Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB
`20 Riverside Drive, Deerfield, Illinois 60015. USA
`Phone: +1-312-298-0000; Fax: +1-312-297-1100; email: niazi@niazi.com
`
`Expertise:
`• Pharmaceutical
`Preformulation
`• Pharmaceutical Formulations
`• Commercial Manufacturing
`• Bioequivalence Testing
`
`• Biological Products
`Formulation
`• Clinical Testing
`• Statistical Modeling
`• Bioprocess Technology
`• New Chemical Entities
`
`Education:
`• 1974: Ph.D., Pharmaceutical Sciences, University of Illinois, Chicago, IL
`• 1970: MS, Pharmaceutical Sciences, Washington State University, Pullman, Washington
`• 1969: B. Pharm., Karachi University, Pakistan
`• 1968: Diploma Marketing, Institute of Business Administration, Karachi, Pakistan
`• 1966: BSc., Karachi University, Pakistan
`
`Professional:
`Patent Agent, US Patent and Trademark Office, 2002-present. Prosecuted 200+ patents.
`
`Positions:
`Academic:
`• 1972-1988: Instructor to Tenured Associate Professor at University of Illinois College
`of Pharmacy, Chicago, Illinois.
`• 2000-Present: Visiting and Foreign Professor, HEJ Research Institute, Karachi,
`Pakistan.
`• 2004-present: Visiting Professor, National University of Science and Technology,
`Islamabad, Pakistan.
`• 2012-Present: Visiting Professor, University of Houston College of Pharmacy.
`• 2015-Present: Adjunct Professor of Biopharmaceutical Sciences, University of
`Illinois College of Pharmacy
`Corporate:
`• 1988-1995: Director Technical Affairs, Abbott International.
`• 1995-Present: Founder and Executive Chairman, Pharmaceutical Scientist, LLC,
`Chicago, IL.
`• 2003-2017: Founder and Executive Chairman, Adello Biologics, LLC (formerly
`Therapeutic Proteins Inc.), the first and fully integrated biosimilar products company
`in US, now owned by Kashiv Biosciences.
`
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`• 2017-present: Founder and Executive Chairman, Karyo Biologics, LLC, a virtual
`biosimilar products development company with several products in clinical approval
`stage with FDA.
`Professional
`• 2002-present: United States Patent and Trademark Office, Patent Agent.
`
`Recognitions, Awards, and Contributions
`• Civil Award by the President of Pakistan (Sitara-e-Imtiaz) for contribution to
`biotechnology.
`• Fellowship of Royal Society of Biology, Pakistan Academy of Medical Sciences,
`American Society of Clinical Biochemistry.
`• Forbes Magazine’s Cover Pages:
`• “The Most Interesting Man Revolutionizing The Health World” 2014
`• “Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is
`Listening.” 2019
`•
`Invited contributor to BPCIA as advisor to the US Congress
`•
`Invited advisor to President Obama.
`• Advisor to US FDA on Biosimilars Guidance and Bioequivalence Testing
`• Volwiler Fellow Abbott Laboratories (tenured)
`• US Pharmacopoeia: advisor on Biosimilar Monographs, teaching faculty
`•
`Inductee as US Entrepreneur Hall of Fame.
`• University of Illinois Alumni of the Year
`• TOKTEN Fellow for US Aid under PL-480 program.
`• March of Dimes grant reviewer.
`• Editorial boards of scientific journals.
`• Radio host for Voice of America since 2008.
`• Advisor to Higher Education Commission of Pakistan on intellectual property
`management since 2012
`• Pro bono service to scientist in the developing countries to secure US patents.
`•
`Invited speaker 500+ engagements worldwide.
`•
`Innovation of the Year, Sponsored by Honeywell; Global Generics and Biosimilars
`Awards 2014: https://www.generics-bulletin.com/media/19636/Winners-for-
`Website1.jpg
`• Finalists Best Upstream Technology Application 2012: TPI Single-use technology for
`production of bacterial proteins, Bioprocess International
`(http://www.bioprocessintl.com/bioprocess-international-2016-awards/past-winners-of-
`bioprocess-international-awards/).
`
`Achievements
`• Created the first line of generic products for Abbott Laboratories, solid dosage forms,
`suspensions, liquids.
`• Assisted 10+ companies worldwide to establish biosimilar development and
`manufacturing.
`
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`• Convinced FDA to withdraw its Biosimilars Statistical Modeling Guidance and suggested
`replacement with a rational approach (August 2018).
`• Convinced FDA to declare that comparative clinical efficacy trials are not appropriate
`(May 20190.
`• Trained new hires as FDA inspectors in cGMP compliance.
`• Trained 46 graduate students: MS. Ph.D.
`• 100+ US patents; largest solo inventor of bioprocessing patents; NCE, NBE, drug
`delivery, natural products, drug testing, wine aging, automobile safety, disease
`management, and other technologies.
`• Developed a fourth-dimension analytical similarity testing to achieve fingerprint-like
`similarity for biosimilars.
`• Developed a biodistribution PK model recommended by FDA in 2019 to establish
`interchangeability (May 2019)
`• Developed an ISO 9 bioreactor used to file the first BLA of a biosimilar.
`• First handbook authored on biosimilars. Largest number of books on biosimilars.
`• First book on FDA views on biosimilarity; dedicated to Dr. Woodcock.
`• Coordinated dozens of FDA audits of generic and biological manufacturers, secured first
`FDA approval of a product from ME countries.
`• Advised dozens of regulatory authorities on creating guidelines: Indonesia, Canada,
`Japan, US and Australia.
`• Consultant to investment bankers, VC groups and private investors on value proposition
`analysis in the field of pharmaceutical and biopharmaceuticals.
`• Served as expert witness in IP and pharmaceutical cases.
`• Taught physicians in the US on the regulatory pathways and safety features of biosimilars
`on behalf of large pharma companies.
`• Founded the first US biosimilars company—raised $500 Million [largest funding of
`startup biotech in US history].
`• Chicago Marathon runner 2014.
`
`Press
`
`
`
`
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`
`• https://bioprocessintl.com/2019/january-february-2019/january-february-bioprocess-
`insider/
`• https://bioprocessintl.com/bioprocess-insider/global-markets/biosimilars-big-pharmas-
`imminent-exit-in-sight-says-expert/
`• https://bioprocessintl.com/2018/january-february-2018/january-february-editor/
`• https://bioprocessintl.com/wp-content/uploads/2015/06/13-6-SpRptSecured.pdf
`• https://bioprocessintl.com/wp-content/uploads/2015/05/13-5-Simon3-Secured.pdf
`• https://bioprocessintl.com/wp-
`content/uploads/2014/08/Process_Innovation_Biosimilars_TheraProteins.pdf
`• https://bioprocessintl.com/wp-
`content/uploads/2014/05/BPI_A_110909SUPAR03_167974a.pdf
`• http://www.bioprocessintl.com/wp-content/uploads/2014/05/0648su02_78490a.pdf
`• http://www.bioprocessintl.com/wp-content/uploads/2014/05/0648su02_78490a.pdf
`• https://www.centerforbiosimilars.com/news/citizen-petition-asks-fda-to-withdraw-
`contentious-biologic-naming-guidance
`• https://www.centerforbiosimilars.com/news/biosimilar-regulatory-roundup-march-2019
`• https://www.centerforbiosimilars.com/contributor/sarfaraz-niazi/2018/12/the-fda-
`biosimilar-action-plan-making-biologics-more-accessible
`• http://gabi-journal.net/rationalizing-fda-guidance-on-biosimilars-expediting-approvals-
`and-acceptance.html
`• https://www.forbes.com/sites/nicolefisher/2018/07/25/one-mans-mission-to-fix-the-fdas-
`biosimilar-problem/#1d8b19792380
`• https://www.forbes.com/sites/nicolefisher/2014/08/30/the-most-interesting-man-
`revolutionizing-the-health-world/#442d379f20ba
`• https://www.europeanpharmaceuticalreview.com/article/70987/obstacles-success-
`biosimilars-us-market/
`• http://gabionline.net/Biosimilars/Research/Impact-of-proposed-changes-to-FDA-
`approach-to-biosimilars
`
`Publications
`Books (Partial List): (https://isbnsearch.org/search?s=Sarfaraz+Niazi); 170 ISBNs
`• Textbook of Biopharmaceutics and Clinical Pharmacokinetics, J Wiley & Sons, New
`York, NY, 1979; ISBN-13: 9789381075043
`• The Omega Connection, Esquire Press, Illinois, 1982; ISBN-13: 9780961784102
`• Adsorption and Chelation Therapy, Esquire Press, Illinois; 1987. ISBN-
`9780961784140
`• Attacking the Sacred Cows: The Health Hazards of Milk, Esquire Press, Illinois;
`1988; ISBN-13: 9780961784119
`• Endorphins: The Body Opium, Esquire Press, Illinois; 1988; ISBN 9780961784126
`• Nutritional Myths: The Story No One Wants to Talk About, Esquire Press, Illinois.
`ISBN 9780961784133
`• Wellness Guide. Ferozsons Publishers. Pakistan 2002. ISBN 9789690017932
`
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`• Love Sonnets of Ghalib: Translations, Explication and Lexicon, Ferozsons
`Publishers, Lahore, Pakistan 2002 and Rupa Publications, New Delhi, India 2002;
`ISBN-13: 9788171675968
`• Filing Patents Online, CRC Press, Boca Raton, Florida, 2003; ISBN-13:
`9780849316241
`• Pharmacokinetic and Pharmacodynamic Modeling in Early Drug Development in
`Charles G. Smith and James T. O'Donnell (eds.), The Process of New Drug
`Discovery and Development (2nd ed.). New York: CRC Press, 2004; ISBN-13: 978-
`0849327797.
`• Handbook of Biogeneric Therapeutic Proteins: Manufacturing, Regulatory, Testing
`and Patent Issues, CRC Press, Boca Raton, FL, 2005; ISBN-13: 9780971474611
`• Handbook of Preformulation: Chemical, Biological and Botanical Drugs, Informa
`Healthcare, New York, NY, 2006; ISBN-13: 9780849371936
`• Handbook of Bioequivalence Testing. New York: Informa Healthcare, 2007; ISBN-
`13: 978-0849303951
`• Handbook of Pharmaceutical Manufacturing Formulations, Volume 6 Second
`Edition: Sterile Products, Informa Healthcare, New York, NY, 2009; ISBN-13:
`9781420081305
`• Handbook of Pharmaceutical Manufacturing Formulations, Volume 1 Second
`Edition: Compressed Solids, Informa Healthcare, New York, NY, 2009; ISBN-13:
`9781420081169
`• Handbook of Pharmaceutical Manufacturing Formulations, Volume 2 Second
`Edition: Uncompressed Solids, Informa Healthcare, New York, NY, 2009; ISBN-13:
`9781420081183
`• Handbook of Pharmaceutical Manufacturing Formulations, Volume 3 Second
`Edition: Liquid Products, Informa Healthcare, New York, NY, 2009; ISBN-13:
`9780849317484
`• Handbook of Pharmaceutical Manufacturing Formulations, Volume 4 Second
`Edition: Semisolid Products, Informa Healthcare, New York, NY, 2009 ISBN-13:
`9781420081268;
`• Handbook of Pharmaceutical Manufacturing Formulations, Volume 5 Second
`Edition: Over the Counter Products, Informa Healthcare, New York, NY, 2009;
`ISBN-13: 978-1420081282
`• Textbook of Biopharmaceutics and Clinical Pharmacokinetics. Hyderabad, India: The
`Book Syndicate, 2010. ISBN 978-93-8107-504-3
`• Wine of Passion: Love Poems of Ghalib, Ferozsons (Pvt) Ltd., Lahore, Pakistan,
`2010; ISBN-13: 9780971474611
`• Disposable Bioprocessing Systems, CRC Press, Boca Raton, FL, 2012; ISBN-13:
`9781439866702
`• Handbook of Bioequivalence Testing. Second Edition, New York, NY: Informa
`Healthcare, 2014 ISBN-13: 9781482226379
`• There is No Wisdom: Selected Love Poems of Bedil. Translations from Darri Farsi,
`Sarfaraz K. Niazi and Maryam Tawoosi, Ferozsons Private (Ltd), Lahore, Pakistan,
`2015 ISBN 978969025036
`
`
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`• Wine of Love: Complete Translations of Urdu Persian Love Poems of Ghalib,
`Sarfaraz K. Niazi, Ferozsons Private (Ltd), Lahore, Pakistan, 2015. ISBN: TBA
`• Biosimilars and Interchangeable Biologicals: Strategic Elements. CRC Press, 2015;
`ISBN 9781482298918
`• Biosimilars and Interchangeable Biologics: Tactical Elements. CRC Press, 2015;
`ISBN 9781482298918
`• Fundamentals of Modern Bioprocessing, Sarfaraz K. Niazi and Justin L. Brown, CRC
`Press, 2015; ISBN 9781466585737
`• Biosimilarity: The FDA Perspective, CRC Press, 2018; ISBN 9781498750394
`• Handbook of Preformulation. CRC Press, 2019. ISBN 9781138297555.
`
`Inventions (Partial Listing)
`
`
`
`Checked on 14 April 2019
`
`
`Publication
`Us2018147552
`
`Title
`Zero gravity process device
`
`Us2018143754 Vehicle steering and control device (vscd)
`
`Us2018024137 Methods for comparing a structure of a first biomolecule and a second
`biomolecule
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`Multipurpose bioreactor
`Wo2017123788
`
`(a2);
`Us2017198246 Multipurpose bioreactor
`
`Us2017191015 Gas heating apparatus for disposable bioreactor
`
`Us2017136800 Angled printed bound book
`
`Us2017101435 Harvesting and perfusion apparatus
`
`Us2017051243 Recirculating bioreactor exhaust system
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`Hk1194105
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`Us2016200761
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`Us2016166949
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`Us2016097073
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`Hk1201869
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`Single-container manufacturing of biological product
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`Us2017008751 Wine preserving packaging
`
`Us2017008747 Wine preserving and aerating container
`
`Faster aging of alcoholic beverages
`Us2016376538 ;
`us9745545 (b2)
`
`Us2016301828 Visual axis optimization for enhanced readability and comprehension
`
`Us2016264930 Concentrator filter
`
`Us2016237111 Downstream bioprocessing device
`
`Buoyant protein harvesting device
`
`Preparative chromatography column and methods
`
`Purification and separation treatment assembly (pasta) for biological
`products
`
`Wo2016044758 Harvesting and purification or perfusion yielder (happy) device
`
`Us2015371120 Visual axis optimization for enhanced readability and comprehension
`
`Wo2015157494 Aeration device for bioreactors
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`Closed bioreactors
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`Interconnected bioreactors
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`Clean zone hvac system
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`Noninvasive bioreactor monitoring
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`Thermodynamic equivalence surrogate test (test) for bioequivalence
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`Bioreactor exhaust
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`Buoyant protein harvesting device
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`Comparing the structures of two biomolecules
`
`Purification and separation treatment assembly (pasta) for biological
`products
`
`Us2015275318 ;
`us9587283 (b2)
`Us2015253022 ;
`us9593859 (b2)
`Hk1201078
`
`Ep3096744 ;
`ep3096744 (a4)
`Us2015210974 ;
`us9587214 (b2)
`Us2015099293 ;
`us9290732 (b2)
`Ep3030263
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`Cn104169426
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`Us2014225727
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`Us2013220923 ;
`us8663474 (b2)
`Us2012258519
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`Us2011287404 ;
`us9499290 (b2)
`Us2011117538
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`Turning signal
`
`Wo2014018374 Baffled single-use bioreactor
`
`Wo2013188649 Pneumatically agitated and aerated single-use bioreactor
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`Non-blocking filtration system
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`Protein harvesting
`
`Us2012198600 Windy city hat
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`Us2012164300 Accelerated aging of wines and sprits
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`Stationary bubble reactors
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`Bioreactors for fermentation and related methods
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`Air scrubbing system
`Us2010316534 ;
`
`us8066947 (b2)
`Universal bioreactors and methods of use
`Us2010261226 ;
`us9550971 (b2)
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`Au2002327646 Composition and method for the treatment of hypercholesterolemia
`and hyperlipidemia in mammals
`
`Au2002248319 Pharmaceutical composition for the prevention and treatment of scar
`tissue
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`A combination of appetite controlling agents which create a synergy
`and produce a satiating result
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`Formula, system and method for treating urushiol induced contact
`dermatitis
`
`
`Au2001268731
`(a8)
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`Us4639368
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`Wo2006086065
`(a2);
`wo2006086065
`(a3)
`Us2003054020 Method and composition for reducing sebum secretion in mammals
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`Chewing gum containing a medicament and taste maskers
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`Us6419963 (b1) Composition and method for the treatment of diaper rash using
`natural products
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`Us6338862 (b1) Composition and method of use in treating sexual dysfunction using
`cgmp-specific phosphodiesterase type 5 inhibitors
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`Us6555118 (b1) Pharmaceutical preparation for the treatment of topical wounds and
`ulcers
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`Us6495174 (b1) Herbal composition for the treatment of alopecia
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`Us6312735 (b1) Method for instantaneous removal of warts and moles
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`Us6365198 (b1) Pharmaceutical preparation for the treatment of gastrointestinal
`ulcers and hemorrhoids
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`Us6251421 (b1) Pharmaceutical composition containing psyllium fiber and a lipase
`inhibitor
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`Us6235314 (b1) Analgesic, anti-inflammatory and skeletal muscle relaxant
`compositions
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`Pharmaceutical composition for the treatment of itch
`
`Us6235796 (b1) Use of fluorocarbons for the prevention of surgical adhesions
`
`Composition and method for inhibiting the absorption of nutritional
`elements from the upper intestinal tract
`
`Us2007141182 Combination of multiple non-steroidal anti-inflammatory drugs and
`muscle relaxants for local treatment of musculoskeletal pain
`
`Us2007142480 Alleviation of pain in osteoarthritis by means of intra-articular
`implantation of perfluorodecalin.
`
`Us2004253327 Compositions and methods for reducing or controlling blood
`cholesterol, lipoproteins, triglycerides, and sugar and preventing
`or treating cardiovascular diseases
`
`Pharmaceutical composition for the treatment of alopecia
`
`Suppository base
`
`Composition and method for the prevention and treatment of acne
`
`Composition and method for the treatment of diaper rash using
`Au2002310047 ;
`au2002310047
`natural products
`(a8)
`
`Au2002254428 Pharmaceutical preparation for the treatment of gastrointestinal
`ulcers and hemorrhoids
`
`
`Us6462083 (b1)
`
`Us2005013871
`
`Us4530936
`
`Us2002183297
`
`Wo02085390
`
`
`
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`Research Papers (Partial Listing):
`https://www.ncbi.nlm.nih.gov/pubmed/?term=niazi+s
`
` •
`
`Iqbal MP, Baig JA, Ali AA, Niazi SK, Mehboobali N, Hussain MA. The effects of non-
`
`steroidal anti-inflammatory drugs on the disposition of methotrexate in patients with rheumatoid
`arthritis. Biopharm Drug Dispos. 1998 Apr; 19(3):163-7.
`•
`Niazi SK, Alam SM, Ahmad SI. Partial-area method in bio- equivalence assessment:
`naproxen. Biopharm Drug Dispos. 1997 Mar;18(2):103-16.
`•
`Niazi SK, Alam SM, Ahmad SI. Dose dependent pharmacokinetics of naproxen in man.
`Biopharm Drug Dispos. 1996 May; 17(4):355-61.
`•
`Iqbal MP, Niazi SK, Mehboobali N, Zaidi AA. Disposition kinetics of aditoprim in two
`monkeys in comparison to other mammalian species. Biopharm Drug Dispos. 1995 Nov;
`16(8):713-8.
`•
`Iqbal N, Ahmad B, Janbaz KH, Gilani AU, Niazi SK. The effect of caffeine on the
`pharmacokinetics of acetaminophen in man. Biopharm Drug Dispos. 1995 Aug; 16(6):481-7.
`•
`Iqbal MP, Niazi SK, Ashfaq MK, Mahboobali N. Pharmacokinetics of aditoprim in
`normal and febrile sheep. Biopharm Drug Dispos. 1995 May; 16(4):343-9. No abstract available.
`•
`Iqbal MP, Ashfaq MK, Niazi SK, Mahboobali M, Khawaja KN. Pharmacokinetics of
`aditoprim and trimethoprim in buffalo calves. Biopharm Drug Dispos. 1994 Mar; 15(2):173-7.
`•
`Niazi SK, Hussain M. Disposition kinetics of 7, 12-dimethylbenz(a) anthracene in rats.
`Biopharm Drug Dispos. 1992 Nov; 13(8):591-6.
`•
`Ahmad M, Niazi SK, Ahmad T, Muzaffar NA, Nawaz M. Effect of dehydration on the
`disposition kinetics of erythromycin in rabbits. Biopharm Drug Dispos. 1992 Mar; 13(2):77-82.
`•
`Bhutta ZA, Niazi SK, Suria A. Chloramphenicol clearance in typhoid fever: implications
`for therapy. Indian J Pediatr. 1992 Mar-Apr; 59(2): 213-9.
`•
`Iqbal MP, Mahboobali N, Niazi SK, Mahmood MA. Pharmacokinetics of aditoprim in
`goats using a radioassay. Biopharm Drug Dispos. 1990 Aug-Sep; 11(6):533-41.
`•
`Prasad P, Niazi S, Jung D. Effect of acute water deprivation on renal function in rats.
`Biopharm Drug Dispos. 1988 May-Jun; 9(3):259-65.
`•
`Zafar NU, Niazi S, Jung D. Influence of water deprivation on the disposition of
`paracetamol. J Pharm Pharmacol. 1987 Feb; 39(2):144-7.
`•
`Prasad P, Jung D, Niazi S. Influence of short-term water deprivation on antipyrine
`disposition. J Pharm Sci. 1985 Mar; 74(3):338-9.
`•
`Prasad PP, Niazi S. Effect of water deprivation on antipyrine disposition kinetics in rats.
`Biopharm Drug Dispos. 1984 Apr-Jun; 5(2):195-8. No abstract available.
`•
`Gurwich EL, Raees SM, Skosey J, Niazi S. Unbound plasma salicylate concentration in
`rheumatoid arthritis patients. Br J Rheumatol. 1984 Feb; 23(1):66-73.
`•
`El-Rashidy R, Niazi S. A new metabolite of butylated hydroxyanisole in man. Biopharm
`Drug Dispos. 1983 Oct-Dec; 4(4):389-96.
`•
`Bakar SK, Niazi S. Effect of water deprivation on aspirin disposition kinetics. J Pharm
`Sci. 1983 Sep; 72(9):1030-4.
`•
`Bakar SK, Niazi S. Simple reliable method for chronic cannulation of the jugular vein for
`pharmacokinetic studies in rats. J Pharm Sci. 1983 Sep; 72(9):1027-9.
`•
`Bakar SK, Niazi S. Stability of aspirin in different media. J Pharm Sci. 1983 Sep;
`72(9):1024-6.
`
`
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2009
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`

`

`Bakar SK, Niazi S. High-performance liquid chromatographic determination of aspirin
`•
`and its metabolites in plasma and urine. J Pharm Sci. 1983 Sep; 72(9):1020-3.
`•
`Niazi S, Vishnupad KS, Veng-Pedersen P. Absorption and disposition characteristics of
`nitrofurantoin in dogs. Biopharm Drug Dispos. 1983 Jul-Sep; 4(3):213-23.
`•
`Ahmad T, Parveen G, Niazi S. Effect of water deprivation on chloramphenicol
`disposition kinetics in humans. J Pharm Sci. 1982 Nov; 71(11):1309-10.
`•
`Niazi S, Lim J, Bederka JP. Effect of ascorbic acid on renal excretion of lead in the rat. J
`Pharm Sci. 1982 Oct; 71(10):1189-90. No abstract available.
`•
`El-Rashidy R, Niazi S. Comparative pharmacokinetics of butylated hydroxyanisole and
`butylated hydroxytoluene in rabbits. J Pharm Sci. 1980 Dec; 69(12):1455-7.
`•
`Niazi S. Multicompartment pharmacokinetic analysis and simulations using a
`programmable calculator. Int J Biomed Comput. 1979 May; 10(3):245-55.
`•
`El-Rashidy R, Niazi S. GLC determination of butylated hydroxyanisole in human plasma
`and urine. J Pharm Sci. 1979 Jan; 68(1):103-4.
`•
`El-Rashidy R, Niazi S. Binding of butylated hydroxyanisole to human albumin using a
`Novel dynamic method. J Pharm Sci. 1 978 Jul; 67(7):967-70.
`•
`Niazi S. Thermodynamics of mercaptopurine dehydration. J Pharm Sci. 1978 Apr;
`67(4):488-91.
`•
`Bakar S, Niazi S. Simplified method to study stability of pharmaceutical systems. J
`Pharm Sci. 1978 Jan; 67(1):141.
`•
`Hussain M, Niazi S, Arambulo A, Long DM. Perfluorooctyl bromide: a potential
`antiobesity compound. J Pharm Sci. 1977 Jun; 66(6):907-8.
`•
`Huang ML, Niazi S. Polymorphic and dissolution properties of mercaptopurine. J Pharm
`Sci. 1977 Apr; 66(4):608-9.
`•
`Niazi S. Application of a programmable calculator in data fitting according to one and
`two compartment open models in clinical pharmacokinetics. Comput Programs Biomed. 1977
`Mar; 7(1):41-4.
`•
`Niazi S, Chiou WL. Fluorocarbon aerosol propellants XI: Pharmacokinetics of
`dichlorodifluoromethane in dogs following single and multiple dosing. J Pharm Sci. 1977 Jan;
`66(1):49-53.
`•
`Niazi S. Volume of distribution and tissue level errors in instantaneous intravenous input
`assumptions. J Pharm Sci. 1976 OCT; 65(10):1539-40.
`•
`Niazi S. Comparison of observed and predicted first-pass metabolism of nortriptyline in
`humans. J Pharm Sci. 1976 OCT; 65(10):1535-6.
`•
`Chiou WL, Niazi S. Pharmaceutical applications of solid dispersion systems: dissolution
`of griseofulvin-succinic acid eutectic mixture. J Pharm Sci. 1976 Aug; 65(8):1212-4.
`•
`Niazi S. Comparison of observed and predicted first-pass metabolism of imipramine in
`humans. J Pharm Sci. 1976 Jul; 65(7):1063-4.
`•
`Niazi S. Errors involved in instantaneous intravascular input assumptions. J Pharm Sci.
`1976 May; 65(5):750-2.
`•
`Niazi S. Volume of distribution as a function of time. J Pharm Sci. 1976 Mar; 65(3):452-
`4.
`Niazi S. Effect of polyethylene glycol 4000 on dissolution properties of sulfathiazole
`•
`polymorphs. J Pharm Sci. 1976 Feb; 65(2):302-4.
`•
`Niazi S, Chiou WL. Fluorocarbon aerosol propellants X: pharmacokinetics of
`dichlorotetrafluoroethane in dogs. J Pharm Sci. 1976 Jan; 65(1):60-4.
`
`
`
`11
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2009
`
`

`

`Niazi S, Chiou WL. Fluorocarbon aerosol propellants. VI: Interspecies differences in
`•
`solubilities in blood and plasma and their possible implications in toxicity studies. J Pharm Sci.
`1975 Sep; 64(9):1538-41.
`•
`Niazi S, Chiou WL. Fluorocarbon aerosol propellants IV: pharmacokinetics of
`trichloromonofluoromethane following single and multiple dosing in dogs. J Pharm Sci. 1975
`May; 64(5):763-9.
`•
`Niazi S, Chiou WL. Partition coefficients of fluorocarbon aerosol propellants in water,
`normal saline, cyclohexane, chloroform, human plasma, and human blood. J Pharm Sci. 1974
`Apr; 63(4):532-5.
`•
`Chiou WL, Niazi S. A simple and ultra-sensitive head-space gas chromatographic
`method for the assay of fluorocarbon propellants in blood. Res Commun Chem Pathol
`Pharmacol. 1973 Sep; 6(2):481-98.
`•
`Chiou WL, Niazi S. Differential thermal analysis and X-ray diffraction studies of
`griseofulvin-succinic acid solid dispersions. J Pharm Sci. 1973 Mar; 62(3):498-501.
`•
`Chiou WL, Niazi S. Phase diagram and dissolution-rate studies on sulfathiazole-urea
`solid dispersions. J Pharm Sci. 1971 Sep; 60(9):1333-338.
`
`
`
`12
`
`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2009
`
`