Read more about the article Transdermal and Topical Products: Early Phase BA BE Study Capabilities
Transdermal and Topical Products Early Phase BA BE Study Capabilities Lambda CRO

Transdermal and Topical Products: Early Phase BA BE Study Capabilities

Lambda conducts early phase BA/BE studies for transdermal and topical products with a focus on pharmacokinetics, adhesion performance, and skin safety. Experience spans multiple molecules and dosage forms, supported by controlled application techniques and consistent study execution.

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Read more about the article Accelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)
Accelerated Study Start for BABE Programs in India with CDSCO Prior Intimation Pathway (CT-05) Lambda CRO

Accelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)

The regulatory environment in 2025 was defined by consolidation, clarification, and higher expectations for execution. Across major regions, regulators focused on improving trial quality, reducing avoidable administrative burden, and enabling scientific progress while maintaining patient safety and data integrity.

Continue ReadingAccelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)
Read more about the article Navigating Challenges in a Single-Dose Study to Evaluate Pharmacokinetic and Immunogenicity Endpoints of a Recombinant Humanized mAb
Navigating Challenges in a Single-Dose Study of a Recombinant Humanized mAb to Evaluate Pharmacokinetic and Immunogenicity Endpoints.

Navigating Challenges in a Single-Dose Study to Evaluate Pharmacokinetic and Immunogenicity Endpoints of a Recombinant Humanized mAb

Study Overview: Conducting clinical studies for monoclonal antibodies (MABs) involves meticulous planning and execution, especially for recombinant humanized mAbs administered via intravenous (i.v.) infusion. This Recombinant humanized mAb targets subdomain…

Continue ReadingNavigating Challenges in a Single-Dose Study to Evaluate Pharmacokinetic and Immunogenicity Endpoints of a Recombinant Humanized mAb