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CRO’s with experience in providing biostatistical services, contractor selection and supervision with wide experience with biostatistics, pharmacokinetics, and bioanalytics. Bioavailability and Bioequivalence studies or Relative BE/BA studies can be Single & multiple dose studies, Food Effect studies, Cross over and parallel studies, Replicate studies. BA/BE studies are conducted in extremely controlled environment and all the clinical, bioanalytical and data management activities are strictly driven through SOPs. The studies are conducted as per the ethical committee approved protocol, SOPs, current GCP, GLP standards and applicable regulatory requirements. Bioequivalence studies have become an essential requirement for registering new pharmaceutical/biopharmaceutical products in markets across the world during clinical research or clinical trials. Strict adherence to GCP is practiced in overall conduct of all the studies(like ADME etc.) and conducting studies for various routes of delivery and formulations like Tablets, Capsules, Solutions, Suspensions, Syrups, Sprays, and Suppositories etc. has become a major pre-requisite for pharmaceutical companies. Bioanalytical department of major CRO’s are equipped with wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc. The monitoring of all the steps of a BA/BE study aims to ensure that all study data is obtained and processed in compliance with the clinical protocol and local legislation, ensuring the participant’s well-being first and, consequently, good results for the pharmaceutical industry in charge and for the population who will soon have access to a new generic/biosimilar drug. These studies are also done for isotopically labelled drug. Fully integrated service for BE studies includes Relative bioavailability of established and experimental formulations, Single and multiple-dose (Steady state) kinetic studies, Fasting / Food-effect kinetic studies, Drug interaction studies, Studies comparing Immediate and modified release formulations, Pharmacodynamics studies, Studies comparing various Routes of Administration, Studies in Healthy Volunteers / Special Population, Oral Bioavailability studies, Absolute Bioavailability etc.

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Celerion

Dalmia

ICBio Clinical Research Pvt Ltd

Navitas Inc

QUINTA-ANALYTICA s.r.o

Quotient Sciences

Reliance Clinical Testing Services, Inc

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CZECH REPUBLIC

INDIA

UNITED KINGDOM

UNITED STATES

Virtual BoothQuinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Phase I Clinical Trials & BE/BA Study

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Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

Virtual BoothTransforming Drug Development with Science & Innovation.

Bioavailability & Dose Proportionality

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Quotient has the experience and expertise to seamlessly deliver several studies involving bioavailability, dose proportionality, absolute bioavailability, bioequivalence, food effect, thorough QT (TQT) / cardiac safety, biosimilars, pharmacodynamics etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

Virtual BoothTransforming Drug Development with Science & Innovation.

Bioavailability / Bioequivalence Studies

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- Service Details

Quotient has the experience and expertise to seamlessly deliver several studies involving bioavailability, dose proportionality, absolute bioavailability, bioequivalence, food effect, thorough QT (TQT) / cardiac safety, biosimilars, pharmacodynamics etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Claims Substantiation & Efficacy Testing

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Claims substantiation plays a key role in a product’s success and helps ensure the product stands out against competitors. From moisturization and barrier function, to anti-aging and color changes, rely on RCTS for your product claims substantiation and efficacy testing needs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Generic Drugs / Biosimilars

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Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Biosimilars

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Celerion leverages more than 30 years of biologics drug development experience to enable early assessment viability of biosimilars, and bridge the gap between newly sourced products and patient studies.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Bioavailability & Bioequivalence Studies

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- Service Details

BA/BE Studies are conducted at ICBio are in strict Compliance with International regulatory requirements monitored by QA department. We have considerable experience in conducting BA/BE studies on healthy & patient population with various dosage forms.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Bioavailability / Bioequivalence Studies

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- Service Details

We deliver the Bioavailability/ Bioequivalence study projects with high quality standards as per the set regulatory guidelines to ensure the efficacy and safety of each pharmaceutical products.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Bioavailability & Bioequivalence Studies

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- Service Details

With a highly qualified and experienced team in place, Navitas can deliver even complicated studies with high quality outputs.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Biologics & Biosimilars Studies

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- Service Details

Navitas' experience across innovator pharma and biologic Phase III studies, and pharmacokinetic studies enables us to partner with you to meet accelerated submission timelines while optimizing trial costs and regulatory risk of non-compliance.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

CRO’s with experience in providing biostatistical services, contractor selection and supervision with wide experience with biostatistics, pharmacokinetics, and bioanalytics. Bioavailability and Bioequivalence studies or Relative BE/BA studies can be Single & multiple dose studies, Food Effect studies, Cross over and parallel studies, Replicate studies. BA/BE studies are conducted in extremely controlled environment and all the clinical, bioanalytical and data management activities are strictly driven through SOPs. The studies are conducted as per the ethical committee approved protocol, SOPs, current GCP, GLP standards and applicable regulatory requirements. Bioequivalence studies have become an essential requirement for registering new pharmaceutical/biopharmaceutical products in markets across the world during clinical research or clinical trials. Strict adherence to GCP is practiced in overall conduct of all the studies(like ADME etc.) and conducting studies for various routes of delivery and formulations like Tablets, Capsules, Solutions, Suspensions, Syrups, Sprays, and Suppositories etc. has become a major pre-requisite for pharmaceutical companies. Bioanalytical department of major CRO’s are equipped with wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc. The monitoring of all the steps of a BA/BE study aims to ensure that all study data is obtained and processed in compliance with the clinical protocol and local legislation, ensuring the participant’s well-being first and, consequently, good results for the pharmaceutical industry in charge and for the population who will soon have access to a new generic/biosimilar drug. These studies are also done for isotopically labelled drug. Fully integrated service for BE studies includes Relative bioavailability of established and experimental formulations, Single and multiple-dose (Steady state) kinetic studies, Fasting / Food-effect kinetic studies, Drug interaction studies, Studies comparing Immediate and modified release formulations, Pharmacodynamics studies, Studies comparing various Routes of Administration, Studies in Healthy Volunteers / Special Population, Oral Bioavailability studies, Absolute Bioavailability etc.

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