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Guides from Our Scientists

Practical guides on nitrosamines, bioanalysis, bioequivalence and PBPK modeling, written for pharmaceutical R&D, quality and regulatory teams.

What Are NDSRIs? Nitrosamine Drug Substance-Related Impurities Explained

How NDSRIs form, how FDA and EMA set acceptable intake limits with the CPCA, and what testing and control regulators expect.

Nitrosamine Risk Assessment: A Step-by-Step Guide for Generic Manufacturers

Risk factors to check, when to test, how to structure the report, and where SFDA and EMA expect it in the dossier.

ICH M10 Bioanalytical Method Validation: Requirements and Acceptance Criteria

Validation criteria for chromatographic and ligand binding assays, study sample rules, and what changed from FDA 2018.

PBPK Modeling in Generic Drug Development

How PBPK models work, how they are verified, and when FDA and EMA accept them in place of clinical studies.

Bioequivalence Study Design: Crossover, Replicate or Parallel?

How to choose a BE design, size the study, and meet FDA and EMA acceptance criteria.

Latest from PharmaPrimes

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Company updates, scientific activities, accreditations, new capabilities, partnerships, conferences, training, and technical content.

Evaluating the Virtual Bioequivalence of Generic Montelukast via Validated PBPK Model

Accepted for presentation at the DMDG-GMP-SPS Joint Meeting 2026 in Prague.

PharmaPrimes Contributes to New Research Paper: Quality and Safety Assessment of Bottled Water in Jordan Markets

PharmaPrimes Secures ISO/IEC 17025 Accreditation: Setting the Benchmark for Global Laboratory Excellence

PharmaPrimes Publishes Its First Peer-Reviewed Research: Advancing Analytical Excellence in Pharmaceutical Science

The Bioanalysis team at PharmaPrimes has successfully developed and validated bioanalytical methods for quantifying both Semaglutide and Liraglutide in human plasma

The Bioanalysis team at PharmaPrimes has successfully developed and validated a bioanalytical method for quantifying Semaglutide in human plasma

PharmaPrimes is participating for the first time as an official exhibitor at Arab Pharma Expo 2025, held in Amman, Jordan

Pharmaprimes Develops a Method for Bioassay of Indacaterol in Human Serum

PharmaPrimes Signs Strategic Collaboration Agreement with Global Pharma to Strengthen Local Pharmaceutical Manufacturing in the UAE

Milestone Achieved: PharmaPrimes Laboratories has been awarded GLP/GCP accreditation by the JFDA

PharmaPrimes is proud to introduce the latest breakthrough. With the launch of our Virtual Bioequivalence service, we are honored to support and elevate the entire pharmaceutical industry