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…

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Read more about the article Clinical Research Update – Lambda Newsletter – June 2024
Clinical Research Updates - June 2024 Newsletter

Clinical Research Update – Lambda Newsletter – June 2024

Regulations, Notices & Guidance June 10, 2024: The FDA announced the "Emerging Drug Safety Technology Meetings; Program Announcement." The Center for Drug Evaluation and Research (CDER) introduced the Emerging Drug…

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Read more about the article Overcoming Challenges in a Multicenter Psychiatry Clinical Trial: Bioequivalence Assessment of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg
Overcoming Challenges in a Multicenter Psychiatric Clinical Trial: Bioequivalence Assessment of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg

Overcoming Challenges in a Multicenter Psychiatry Clinical Trial: Bioequivalence Assessment of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg

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Read more about the article Poster presented at 18th WRIB: Singlicate well assay for the analysis of Enoxaparin PD Biomarkers (Anti-Factor Xa, Anti-Factor IIa, and TFPI) for the Bioequivalence study.
WRIB Poster -Singlicate well assay for the analysis of Enoxaparin Pharmacodynamic Biomarkers (Anti-Factor Xa, Anti-Factor IIa, and TFPI) for the Bioequivalence study. - Poster presented at 18th WRIB

Poster presented at 18th WRIB: Singlicate well assay for the analysis of Enoxaparin PD Biomarkers (Anti-Factor Xa, Anti-Factor IIa, and TFPI) for the Bioequivalence study.

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Continue ReadingPoster presented at 18th WRIB: Singlicate well assay for the analysis of Enoxaparin PD Biomarkers (Anti-Factor Xa, Anti-Factor IIa, and TFPI) for the Bioequivalence study.
Read more about the article FDA’s New Draft Guidances on Cancer Clinical Trials Eligibility Criteria
FDA Issues New Draft Guidances On Cancer Clinical Trial Eligibility Criteria

FDA’s New Draft Guidances on Cancer Clinical Trials Eligibility Criteria

The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.

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Read more about the article Exploring the Evolving Landscape of Ophthalmology Clinical Development
Leading CRO for Ophthalmology clinical development - clinical trials

Exploring the Evolving Landscape of Ophthalmology Clinical Development

Few fields in clinical research are as dynamic and promising as ophthalmology. With the global population ageing and eye diseases becoming more prevalent, there is a growing demand for innovative treatments and therapies. This blog explores the emerging trends and updates that are shaping the ophthalmology clinical development landscape.

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Read more about the article Empowering Biotech and Pharma: The Vital Role of Full-Service CROs
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Empowering Biotech and Pharma: The Vital Role of Full-Service CROs

In the dynamic landscape of biotech and pharma, the role of a full-service CRO is more crucial than ever. CROs serve as invaluable partners for biotech and pharma, offering comprehensive…

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