Dual Success Across Time Zones - Successfully Supported MHRA and FDA Inspections for Pharmacovigilance Services
Dual Success Across Time Zones: Successfully Supported PV Inspections for MHRA and FDA,
NEWS
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…
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…
Lambda proudly marks yet another consecutive GLP compliance certification at our Ahmedabad Laboratory facility since 2014, by the National GLP Compliance Monitoring Authority (NGCMA).
Lambda Ahmedabad Facility Achieves Consecutive GLP Compliance Certification
NEWS
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
Blog
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.
BLOG
Advancing Iron Analysis: Method Development for Ferric Carboxymaltose-Associated Iron Measurement
Advancing Iron Analysis: Method Development for FCM-Associated Iron Measurement
BLOG
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The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.”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.
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.
Full-service_Global_CRO_Top_Leading_Clinical_Research_Organization
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…
- Go to the previous page
- 1
- …
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- …
- 14
- Go to the next page