Pharmacokinetician

PUNNAMCHAND LOYA M.Pharm Sci., Ph.D. (T)

Mobile: +91-966*******; E-Mail: ~ ******@*****.***

To achieve professional excellence through continuous learning and utilize my skills & experience in the growth of the organization

To complete any project undertaken with responsibility and honesty and excel in the field of pharmaceutical research & development as clinical pharmacologist through good analytical & visionary skills.

PROFESSIONAL SUMMARY

• A Study Co-ordinator (PhD in Pharmacology) with more than 1.0 years of experience in the pharmaceutical industry.

• Demonstrated ability to attain and maintain a working knowledge of ICH-GCP, schedule Y (Indian CDSCO guidelines), eCTD, and applicable SOPs and relevant guidelines.

• Expertise in BA/BE studies and Phase- III clinical research studies, managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.

• Comprehensive understanding of Clinical Research Practices, applicable standards viz., GCP guidelines, local and International regulations.

• Good knowledge of regulatory guidelines and submission requirements for BA/BE and clinical studies.

EDUCATIONAL QUALIFICATION

• Ph.D. (Tech) in Feb 2012 from Bombay College of Pharmacy, University of Mumbai, Mumbai, India.

• Master’s Degree in Pharmacy (M.Pharm, Secured first class (57.4%)) in 2003 from Prin. K. M. Kundnani College of Pharmacy, University of Mumbai, Mumbai, India.

• Qualified in Graduate Aptitude Test in Engineering (GATE-1999), conducted by IIT, with 87.78 percentile marks.

• Bachelor’s Degree in Pharmacy (B.Pharm, Secured first class (62%)) in 1998 from St. John’s Pharmacy College of Pharmacy, Bangalore University, Bangalore, India.

Ph.D. (Tech) DETAILS

Thesis title : Studies on Determination of Bioactive Compounds in Biological Fluid

Research Guide : Dr. M. N. Saraf

Major : Pharmacology

Brief Description of the Ph.D. Thesis Project:

A Simple non invasive Pharmacodynamic model i.e. inhibition of methyl nicotinate induced inflammation by dexibuprofen Using Laser Doppler Flowmeter was standardised in Indian Healthy male volunteers and applied for the concentration- time study following single oral dose of 400 mg dexibuprofen tablets Indian healthy male volunteers. A pharmacokinetic study was conducted for 400 mg dexibuprofen tablets in Indian healthy male volunteers. A simple linear PK-PD model was developed for the single dose 400mg dexibuprofen tablets in Indian healthy male volunteers.

A PK-PD comparison of metformin in Indian Healthy male volunteers were done by measuring the blood glucose levels after administering a single dose of 500 mg metformin hydrochloride tablets along with the sugar and food using glucometer.

A new, rapid, simple, sensitive, specific and less expensive assays were developed and validated for the estimation of actarit, amtolmetin and its metabolites and loxoprofen from human plasma and were successfully applied for the analysis of plasma samples obtained from the bioequivalence study conducted in healthy male volunteers.

M.Pharm DETAILS

Thesis title : Determination of Oral Antibacterials and/or Other Drugs in the Biological Fluid

Research Guide : Dr. (Mrs.) P. D. Hamrapurkar

Major : Pharmaceutical Analysis

Brief Description of the M.Pharm Thesis Project:

Developed a new method for the estimation of clarithromycin from plasma on HPTLC and applied the developed method for the analysis of clinical plasma samples of clarithromycin.

Improved the sensitivity of the method for the estimation of Minocycline from Plasma.

ACADEMIC ACHIEVEMENTS

• Awarded Research Associate by Research Society Bombay College of Pharmacy, for the period of Jan 2006-Jan 2007

• Awarded Junior Research Fellowship by Amrut Modi Research Fund, for the period of Jan 2007-Mar 2009

• Fellowship for M. Pharm Course awarded by AICTE, India.

WORK EXPERIENCE

1. Name of the Organization : M.G.M Medical College

Designation : Pharmaceutical Chemist

Period : June 2008 to Dec 2009.

2. Name of the Organization : Dr. M.K .R. Rangnekar Drug Testing Laboratory

Designation : Research Associate

Period : Jan 2005 to Jan 2006.

3. Name of the Organization : The Bombay College of Pharmacy

Designation : Technical Assistant

Period : Sept 19, 2003 to Sept 18, 2004.

4. Name of the Organization : Noki Technologies Pvt. Ltd.

Designation : Application Specialist

Period : April 11, 2003 to Sept 19, 2003.

5. Name of the Organization : PHOENIX BIOPHARMA RESEARCH CENTRE (PBRC)

(A Division of ALKEM Laboratories)

Designation : Pharmaceutical Analyst.

Period : Mar 23, 2002 to Apr 7, 2003.

PROFESSIONAL CAPABILITIES

• Involved in and well acquainted with conducting of BA/BE trials starting from protocol designing, ethics committee approval, volunteer selection (including taking written Informed Consent Forms), coordinating with the volunteers, all the study personnel’s and sponsors and filling of case record forms, report writing.

• Member Coordinator of the Institutional Ethics Committee of Bombay College of Pharmacy.

• Conversant in handling sophisticated instruments like HPTLC, HPLC, GC, SFC/SFE, DSC, UV-Spectrophotometer, FTIR, Electro chemical detector etc.

• Expertise in analytical method development of drugs in biological fluid (Bioequivalence Studies) with good documentation skills as per GLP.

• Validation of analytical methods for plasma samples as per guidelines.

• Dissolution Method Development for the Pharmaceutical dosage forms.

PROJECTS HANDLED

• Bioequivalence Studies of Various Drugs at KMKCP, PBRC and BCP.

• Developed Analytical methods for various Drugs for their determination from plasma samples (Bioequivalence studies) at KMKCP, PBRC & BCP.

• Developed a Pharmacokinetic-Pharmacodynamic Modelling in Improving Antimicrobial Therapy- AICTE Sponsored Project

• Comparative Evaluation of Topical Formulations for Onset and Duration of Action on Healthy Human Volunteers using Laser Doppler Flowmetry.

• Forced Degradation Study of Atenolol at MKR labs

• Residual Solvents determination of Various Drugs by HS-GC at MKR labs.

• Quality Control Test (Analytical Methods Developed and Validation-Including Stability Indicating Assays) for the Drugs like Simvastatin, Lovastatin, Fluoxetine and Related Compounds etc- at MKR labs.

TECHNICAL EXPERTISE

Handling of analytical tools likes:

• Jasco V530 UV-Vis spectrophotometer,

• HPLC- JASCO, Agilent, Waters, Shimdzu

• CAMAG HPTLC with Densitometric Scanner

• Head Space GC-Aster

• FTIR-JASCO

PUBLICATIONS

• Punnamchand Loya & Madhusudan N. Saraf. A Simple HPLC-UV Method Development and Validation for the Quantification of Dexibuprofen Applied in Bioequivalence Study. Journal of Liquid Chromatography & Related Techniques (In Press).

• Punnamchand Loya, Ashish A. Kshatriya & Madhusudan N. Saraf. Bioequivalence Study of Two Brands of Loxoprofen Tablets in Healthy Volunteers. Int. J. PharmTech Res. 2011, 3(4), 2038-46.

• Punnamchand Loya & Poornima D. Hamrapurkar. A Simple, Rapid and Sensitive HPTLC Method for the Estimation of Clarithromycin: Application to Single Dose Clinical Study. Journal of Planar Chromatography. 24 (2011) 6, 534-538.

• P. Loya and M. N. Saraf. Determination of Actarit from Human Plasma for Bioequivalence Studies. Indian Journal of Pharmaceutical Sciences. 72 Nov-Dec (2010): 726-31.

• Punnamchand Loya and Madhusudan N. Saraf. Determination of Amtolmetin and Its Active Metabolites in Plasma by HPLC-UV: Application to a Bioequivalence Study. J Bioequiv Availab. 2(2) 2010: 37-44.

• Khan I J, Loya P & Saraf M N. A Simplified HPLC Method for Quantification of Torsemide from Human Plasma and its Application to Bioequivalence Study. Indian Journal of Pharmaceutical Sciences. 70 Jul-Aug (2008): 519-22.

• Madhusudan N. Saraf, Pramod G. Birajdar, Punnamchand Loya & Siddharth A. Mukherjee. Rapid & Sensitive HPTLC Method for the Determination of Epalrestat in Human Plasma. Journal of Planar Chromatography. 20(3) 2007: 203-7.

• Khan I J, Loya P & Saraf M N. A Simple Sample Preparation with HPLC-UV Method for the Estimation of Tiropramide from Plasma: Application to Bioequivalence Study. Journal of Pharmaceutical and Biomedical Analysis. 43 (2007): 1135-40.

• Manglani U R, Khan I J, Soni K, Loya P & Saraf M N. Development and Validation of HPLC-UV Method for the Estimation of Rebamipide in Human Plasma. Indian Journal of Pharmaceutical Sciences. 68 Jul-Aug (2006): 475-8.

• Trivedi C, Soni K, Khan I J, Loya P, Umesh M. and Saraf M N. High-Performance Liquid Chromatographic Analysis with Ultraviolet Detection for the Determination of Domperidone in Human Plasma. Indian Drugs. 42(7) 2005: 461-4.

PRESENTATIONS

• P Loya*, A A Kshatriya and M N Saraf. Bioequivalence study of two Brands of Loxoprofen Tablet in Healthy Volunteers. Poster presentation at International conference and Exhibition Bioequivalence and Bioavailability 2010 Pharmaceutical R & D summit at Hyderabad, India by Omics Publishing group USA.

• P Loya P, A A Kshatriya* and M N Saraf. Correlation of Plasma Levels (PK) with the Inhibition of Methyl Nicotinate Induced Erythema (PD) of Dexibuprofen in Healthy Human Volunteers. Poster presentation at International conference and Exhibition Bioequivalence and Bioavailability 2010 Pharmaceutical R & D summit at Hyderabad, India by Omics Publishing group USA.

• Loya P, Shirole R L* and Saraf M N. Pharmacokinetic and Pharmacodynamic Integration of Dexibuprofen Tablet in Healthy Human Volunteers. Oral and Poster Presented at Avishkar - Interuniversity State Level Research Festival-2010 at Solapur.

• Khan I J, Loya P* & Saraf M N. RP-HPLC Method Development and Validation for Determination of Tenatoprazole: Novel Proton Pump Inhibitor. Oral Presentation at 58th Indian Pharmaceutical Congress, Mumbai, Dec 2006.

• Khan I J, Loya. P* & Saraf M N. A Simplified HPLC Method for Quantification of Torsemide from Human Plasma and its Application to Bioequivalence Study. Oral Presentation at 58th Indian Pharmaceutical Congress, Mumbai, Dec 2006.

• Loya P*, Birajdar P G & Saraf M N. A Validated RP-HPLC Method for the Determination of Ranolazine in Human Plasma. Oral Presentation at 57th Indian Pharmaceutical Congress, Hyderabad, Dec 2005.

• Mukherjee S A, Loya P, Birajdar P G & Saraf M N. Rapid & Sensitive Method for the Determination of Epalrestat in Human Plasma by HPTLC. Oral Presentation at 57th Indian Pharmaceutical Congress, Hyderabad, Dec 2005.

• Khan G J, Khan I J, Trivedi C A, Soni K, Loya P, Birajdar P G, Patel M A & Saraf M N. Reverse Phase HPLC Method for Estimation of Moxifloxacin in Human Plasma and Its Application to Pharmacokinetic Analysis. Poster Presentation at 56th Indian Pharmaceutical Congress, Kolkatta, Dec 2004.

• Khan G J, Khan I J, Trivedi C A, Soni K, Loya P, Birajdar P G, Patel M A & Saraf M N. A Validated RP HPLC with Florescence Detection for Estimation of Levofloxacin in Human Plasma. Poster Presentation at 56th Indian Pharmaceutical Congress, Kolkatta, Dec 2004.

• Khan G J, Khan I J, Trivedi C A, Soni K, Loya P, Birajdar P G, Patel M A & Saraf M N. HPLC Method Development and Validation of Paroxetine Tablets for Bioequivalence Studies in Healthy Subjects. Poster Presentation at 56th Indian Pharmaceutical Congress, Kolkatta, Dec 2004.

• Manglani U, Khan I J, Trivedi C A, Soni K, Loya P, Birajdar P G, Patel M A & Saraf M N. Evaluation of Pharmacokinetic Parameters for Bioequivalence of Rifabutin Tablets in Healthy Subjects. Poster Presentation at 56th Indian Pharmaceutical Congress, Kolkatta, Dec 2004.

• Lalla J K, Hamrapurkar P D, Loya P*, Anuradha R & Shah M U. Comparison of HPLC with HPTLC for Clarithromycin Estimation from Plasma. Oral Presentation at 52nd Indian Pharmaceutical Congress, Hyderabad, Dec 2000.

• Lalla J K, Hamrapurkar P D, Patil P S, Loya P & Shah M U. Biokinetics of the Venlaflaxine in Human Plasma. Poster Presentation at 52nd Indian Pharmaceutical Congress, Hyderabad, Dec 2000.

TRAINING PROGRAMMES ATTENDED

• One month training in the area of production i.e. manufacturing, Finishing, Stores & Quality Control at SmithKline Beecham, Bangalore (Apr 1999, as B.Pharm Curriculum)

• One day training programme on the “Independent Ethics Committee and Sponsor’s Responsibilities” conducted by Academy for Clinical Excellence on Jan 17, 2003 at The Bombay College of Pharmacy, Mumbai.

• Two day training programme on the “Compliance in New and Generic Clinical Drug Development” conducted by Transworld Institute of professional & Training and Indian Pharmaceutical Association on July 28 & 29, 2006, at Hyderabad.

• One day national seminar on the “Drug Discovery & Development” conducted by University of Mumbai (Sesquicentennial Celebrations) & Bombay College of Pharmacy on Nov 7, 2006 at The Bombay College of Pharmacy, Mumbai.

DOCUMENTATION EXPERTISE

• Well acquainted with the preparation of standard operating procedure required for the clinical as well as analytical sections of the Clinical Research Center.

• Documents required for conducting bioequivalence trial such as Protocol, CRF and ICF.

• Report writing for the bioequivalence study.

COMPUTER PROFICIENCY

• Competent with Computer programs like MS Office and Acrobat professional

• Well versed with Operating Systems like Windows 7, Vista and Windows XP

PERSONAL DETAILS

Contact Address : C/o Narayanprasad Loya, 21-3-727/2, SAKET, Govindwadi, Chelapura, Hyderabad-500 002, INDIA.

Date of Birth : Nov 6, 1976

I hereby declare that the information given above is true to the best of my knowledge and belief.

Punnamchand Loya

M.Pharm Sci., Ph.D. (T)

REFERENCES

Dr. M.N. Saraf

Principal & Prof in Pharmacology

Bombay College of Pharmacy

Kalina, Santacruz (E)

Mumbai-400 098, INDIA.

Email: *****@***.***.**

**********.*****@*****.***

Contact: +91-22-266***** / 26671027 (Off)

+91-982******* (Mobile) Rao V. S. V. Vadlamudi, Ph.D.

Director-St. Peter's Institute of Pharmaceutical Sciences, Warangal,

Editor, Indian Journal of Pharmaceutical Sciences

Vora Towers, Madhuranagar, Yousufguda Road

Hyderabad-500 038, INDIA.

Email: *******@*****.**.**

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Contact: +91-40-668*-**** (Res)

+91-986******* (Mobile)

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