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Semler Research Centre

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Semler Research Centre

Bioavailability & Bioequivalence

Bangalore



A Quality Product from
Semler Research Centre [View Profile]
Bangalore - India

Description :
"We are experts in conducting studies for local and international regulatory submissions and have the necessary infrastructure to support our proficiency. With unparalleled method development and validation processes and access to vast volunteer pools, early phase studies at Semler Research Center are poised to take a quantum leap."- Umesh B A, Vice President, Corporate Development.

Semler Research Center (SRC) offers two state-of-the art pharmacology centers in India to conduct early phase pharmacological and drug developmental studies. We leverage the team's combined experience of over 50 years in conducting over 750 drug studies ranging in size from 40-400 volunteers in various therapeutic areas for various regulatory submissions. SRC serves the bio-pharmaceutical market by conducting quality bioavailability & bioequivalence studies both economically and efficiently.

Our services are end-to-end and customized to meet each client's specific requirements. The studies are ably supported by our bio-analytical team with in-depth expertise in generating methods that are accurate, precise, selective, sensitive and reproducible. Our proficiency is constantly upgraded to meet evolving requirements for various approvals, including novel therapeutic drugs, generic drugs and post–approval formulation changes. We have over 240 methods readily available. The bioanalytical team also supports complex pharmacokinetic studies in patients conducted by the clinical development team for early exploratory, investigative or screening studies which support regulatory submissions.

Bioanalytical

Semler Research Center(SRC) offers a unique combination of highly trained workforce enabled with well-equipped bioanalytical laboratory. We are committed to conducting studies as per sponsor specifications while maintaining highest standards of quality, regulatory requirements and adherence to timelines.

Every study conducted is supervised by a dedicated study director, who monitors all phases of the project, from receipt and inventory of reference materials and samples to preparation of the final report. We ensure that each client has direct access and periodic updates from the scientist/s who are associated with project.

Strict security measures and policies are adopted to ensure that our clients receive services that match the highest levels of compliance without any breach of confidentiality. We have experimental procedures performed in compliance to ICH/FDA guidelines and can be modified to suit user specific requirements.
Key Bioanalytical Services

Method development
Method validation
Method transfer
Analysis of clinical study samples by HPLC and LC-MS/MS
Analysis of in vitro ADME and in vivo PK/ADME samples by HPLC and LC-MS/MS
Analysis of drug and metabolites in different biological fluids by HPLC and LC-MS/MS
Analysis of toxico-kinetic study samples by HPLC and LC-MS/M

Pharmacokinetics & Pharmacodynamics

Semler Research Center(SRC) offers pharmacokinetic(PK) and pharmacodynamic(PD) services to ascertain the time course of individual exposure and response to a new treatment regime. Studies are conducted to establish therapeutic schedules, evaluate their relevance, or evaluate dose adjustments in particular patient population. Our capabilities in PK include early exploratory, investigative or screening studies and to support regulatory submissions.

Our Pharmacokineticists, work closely with our statistical, scientific writing and bioanalytical staff at every stage of the study. From initiation to completion and reporting, they ensure a smooth and effective transition of high-quality pharmacokinetic data from our bioanalytical laboratory to the pharmacokinetics department and then to our statistical and medical writing groups. Finally team coordinates in the preparation of comprehensive ICH compliant reports.

PK and PD in Patients

SRC offers a complete range of research services in the areas of pharmacokinetic and ADME studies for small molecules, large molecules, biologics and other related test articles and devices. The studies are conducted to establish therapeutic schedules, to evaluate their relevance or for dose adjustments in particular patients.

Key PK & PD Offerings

Input to study design, including pre-clinical to clinical considerations (allometric scaling) utilizing information from pre-clinical toxico-kinetic studies
Non-compartmental pharmacokinetics
Compartmental pharmacokinetics/simulations
Ascending dose (assessment of dose proportionality)
Repeat dose (assessment of steady-state kinetics and multiple dose linearity)
Bioavailability and bioequivalence
Drug interaction studies
Special population studies
Pharmacodynamic and PK/PD modeling
Deconvolution
Comprehensive text interpretation of data


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Semler Research Centre

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