Services
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 validation
of bioanalytical methods for protein and small molecule drugs in biological matrices.
IND, NDA, CTD Preparation
Pharmacokinetics and GLP Toxicokinetics Reports
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.
- 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 validation
of 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
IND, NDA, CTD Preparation
- 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
Pharmacokinetics and GLP Toxicokinetics Reports
- Ciencia Group can analyze your pharmacokinetic and toxicokinetic
bioanalytical data and prepare pharmacokinetics and GLP toxicokinetics
reports for FDA submissions.
 |
| |
 |
| |
 |
| |
 |