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selected peer-reviewed research articles

1: Niazi SK. The Coming of Age of AI/ML in Drug Discovery, Development, Clinical

Testing, and Manufacturing: The FDA Perspectives. Drug Des Devel Ther. 2023 Sep

6;17:2691-2725. doi: 10.2147/DDDT.S424991. PMID: 37701048; PMCID: PMC10493153.

2: Niazi SK. A Proposed Global Medicines Agency (GMA) to Make Biological Drugs

Accessible: Starting with the League of Arab States. Healthcare (Basel). 2023

Jul 20;11(14):2075. doi: 10.3390/healthcare11142075. PMID: 37510516; PMCID:

PMC10379659.

3: Niazi SK, Mariam Z. Recent Advances in Machine-Learning-Based

Chemoinformatics: A Comprehensive Review. Int J Mol Sci. 2023 Jul

15;24(14):11488. doi: 10.3390/ijms241411488. PMID: 37511247; PMCID: PMC10380192.

4: Niazi SK. RNA Therapeutics: A Healthcare Paradigm Shift. Biomedicines. 2023

Apr 25;11(5):1275. doi: 10.3390/biomedicines11051275. PMID: 37238946; PMCID:

PMC10216086.

5: Niazi SK. Biosimilars Adoption: Recognizing and Removing the RoadBlocks.

Clinicoecon Outcomes Res. 2023 Apr 12;15:281-294. doi: 10.2147/CEOR.S404175.

PMID: 37077364; PMCID: PMC10106314.

6: Niazi SK, Al-Shaqha WM, Mirza Z. Proposal of International Council for

Harmonization (ICH) Guideline for the Approval of Biosimilars. J Mark Access

Health Policy. 2022 Nov 17;11(1):2147286. doi: 10.1080/20016689.2022.2147286.

PMID: 36419638; PMCID: PMC9677983.

7: Niazi SK. The Inflation Reduction Act: A boon for the generic and biosimilar

industry. J Clin Pharm Ther. 2022 Nov;47(11):1738-1751. doi: 10.1111/jcpt.13783.

Epub 2022 Oct 7. PMID: 36207987; PMCID: PMC9828046.

8: Niazi SK. Molecular Biosimilarity-An AI-Driven Paradigm Shift. Int J Mol Sci.

2022 Sep 14;23(18):10690. doi: 10.3390/ijms231810690. PMID: 36142600; PMCID:

PMC9505197.

9: Niazi SK. No two classes of biosimilars: Urgent advice to the US Congress and

the FDA. J Clin Pharm Ther. 2022 Sep;47(9):1352-1361. doi: 10.1111/jcpt.13743.

Epub 2022 Jul 22. PMID: 35869625; PMCID: PMC9796791.

10: Niazi SK. Making COVID-19 mRNA vaccines accessible: challenges resolved.

Expert Rev Vaccines. 2022 Sep;21(9):1163-1176. doi:

10.1080/14760584.2022.2089121. Epub 2022 Jun 17. PMID: 35695469.

11: Niazi S. Scientific Rationale for Waiving Clinical Efficacy Testing of

Biosimilars. Drug Des Devel Ther. 2022 Aug 24;16:2803-2815. doi:

10.2147/DDDT.S378813. PMID: 36043044; PMCID: PMC9420434.

12: Niazi SK. End animal testing for biosimilar approval. Science. 2022 Jul

8;377(6602):162-163. doi: 10.1126/science.add4664. Epub 2022 Jul 7. PMID:

35857557.

13: Niazi SK. Biosimilars: A futuristic fast-to-market advice to developers.

Expert Opin Biol Ther. 2022 Feb;22(2):149-155. doi:

10.1080/14712598.2022.2020241. Epub 2021 Dec 27. PMID: 34913776.

14: Niazi SK. Comment on "The End of Phase 3 Clinical Trials in Biosimilars

Development?". BioDrugs. 2019 Feb;33(1):121-123. doi: 10.1007/s40259-018-0330-1.

PMID: 30604391.

15: Niazi SK, Alam SM, Ahmad SI. Partial-area method in bioequivalence

assessment: naproxen. Biopharm Drug Dispos. 1997 Mar;18(2):103-16. doi:

10.1002/(sici)1099-081x(199703)18:2<103::aid-bdd4>3.0.co;2-s. PMID: 9099447.

16: Niazi SK, Alam SM, Ahmad SI. Dose dependent pharmacokinetics of naproxen in

man. Biopharm Drug Dispos. 1996 May;17(4):355-61. doi:

10.1002/(SICI)1099-081X(199605)17:4<355::AID-BDD960>3.0.CO;2-N. PMID: 8743406.

17: 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. doi: 10.1002/bdd.2510160810. PMID: 8573690.

18: 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. doi: 10.1002/bdd.2510160606. PMID: 7579030.

19: 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. doi:

10.1002/bdd.2510160410. PMID: 7548783.

20: 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. doi: 10.1002/bdd.2510150209. PMID: 8011968.

21: Niazi SK, Hussain M. Disposition kinetics of 7,12-dimethylbenz(a)anthracene

in rats. Biopharm Drug Dispos. 1992 Nov;13(8):591-6. doi:

10.1002/bdd.2510130805. PMID: 1421052.

22: 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. doi: 10.1002/bdd.2510130202. PMID: 1550910.

23: Bhutta ZA, Niazi SK, Suria A. Chloramphenicol clearance in typhoid fever:

implications for therapy. Indian J Pediatr. 1992 Mar-Apr;59(2):213-9. doi:

10.1007/BF02759987. PMID: 1398851.

24: 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.

doi: 10.1002/bdd.2510110607. PMID: 2207303.

25: 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. doi:

10.1002/bod.2510090304. PMID: 3395667.

26: Zafar NU, Niazi S, Jung D. Influence of water deprivation on the disposition

of paracetamol. J Pharm Pharmacol. 1987 Feb;39(2):144-7. doi:

10.1111/j.2042-7158.1987.tb06965.x. PMID: 2882004.

27: Prasad P, Jung D, Niazi S. Influence of short-term water deprivation on

antipyrine disposition. J Pharm Sci. 1985 Mar;74(3):338-9. doi:

10.1002/jps.2600740325. PMID: 4009446.

28: Prasad PP, Niazi S. Effect of water deprivation on antipyrine disposition

kinetics in rats. Biopharm Drug Dispos. 1984 Apr-Jun;5(2):195-8. doi:

10.1002/bdd.2510050213. PMID: 6743786.

29: El-Rashidy R, Niazi S. A new metabolite of butylated hydroxyanisole in man.

Biopharm Drug Dispos. 1983 Oct-Dec;4(4):389-96. doi: 10.1002/bdd.2510040410.

PMID: 6661516.

30: Bakar SK, Niazi S. Effect of water deprivation on aspirin disposition

kinetics. J Pharm Sci. 1983 Sep;72(9):1030-4. doi: 10.1002/jps.2600720916. PMID:

6631688.

31: 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. doi: 10.1002/jps.2600720915. PMID: 6631687.

32: Bakar SK, Niazi S. Stability of aspirin in different media. J Pharm Sci.

1983 Sep;72(9):1024-6. doi: 10.1002/jps.2600720914. PMID: 6631686.

33: 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. doi: 10.1002/jps.2600720913. PMID: 6631685.

34: 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. doi: 10.1002/bdd.2510040303. PMID: 6626697.

35: 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. doi:

10.1002/jps.2600711136. PMID: 7175736.

36: 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. doi:

10.1002/jps.2600711033. PMID: 7143226.

37: El-Rashidy R, Niazi S. Comparative pharmacokinetics of butylated

hydroxyanisole and butylated hydroxytoluene in rabbits. J Pharm Sci. 1980

Dec;69(12):1455-7. doi: 10.1002/jps.2600691233. PMID: 7463340.

38: Niazi S. Multicompartment pharmacokinetic analysis and simulations using a

programmable calculator. Int J Biomed Comput. 1979 May;10(3):245-55. doi:

10.1016/0020-7101(79)90015-1. PMID: 489156.

39: El-Rashidy R, Niazi S. GLC determination of butylated hydroxyanisole in

human plasma and urine. J Pharm Sci. 1979 Jan;68(1):103-4. doi:

10.1002/jps.2600680134. PMID: 758441.

40: El-Rashidy R, Niazi S. Binding of butylated hydroxyanisole to human albumin

using a novel dynamic method. J Pharm Sci. 1978 Jul;67(7):967-70. doi:

10.1002/jps.2600670726. PMID: 660518.

41: Niazi S. Thermodynamics of mercaptopurine dehydration. J Pharm Sci. 1978

Apr;67(4):488-91. doi: 10.1002/jps.2600670413. PMID: 641755.

42: Bakar S, Niazi S. Simplified method to study stability of pharmaceutical

systems. J Pharm Sci. 1978 Jan;67(1):141. doi: 10.1002/jps.2600670144. PMID:

619108.

43: Hussain M, Niazi S, Arambulo A, Long DM. Perfluorooctyl bromide: a potential

antiobesity compound. J Pharm Sci. 1977 Jun;66(6):907-8. doi:

10.1002/jps.2600660654. PMID: 874807.

44: Huang ML, Niazi S. Polymorphic and dissolution properties of mercaptopurine.

J Pharm Sci. 1977 Apr;66(4):608-9. doi: 10.1002/jps.2600660446. PMID: 853378.

45: 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. doi: 10.1016/0010-468x(77)90035-6. PMID:

849682.

46: 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. doi: 10.1002/jps.2600660111. PMID: 833741.

47: Niazi S. Volume of distribution and tissue level errors in instantaneous

intravenous input assumptions. J Pharm Sci. 1976 Oct;65(10):1539-40. PMID:

978419.

48: Niazi S. Comparison of observed and predicted first-pass metabolism of

nortriptyline in humans. J Pharm Sci. 1976 Oct;65(10):1535-6. doi:

10.1002/jps.2600651031. PMID: 978417.

49: 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. doi: 10.1002/jps.2600650820. PMID: 978439.

50: Niazi S. Comparison of observed and predicted first-pass metabolism of

imipramine in humans. J Pharm Sci. 1976 Jul;65(7):1063-4. doi:

10.1002/jps.2600650727. PMID: 957114.

51: Niazi S. Errors involved in instantaneous intravascular input assumptions. J

Pharm Sci. 1976 May;65(5):750-2. doi: 10.1002/jps.2600650534. PMID: 932951.

52: Niazi S. Volume of distribution as a function of time. J Pharm Sci. 1976

Mar;65(3):452-4. doi: 10.1002/jps.2600650339. PMID: 1263103.

53: Niazi S. Effect of polyethylene glycol 4000 on dissolution properties of

sulfathiazole polymorphs. J Pharm Sci. 1976 Feb;65(2):302-4. doi:

10.1002/jps.2600650233. PMID: 1255470.

54: Niazi S, Chiou WL. Fluorocarbon aerosol propellants X: pharmacokinetics of

dichlorotetrafluoroethane in dogs. J Pharm Sci. 1976 Jan;65(1):60-4. doi:

10.1002/jps.2600650111. PMID: 1255437.

55: 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. doi:

10.1002/jps.2600640926. PMID: 810571.

56: 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. doi: 10.1002/jps.2600640507. PMID: 1151644.

57: 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. doi: 10.1002/jps.2600630408.

PMID: 4828699.

58: 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. PMID: 4750098.

59: 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. doi: 10.1002/jps.2600620336. PMID: 4691717.

60: Chiou WL, Niazi S. Phase diagram and dissolution-rate studies on

sulfathiazole-urea solid dispersions. J Pharm Sci. 1971 Sep;60(9):1333-8. doi:

10.1002/jps.2600600908. PMID: 5567578.