BA/BE Studies

Veeda has completed over 2070+ studies including over 400 bio-studies for major pharmaceutical companies worldwide. We were inspected by several global Regulatory Authorities including USFDA, WHO, UK-MHRA, ANSM, ANVISA and MCC. Our facilities are also approved by DCGI-India. More than 985+ of our completed studies were for USFDA submission with over 110 of them having USFDA ANDA approvals.

HEALTHY
VOLUNTEER
STUDIES

Veeda is a pioneer in Bioavailability/Bioequivalence studies and has the expertise needed in a CRO partner to ensure the quality conduct of the study.

Veeda has a strong SOP driven culture and ensures compliance with all statutory and applicable Global Regulatory requirements. We provide our clients with a dedicated Project Management team to serve as a single, knowledgeable point of contact and a dedicated US, EU and ROW Business Development team that are involved and able to assist in all aspects of your studies.

CLINICAL RESEARCH DEPARTMENT

Within BA/BE studies, Veeda has an expertise in conducting the following types of studies:

STUDIES:

  • Fasting and Fed condition studies
  • Single and multiple dose
  • Drug-drug interaction (DDI)
  • Topical Transdermal Patch Studies
  • Short to Long residency Studies
  • Oral Inhalation – Pulmonary deposition & Therapeutic Equivalence Study
FORMULATIONS:
Solid Oral Formulations & Orally Dispersible Formulation
Tablets (Immediate Release & Modified Release e.g. ER, DR, SR), Capsules, Soft Gels, Sprinkles etc.
Liquid Formulations
Suspensions, Syrups & Dry power
Parenteral Formulations
07
Sprays
03
Oral Inhalation
02
Derma Patches
03
Transdermal preparations
01
male volunteers22,915+
female volunteers1,960+
patient populationOncology, HypertensiveDiabetic and Renal
elderly male1140+
post-menopausal female940+
Veeda offers such diverse variety of studies due to key capabilities like experienced manpower, established and well integrated procedures in Clinical Research department along with a vast volunteer database comprising of both young and elderly male and female volunteers. Due to such a vast and diverse volunteer pool, Veeda can offer rapid turn-around-time for study initiation, decreased lead phase for study commencement after DCGI NOC obtainment, ability to handle Generics, Phase-1 clinical trials, mixed gender studies and Patient studies.

BIOANALYTICAL LABORATORY – AHMEDABAD

Apart from Clinical Phase of BA/BE studies, Veeda has a rich experience in conducting Bioanalytical Research activities.

Veeda Bioanalytical Department consists of more than 200+ members out of which majority of the senior personnel have been associated with Veeda since inception. The Bioanalytical Team has a thorough understanding of the Physico-Chemical Properties of various drug moieties and therefore has contributed in developing a robust method library of 517+ validated methods for generic molecules and 35 methods for NCE molecules.

The subject matter expertise within the Bioanalytical department leads to consistent and reproducible performance of all the validated methods with an enviable success rate of Incurred Sample analysis to the tune of 98.8%. Using these validated assays, approximately 1000 studies have been undertaken so far.

On the scientific front, Veeda has rich expertise in following types of assays for Bioanalysis of BA/BE and Patient-based studies in human biological samples e.g. whole blood, plasma, serum, urine and stool.

SN
TYPE OF ASSAY
EXAMPLES
01
LCMSMS Assay
i
Achiral Assay(Normal Assay, Racemic Assay)
Atorvastatin + 2 Hydroxy Atorvastatin + 4 Hydroxy Atorvastatin; Bupropion + Hydroxyl Bupropion + Erythrohydro Bupropion + Threo Hydro Bupropion (2 Metabolites With Geometric Isomers); Nitroglycerin + 1, 2 Dinitroglycerin + 1, 3 Dinitroglycerin; Phenyl Butyrate + Phenyl Acetate + Phenyl Glutamine
ii
Assay for Isomers
a
Positional Isomers
Atorvastatin + 2 Hydroxy Atorvastatin + 4 Hydroxy Atorvastatin
b
Geometric Isomers
Trans and Cis Acitretin; Trans and Cis Phytonadione
c
Enantiomers(Chiral Assay)
Verapamil & Nor Verapamil; Ibuprofen; Tranylcypromine; Metoprolol; Lurasidonemetabolite 14283 & 14326
02
Assay after Derivatization
Ethinyl Estradiol + Levenogestrel ; Ergocalciferol ; Estrones, Ibuprofen (chiral)
03
Immunogenicity Testing:ELISA Assay using Micro-plate Reader
Enoxaparin
04
Elemental Bioanalysis
Iron Sucrose, Lithium
PATIENT-BASED
STUDIES

Veeda’s Clinical Operations Department has a dedicated team of experienced professionals and an elaborate network of Clinical Trial sites across India to offer the patient based BE studies with Pharmacokinetic and clinical end-point studies.

UNIQUE FEATURES OF OUR SPECIALIZED TEAM FOR PATIENT PHARMACOKINETIC STUDIES
  • Knowledge-based, quality oriented staff
  • Database of pre-screened experienced and GCP-trained Investigators / sites for all therapeutic indications
  • Key opinion leaders (KOLs) onboard – Consultants with vast experience in study design, conduct and safety aspects of Clinical Trials
  • Study Design and Protocol Development
  • Project managers and CRAs experienced in planning, executing Clinical endpoint studies, Pharmacokinetic studies in patient population and Phase II / III studies

We have so far completed 4 Phase II Global Clinical trials and 7 Patient based Pharmacokinetic studies with 15 more studies in the pipeline. We have completed study design and comprehensive feasibility for more than 30 generic molecules for pharmacokinetic studies in patient population, and more than 15 molecules requiring clinical end-point studies. The level of expertise and in-depth insight in clinical operations and

project management helps us predict the risks and challenges in the study design and execution and mitigate them during study planning and set-up. All such advantages due to our experienced personnel are included in our service offering modalities. Some of the therapeutic segments which will help us initiate studies at a shorter notice are

Therapeutic areas for Pharmacokinetic Studies
  • Oncology
  • Psychiatry
  • Ophthalmology
Therapeutic areas for Clinical Endpoint Studies
  • Dermatology
  • Ophthalmology
  • Gastroenterology
  • Orthopedics
  • ENT

 

HEALTHY
VOLUNTEER
STUDIES

 

 

PATIENT-BASED
STUDIES