrow therapeutic drugs, Oncology & Psychiatry drugs, Hormonal agents

BE study conduct and analysis

Regulations

BA/BE study templates

Facility overview of CRO

Innovator and generic drugs, NDA and ANDA, What is BA and BE, Why and when BE, Types of BE, PK parameters, BE criteria

Pilot, Pivotal studies, study designs, wash out period, single and multiple dose studies, healthy volunteers or patients, Randomization and blinding in BE studies, fasting, fed and apple sauce studies, No. of subjects, calculation of sample size, schedule and duration of PK blood sampling, analyte for estimation, checklist for study design, challenges in designing the study

Inter and intra-subject variability, Highly variable drugs and Low variable drugs, Challenges in handling HVDs

Endogenous drugs (Vit A, D & K, Progesteron, Estrogen, Thyroxine), Design issues

Safety of study subjects - narrow therapeutic and cytotoxic drugs, modified BE criteria

Special population – Patients, females, pediatrics & geriatrics

Ethics, Clinical, Bioanalysis, PK-statistics, QA, Clinical issues in study conduct – influence of vomiting, diarrhea in drug absorption, sample spillage and AE/SAE.

� Protocol, ICF, CRF, study report, SOPs,

Software applications – WinNonlin, SAS, volunteer database

BE conclusion – ABE, RSABE, expandable limits

Schedule Y, GCP, Indian BA/BE guidance, 21 CFR 320and FDA guidance, BE recommendations for specific products, ANVISA, EMA, Other regulations, Para IV filing and 505b(2) filing for US, ICH E3 for reporting, CTD and eCTD formats

Protocol, CRF, ICF and translations, Study report

Departments of CRO, Floor plan, Administrative structure

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CRO visit

Hands on training

CRO Facility tour, Observation of study conduct – dosing, phlebotomy, sample processing, drug dispensing

Designing BE studies, Sample size calculation

Blood sampling schedule

PK calculations

BE establishment

Winnonlin and SAS (software)

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