Works matching AU Niazi, Sarfaraz K.

Results: 56

Quantum Mechanics in Drug Discovery: A Comprehensive Review of Methods, Applications, and Future Directions.

Published in:

International Journal of Molecular Sciences, 2025, v. 26, n. 13, p. 6325, doi. 10.3390/ijms26136325

By:

Niazi, Sarfaraz K.

Publication type:

Article

FINCHES: A Computational Framework for Predicting Intermolecular Interactions in Intrinsically Disordered Proteins.

Published in:

International Journal of Molecular Sciences, 2025, v. 26, n. 13, p. 6246, doi. 10.3390/ijms26136246

By:

Niazi, Sarfaraz K.

Publication type:

Article

Regulatory Perspectives for AI/ML Implementation in Pharmaceutical GMP Environments.

Published in:

Pharmaceuticals (14248247), 2025, v. 18, n. 6, p. 901, doi. 10.3390/ph18060901

By:

Niazi, Sarfaraz K.

Publication type:

Article

Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies.

Published in:

Pharmaceuticals (14248247), 2025, v. 18, n. 6, p. 779, doi. 10.3390/ph18060779

By:

Niazi, Sarfaraz K.

Publication type:

Article

Support for Removing Pharmacodynamic and Clinical Efficacy Testing of Biosimilars: A Critical Analysis.

Published in:

Clinical Pharmacology in Drug Development, 2023, v. 12, n. 12, p. 1134, doi. 10.1002/cpdd.1349

By:

Niazi, Sarfaraz K.

Publication type:

Article

Affordable mRNA Novel Proteins, Recombinant Protein Conversions, and Biosimilars—Advice to Developers and Regulatory Agencies.

Published in:

Biomedicines, 2025, v. 13, n. 1, p. 97, doi. 10.3390/biomedicines13010097

By:

Niazi, Sarfaraz K.

Publication type:

Article

Safety Concerns in Neurological Clinical Trials: A Challenge That the FDA Must Resolve.

Published in:

Biomedicines, 2024, v. 12, n. 12, p. 2918, doi. 10.3390/biomedicines12122918

By:

Niazi, Sarfaraz K.

Publication type:

Article

Transcytosis-Driven Treatment of Neurodegenerative Disorders by mRNA-Expressed Antibody–Transferrin Conjugates.

Published in:

Biomedicines, 2024, v. 12, n. 4, p. 851, doi. 10.3390/biomedicines12040851

By:

Niazi, Sarfaraz K.;
Magoola, Matthias

Publication type:

Article

RNA Therapeutics: A Healthcare Paradigm Shift.

Published in:

Biomedicines, 2023, v. 11, n. 5, p. 1275, doi. 10.3390/biomedicines11051275

By:

Niazi, Sarfaraz K.

Publication type:

Article

Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars.

Published in:

Journal of Market Access & Health Policy, 2023, v. 11, n. 1, p. 1, doi. 10.1080/20016689.2022.2147286

By:

Niazi, Sarfaraz K.;
Al-Shaqha, Waleed Mohammed;
Mirza, Zafar

Publication type:

Article

Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products.

Published in:

Pharmaceutics, 2024, v. 16, n. 8, p. 1013, doi. 10.3390/pharmaceutics16081013

By:

Niazi, Sarfaraz K.

Publication type:

Article

The United States Food and Drug Administration's Platform Technology Designation to Expedite the Development of Drugs.

Published in:

Pharmaceutics, 2024, v. 16, n. 7, p. 918, doi. 10.3390/pharmaceutics16070918

By:

Niazi, Sarfaraz K.

Publication type:

Article

Non-Invasive Drug Delivery across the Blood–Brain Barrier: A Prospective Analysis.

Published in:

Pharmaceutics, 2023, v. 15, n. 11, p. 2599, doi. 10.3390/pharmaceutics15112599

By:

Niazi, Sarfaraz K.

Publication type:

Article

Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective.

Published in:

2025

By:

Mirakhori, Fahimeh;
Niazi, Sarfaraz K.

Publication type:

Literature Review

GnRH Peptide Antagonist: Comparative Analysis of Chemistry and Formulation with Implications for Clinical Safety and Efficacy.

Published in:

2025

By:

Patel, Shikha;
Saxena, Bhagawati;
Mehta, Priti;
Niazi, Sarfaraz K.

Publication type:

Literature Review

Advice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven.

Published in:

Pharmaceuticals (14248247), 2024, v. 17, n. 11, p. 1424, doi. 10.3390/ph17111424

By:

Niazi, Sarfaraz K.

Publication type:

Article

Innovative Therapeutic Strategies in Alzheimer's Disease: A Synergistic Approach to Neurodegenerative Disorders.

Published in:

Pharmaceuticals (14248247), 2024, v. 17, n. 6, p. 741, doi. 10.3390/ph17060741

By:

Niazi, Sarfaraz K.;
Magoola, Matthias;
Mariam, Zamara

Publication type:

Article

Computer-Aided Drug Design and Drug Discovery: A Prospective Analysis.

Published in:

Pharmaceuticals (14248247), 2024, v. 17, n. 1, p. 22, doi. 10.3390/ph17010022

By:

Niazi, Sarfaraz K.;
Mariam, Zamara

Publication type:

Article

A Critical Analysis of the FDA's Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity.

Published in:

Pharmaceuticals (14248247), 2023, v. 16, n. 11, p. 1556, doi. 10.3390/ph16111556

By:

Niazi, Sarfaraz K.

Publication type:

Article

The FDA's New Guideline "Generally Accepted Scientific Knowledge" (GASK): An Opportunity to Expedite the Approval of Biosimilars.

Published in:

Pharmaceuticals (14248247), 2023, v. 16, n. 11, p. 1517, doi. 10.3390/ph16111517

By:

Niazi, Sarfaraz K.

Publication type:

Article

Anti-Idiotypic mRNA Vaccine to Treat Autoimmune Disorders.

Published in:

Vaccines, 2024, v. 12, n. 1, p. 9, doi. 10.3390/vaccines12010009

By:

Niazi, Sarfaraz K.

Publication type:

Article

Biosimilars Adoption: Recognizing and Removing the RoadBlocks.

Published in:

ClinicoEconomics & Outcomes Research, 2023, v. 15, p. 281, doi. 10.2147/CEOR.S404175

By:

Niazi, Sarfaraz K

Publication type:

Article

The Coming of Age of AI/ML in Drug Discovery, Development, Clinical Testing, and Manufacturing: The FDA Perspectives.

Published in:

Drug Design, Development & Therapy, 2023, v. 17, p. 2691, doi. 10.2147/DDDT.S424991

By:

Niazi, Sarfaraz K

Publication type:

Article

Bioavailability as Proof to Authorize the Clinical Testing of Neurodegenerative Drugs—Protocols and Advice for the FDA to Meet the ALS Act Vision.

Published in:

International Journal of Molecular Sciences, 2024, v. 25, n. 18, p. 10211, doi. 10.3390/ijms251810211

By:

Niazi, Sarfaraz K.

Publication type:

Article

Lectin-Based Fluorescent Comparison of Glycan Profile—FDA Validation to Expedite Approval of Biosimilars.

Published in:

International Journal of Molecular Sciences, 2024, v. 25, n. 17, p. 9240, doi. 10.3390/ijms25179240

By:

Niazi, Sarfaraz K.;
Omarsdottir, Sesselja

Publication type:

Article

Engineered Antibodies to Improve Efficacy against Neurodegenerative Disorders.

Published in:

International Journal of Molecular Sciences, 2024, v. 25, n. 12, p. 6683, doi. 10.3390/ijms25126683

By:

Niazi, Sarfaraz K.;
Mariam, Zamara;
Magoola, Matthias

Publication type:

Article

Recent Advances in Machine-Learning-Based Chemoinformatics: A Comprehensive Review.

Published in:

International Journal of Molecular Sciences, 2023, v. 24, n. 14, p. 11488, doi. 10.3390/ijms241411488

By:

Niazi, Sarfaraz K.;
Mariam, Zamara

Publication type:

Article

Molecular Biosimilarity—An AI-Driven Paradigm Shift.

Published in:

International Journal of Molecular Sciences, 2022, v. 23, n. 18, p. N.PAG, doi. 10.3390/ijms231810690

By:

Niazi, Sarfaraz K.

Publication type:

Article

Gene Editing: The Regulatory Perspective.

Published in:

Encyclopedia, 2023, v. 3, n. 4, p. 1345, doi. 10.3390/encyclopedia3040096

By:

Niazi, Sarfaraz K.

Publication type:

Article

Making COVID-19 mRNA vaccines accessible: challenges resolved.

Published in:

Expert Review of Vaccines, 2022, v. 21, n. 9, p. 1163, doi. 10.1080/14760584.2022.2089121

By:

Niazi, Sarfaraz K.

Publication type:

Article

The effects of non-steroidal anti-inflammatory drugs on the disposition of methotrexate in patients with rheumatoid arthritis.

Published in:

Biopharmaceutics & Drug Disposition, 1998, v. 19, n. 3, p. 163, doi. 10.1002/(SICI)1099-081X(199804)19:3<163::AID-BDD82>3.0.CO;2-L

By:

Iqbal, M. Perwaiz;
Baig, Javed A.;
Ali, Azra A.;
Niazi, Sarfaraz K.;
Mehboobali, N.;
Hussain, M. Azmat

Publication type:

Article

PARTIAL-AREA METHOD IN BIOEQUIVALENCE ASSESSMENT: NAPROXEN.

Published in:

Biopharmaceutics & Drug Disposition, 1997, v. 18, n. 2, p. 103, doi. 10.1002/(SICI)1099-081X(199703)18:2<103::AID-BDD4>3.0.CO;2-S

By:

NIAZI, SARFARAZ K.;
ALAM, SYED M.;
AHMAD, SYED I.

Publication type:

Article

DOSE DEPENDENT PHARMACOKINETICS OF NAPROXEN IN MAN.

Published in:

Biopharmaceutics & Drug Disposition, 1996, v. 17, n. 4, p. 355, doi. 10.1002/(SICI)1099-081X(199605)17:4<355::AID-BDD960>3.0.CO;2-N

By:

Niazi, Sarfaraz K.;
Alam, S. Mahmood;
Ahmad, S. I.

Publication type:

Article

Disposition kinetics of aditoprim in two monkeys in comparison to other mammalian species.

Published in:

Biopharmaceutics & Drug Disposition, 1995, v. 16, n. 8, p. 713, doi. 10.1002/bdd.2510160810

By:

Iqbal, M. Perwaiz;
Niazi, Sarfaraz K.;
Mehboobali, N.;
Zaidi, Arif A.

Publication type:

Article

Pharmacokinetics of aditoprim in normal and febrile sheep.

Published in:

Biopharmaceutics & Drug Disposition, 1995, v. 16, n. 4, p. 343, doi. 10.1002/bdd.2510160410

By:

Iqbal, M. Perwaiz;
Niazi, Sarfaraz K.;
Ashfaq, M. Khalid;
Mahboobali, N.

Publication type:

Article

Advances in Escherichia coli -Based Therapeutic Protein Expression: Mammalian Conversion, Continuous Manufacturing, and Cell-Free Production.

Published in:

Biologics, 2023, v. 3, n. 4, p. 380, doi. 10.3390/biologics3040021

By:

Niazi, Sarfaraz K.;
Magoola, Matthias

Publication type:

Article

mRNA and Synthesis-Based Therapeutic Proteins: A Non-Recombinant Affordable Option.

Published in:

Biologics, 2023, v. 3, n. 4, p. 355, doi. 10.3390/biologics3040020

By:

Niazi, Sarfaraz K.;
Magoola, Matthias

Publication type:

Article

The Dawn of In Vivo Gene Editing Era: A Revolution in the Making.

Published in:

Biologics, 2023, v. 3, n. 4, p. 253, doi. 10.3390/biologics3040014

By:

Niazi, Sarfaraz K.

Publication type:

Article

Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies.

Published in:

Biologics, 2023, v. 3, n. 2, p. 72, doi. 10.3390/biologics3020005

By:

Niazi, Sarfaraz K.;
Mariam, Zamara

Publication type:

Article

Biosimilars: Harmonizing the Approval Guidelines.

Published in:

Biologics, 2022, v. 2, n. 3, p. 171, doi. 10.3390/biologics2030014

By:

Niazi, Sarfaraz K.

Publication type:

Article

The Coming of Age of Biosimilars: A Personal Perspective.

Published in:

Biologics, 2022, v. 2, n. 2, p. 107, doi. 10.3390/biologics2020009

By:

Niazi, Sarfaraz K.

Publication type:

Article

Unlocking the Future of Drug Development: Generative AI, Digital Twins, and Beyond.

Published in:

BioMedInformatics, 2024, v. 4, n. 2, p. 1441, doi. 10.3390/biomedinformatics4020079

By:

Mariam, Zamara;
Niazi, Sarfaraz K.;
Magoola, Matthias

Publication type:

Article

Limitations of Protein Structure Prediction Algorithms in Therapeutic Protein Development.

Published in:

BioMedInformatics, 2024, v. 4, n. 1, p. 98, doi. 10.3390/biomedinformatics4010007

By:

Niazi, Sarfaraz K.;
Mariam, Zamara;
Paracha, Rehan Z.

Publication type:

Article

Biosimilars: A futuristic fast-to-market advice to developers.

Published in:

Expert Opinion on Biological Therapy, 2022, v. 22, n. 2, p. 149, doi. 10.1080/14712598.2022.2020241

By:

Niazi, Sarfaraz K.

Publication type:

Article

Glucagon‐like peptide agonists: A prospective review.

Published in:

Endocrinology, Diabetes & Metabolism, 2024, v. 7, n. 1, p. 1, doi. 10.1002/edm2.462

By:

Mariam, Zamara;
Niazi, Sarfaraz K.

Publication type:

Article

Comment on “The End of Phase 3 Clinical Trials in Biosimilars Development?”.

Published in:

BioDrugs, 2019, v. 33, n. 1, p. 121, doi. 10.1007/s40259-018-0330-1

By:

Niazi, Sarfaraz K.

Publication type:

Article

Current Progress and Future Perspectives of RNA-Based Cancer Vaccines: A 2025 Update.

Published in:

Cancers, 2025, v. 17, n. 11, p. 1882, doi. 10.3390/cancers17111882

By:

Magoola, Matthias;
Niazi, Sarfaraz K.

Publication type:

Article

Placebo Effects: Neurological Mechanisms Inducing Physiological, Organic, and Belief Responses—A Prospective Analysis.

Published in:

Healthcare (2227-9032), 2024, v. 12, n. 22, p. 2314, doi. 10.3390/healthcare12222314

By:

Niazi, Sarfaraz K.

Publication type:

Article

A Proposed Global Medicines Agency (GMA) to Make Biological Drugs Accessible: Starting with the League of Arab States.

Published in:

Healthcare (2227-9032), 2023, v. 11, n. 14, p. 2075, doi. 10.3390/healthcare11142075

By:

Niazi, Sarfaraz K.

Publication type:

Article

The Quantum Paradox in Pharmaceutical Science: Understanding Without Comprehending—A Centennial Reflection.

Published in:

International Journal of Molecular Sciences, 2025, v. 26, n. 10, p. 4658, doi. 10.3390/ijms26104658

By:

Niazi, Sarfaraz K.

Publication type:

Article