Sarfaraz K. Niazi

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GOOD Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Sarfaraz K. Niazi, 2019 .

Pharmaceutical Development

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations.

Handbook of Preformulation: Chemical, Biological, and Botanical Drugs

Sarfaraz K. Niazi, 2006 .

Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products

Sarfaraz K. Niazi, 2019 .

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products

Sarfaraz Niazi, Sarfaraz K Niazi, Sarfaraz K. Niazi, 2004 .

Pharmacokinetics–Pharmacodynamics in New Drug Development

Sarfaraz K. Niazi, 2006, Drug Discovery and Development.

Characterization of Phytomedicines

Sarfaraz K. Niazi, 2006 .

Characterization of Biopharmaceutical Drugs

Sarfaraz K. Niazi, 2006 .

Impurities in New Drug Products

Sarfaraz Niazi, Sarfaraz K. Niazi, 2016 .

Stability Testing: Photostability Testing of New Drug Substances and Products

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations.

Pharmaceutical Development

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

Sarfaraz K. Niazi, 2004, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition.

Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition.

Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.

Sarfaraz K. Niazi, 1998, Developments in biological standardization.

Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Sarfaraz Niazi, Sarfaraz K. Niazi, 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Impurities in New Drug Substances

Sarfaraz Niazi, Sarfaraz K. Niazi, 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Impurities in New Drug Products

Sarfaraz K. Niazi, 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Pharmaceutical Development in CTD

Sarfaraz K. Niazi, 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Validation of Analytical Procedures

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations.

Pharmaceutical Manufacturing Formulations

Sarfaraz K. Niazi, 2009, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Pharmacokinetic and pharmacodynamic properties of a new biosimilar filgrastim TPI G-CSF in comparison to the marketed reference filgrastim Neupogen®: a double-blind, single-dose, two-period crossover trial

Sarfaraz K. Niazi, A. Bourgoin, 2015 .

Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products

Sarfaraz Niazi, Sarfaraz K. Niazi, 2009 .

Waiver of in Vivo Bioequivalence Study

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection

Sarfaraz Niazi, Sarfaraz K. Niazi, 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

Quality Risk Management

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations.

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Sarfaraz K. Niazi, 2009 .

Over-the-counter products

Sarfaraz K. Niazi, 2004 .

The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars

Sarfaraz K. Niazi, 2023, Pharmaceuticals.

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

Sarfaraz K. Niazi, Matthias Magoola, 2023, Biologics.

Stability Testing of Biotechnological/Biological Products

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition.

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

Sarfaraz K. Niazi, 2023, Clinical pharmacology in drug development.

Handbook of Pharmaceutical Manufacturing Formulations, Second Edition

Sarfaraz K. Niazi, 2021 .

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

Sarfaraz K. Niazi, Zamara Mariam, 2023, Pharmaceuticals.

Anti-Idiotypic mRNA Vaccine to Treat Autoimmune Disorders

Sarfaraz K. Niazi, 2023, Vaccines.

Handbook of Bioequivalence Testing

Sarfaraz Niazi, Sarfaraz K. Niazi, 2007 .

Formulation Factors in Semisolid Dosage Forms

Sarfaraz K. Niazi, 2016 .

Limitations of Protein Structure Prediction Algorithms in Therapeutic Protein Development

R. Z. Paracha, Sarfaraz K. Niazi, Zamara Mariam, 2024, BioMedInformatics.

Glucagon‐like peptide agonists: A prospective review

Sarfaraz K. Niazi, Zamara Mariam, 2023, Endocrinology, diabetes & metabolism.

Impurities: Guideline for Residual Solvents

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations.

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition.

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

Sarfaraz K. Niazi, 2023, Pharmaceutics.

Gene Editing: The Regulatory Perspective

Sarfaraz K. Niazi, 2023, Encyclopedia.

Engineered Antibodies to Improve Efficacy against Neurodegenerative Disorders

Sarfaraz K. Niazi, Zamara Mariam, Matthias Magoola, 2024, International journal of molecular sciences.

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

Sarfaraz K. Niazi, Matthias Magoola, 2024, Biomedicines.

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

Sarfaraz K. Niazi, Zamara Mariam, Matthias Magoola, 2024, Pharmaceuticals.

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

Sarfaraz K. Niazi, S. Omarsdottir, 2024, International journal of molecular sciences.

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

Sarfaraz K. Niazi, 2024, International Journal of Molecular Sciences.

Validation of Analytical Procedures

Sarfaraz K. Niazi, 2019, Handbook of Pharmaceutical Manufacturing Formulations.