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@lambdatherapeutic
The CRC at LTR provides unreserved support to the site and thus covers guidance for all aspects of imaging in a clinical trial. Every project is spearheaded by industry experienced team of certified graders and imaging research associates. We also offer a full range of central review services and consultation for a wide range of therapeutic segments for its sponsors.
Potential Biomarker in Diagnosis and Prognosis of Various Diseases
The new biomarkers have shown good potential for important decision-making in diagnosis as well as prognosis of various diseases in clinical practice. Copeptin can be one of these biomarkers as compared to Arginine vasopressin (AVP).
AVP is easily stimulated by exposure of the body to endogenous stress but measurement of AVP concentration becomes difficult because it is subject to pre-analytical and analytical errors, therefore not used in clinical practice. Whereas Copeptin is a part of precursor pre-vasopressin (pre-proAVP). Activation of the AVP system stimulates Copeptin secretion into the circulation from the posterior pituitary gland in equimolar amounts with AVP and thus can be used as a surrogate biomarker.
https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=108
Potential Biomarker in Severity, predictive and Prognostic bio-marker of Atopic Dermatitis
Atopic dermatitis can be treated according to a "one-size-fits-all" approach, which could affect the efficacy of the treatment provided.AD diagnosis is based on clinical criteria like SCORAD, EASI, and IGA, which are observers' subjective assessments. Hence, there was a need for the identification of reliable biomarkers that could reduce observatory differences and would be useful objective parameters for diagnosis, disease severity measurement, and especially for the development of precision medicine.
Impact of Immunogenicity on the Pharmacokinetics and Pharmacodynamics of Biosimilars
Due to An increasing utilization and approvals of biosimilars, immunogenicity has become a significant concern which needs to be assessed due to its potential impact on the efficacy and safety of the molecule. With the use of biological products, individuals sometimes tend to develop immunogenicity, due to which the body's immune system produces anti-drug antibodies (ADA), which further bind to various epitopes of the circulating molecule, varying its effects in terms of pharmacokinetics and/or efficacy or safety of the molecule.
https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=106
Choose the Ideal Qualified Person for Pharmacovigilance (QPPV)
A qualified person for pharmacovigilance (QPPV) acts as a main/single pharmacovigilance contact point for the competent authorities for marketing authorization Holder (MAH) and the European Medicine Agency (EMA)/ the Medicines and Healthcare products Regulatory Agency (MHRA) on a 24-hour basis. They also serve as a contact point for all pharmacovigilance inspections by any competent authority, any state authority, and the EMA/MHRA. As a one-stop solution provider, Lambda provides highly qualified QPPVs and deputy QPPVs having rich experience and expertise in Pharmacovigilance activities, along with quality management systems.
https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=110
Simpler, Swifter & Smarter In-vitro Methods for Bioequivalence Studies, Decoded
A simple, precise, and accurate, reverse-phase, ultra-performance liquid chromatography tandem mass spectrometric bioanalytical method was developed for the quantitative determination of bile acids [glycocholic acid (GCA), glycochenodeoxycholic acid (GCDA), and taurodeoxycholic acid (TDCA)] in an in-vitro bile acid-binding study of Colesevelam HCl tablets.
The separation was achieved using a Poroshell EC C18 2.7µm 4.6 x 100mm column with a mobile phase containing solvent A consisting of methanol and solvent B consisting of 2mM Ammonium formate buffer (80:20) with a total run time of 6.0 minutes.
https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=104
Partner with Lambda for customized solutions at a project, program and compound level in paediatric drug development. Successful Navigation of complex regulatory pathways and requirements, Preparation of PIP, PIP waiver, deferral, PUMA, PDCO submission to, modification of PIP, compliance check.
A Highly Sensitive LC-MS/MS method for the quantification of Desmopressin in human plasma
Desmopressin is a synthetic analog of vasopressin used to reduce renal excretion of water in patients with central diabetes insipidus and doctors.
https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=105
It has been employed clinically since 1972 and is available in various formulations, including intranasal solution, intravenous solution, oral tablet, and oral lyophilisate. The active ingredient in most formulations is desmopressin acetate. The absolute bioavailability of orally administered desmopressin varies between 0.08% and 0.16 .Because of its low bioavailability, the peak plasma concentration of desmopressin after oral administration is very low.
Lambda is one of the best Drug Safety and Pharmacovigilance services to our regional customers as per client requirements. Our teams are focused on safety in clinical trials and other activities and are ready to help with your project.
Bioequivalence studies in India | Bioequivalence CRO | Lambda
Lambda's Bioavailability/Bioequivalence Studies are backed by excellent scientific expertise and global access to 1000+ clinical beds. We offer a full range of bioequivalence clinical trial services in Ahmedabad, India. we have a team of experts who will guide you through any of your queries on the Bioequivalence Studies.
Phase I Clinical Trials Companies In India | Lambda
Lambda is one of the leaders in Late Phase Clinical Research in India, A team of experts equipped to conduct trials in multiple geographies. Lambda has successfully executed over 43 phase-1 studies in the last 5 years for various formulations including Oral, Parenteral, Inhalers, Topical, Transdermal, Nasal Sprays, Injectables, Pessaries, Suppositories etc.
Late phase clinical trials Companies in India | Lambda
Lambda is a one of the leaders in Late Phase Clinical Research in India, A highly qualified team of executives and specialists leads our Lambda Research and Late Phase Research efforts with years of clinical, observational, and economic research experience. we’re committed to getting the details
Clinical Research Organization and Trial Companies in India
Lambda’s advanced Central Laboratory is supported by Clinical Pathologists, Microbiologists, Biotechnologists and Medical Technologists offering diverse services. we are a leading global Clinical Research Organization and one of the best clinical trials in India and best Clinical data management company.
Lambda offers a one stop solution for Biosimilar studies. offers high quality and accurate Best Bioanalytical Labs in India. Lambda' Bioavailability/Bioequivalence Studies offer global access to 800+ clinical beds inclusive of 85+ specialized beds designed for specific studies.
Bioanalytical Labs play an important role in the pharmaceutical industry, as they are responsible for conducting bioequivalence studies…
bioequivalence studies
India is rapidly becoming a hub for medical imaging services and bioanalytical labs. This is due to the availability of specialized clinica...
These companies have access to the latest technologies and equipment, which enable them to deliver accurate results in a timely manner.
Lambda is one of the best Clinical Research Organizations in India. It provides comprehensive clinical trial services that enable customers to bring their products to market quickly and cost-effectiv…