Professional Services
Preclinical toxicokinetic (TK), pharmacokinetic (PK) and clinical PK studies - Ciencia Group can assist in developing GLP and non-GLP preclinical protocols for TK and PK studies for topical, IV, PO, and SC dosing in mouse, rat, dog, monkey, and swine. Ciencia can assist in the preclinical and clinical trial study design, data interpretation, and preparation of the reports. The products of these activities will support worldwide regulatory submissions.
Pharmacology services include study design, conduct, data analysis, report writing and submissions.
Toxicology - Ciencia Group can assist in the toxicology study design, data interpretation, and preparation of the reports.
Assay Development Ciencia Group can assist in the development and validationof bioanalytical methods for protein and small molecule drugs in biological matrices.
- Non-compartmental data analyses for preclinical PK and TK studies using WinNonlin
- Non-compartmental data analyses for clinical Phase I and Phase II PK studies.
- Predictive and population PK/pharmacodynamic (PD) modeling using NONMEM
- Non-compartmental PK analysis of Phase I bioavailability/bioequivalence, food effect, drug interaction, and special population studies
- Population PK analysis of sparse PK samples in Phase II/III studies
- In vitro-in vivo correlations (IVIVC) of sustained-release formulations using convolution and deconvolution techniques
- Prepare for and participate in FDA meetings
- Selection and oversight of contract research organizations (CROs)
Pharmacology services include study design, conduct, data analysis, report writing and submissions.
- Select CROs for pharmacodyanic preclinical models and assist in protocol design
- Provide project management and oversight
Toxicology - Ciencia Group can assist in the toxicology study design, data interpretation, and preparation of the reports.
- Selection and oversight of contract laboratories
- Strategic development and implementation of prelinical safety programs
- Draft and/or review internal prelinical safety reports
- Draft and/or review of prelinical toxicology sections for ICH regulatory submissions
- Due diligence for in-license opportunities
- Prepare for and participate in FDA meetings
- Good Laboratory Practices (GLP) and study monitor training
- Provide project management and oversight
Assay Development Ciencia Group can assist in the development and validationof bioanalytical methods for protein and small molecule drugs in biological matrices.
- Assist in bioanalytical assay development and validation for protein or small molecule drug in plasma, serum, or urine
- Review bioanalytical reports
- Assist in developing and validating assays to measure the immunogenicity of protein drugs
- Prepare antibodies for use as reagents in assays
- Selection and oversight of contract laboratories
- Prepare nonclinical Pharmacology/Toxicology, Bioanalytical, and PK sections for IND, NDA and CTD documents for FDA or EMEA submissions
- Prepare Clinical PK sections for IND, NDA and CTD documents for FDA or EMEA submissions
- Participate in FDA and EMEA meetings
- Ciencia Group can analyze your pharmacokinetic and toxicokinetic bioanalytical data and prepare pharmacokinetics and GLP toxicokinetics reports for FDA submissions.