Analytical Services
- Leachable and extractable studies
- Cleaning method validation (Residue studies)
- Force degradation studies
- Photo stability studies
- Genotoxic impurity analysis
- Packaging screening study
- Chiral method development
- Technology transfer
- Physical characterisation
- Dissolution studies
- Reverse engineering
- Comparison studies
Bio-equivalence Studies
- Bioequivalence (BE) is essential for development and approval of generic drugs.
- As Per 21 CFR 320.1, BE is defined as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
Invitro Binding Studies
- Invitro Binding studies is of two different types. 1. In Vitro Kinetic Binding Study 2. In Vitro Equilibrium Binding Study
- As per Guidance by FDA Pretreatment will be performed for respective product.
In Vitro Kinetic Binding Study
- Assess the rate of binding and the time to reach the binding equilibrium.
- Support equilibrium binding study.
- Methods: -Prepare two (or three) adsorbate (e.g., phosphate)concentrations: usually correspond to the lowest and highest concentrations (plus middle concentration) in the equilibrium study.
- Incubate test and reference for at least eight different lengths of time. The selected time should demonstrate that maximum binding is established.
In Vitro Equilibrium Binding Study
- Considered as the pivotal BE study
- Evaluate binding affinity (k1) and capacity (k2) constants
- Conducted under conditions of constant time and varying adsorbate concentrations
Sampling Time
- Equilibrium Studies - Single Time Point
- Kinetic Studies - Multiple Time Points
- Number Of Replicates For Each Study : Twelve (12 times)