Overview

Cadila Pharmaceuticals Sweden offers a complete pre-clinical development program at a fixed price to make your candidate drug ready for first-in-human clinical trial application in Europe, while keeping your development costs under control.

Development work is performed or procured by Cadila Pharmaceutical´s experienced pre-clinical and formulation/CMC departments, following relevant GLP and GMP guidelines to ensure full regulatory compliance.

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Key facts

The Fixed price IND package includes formulation development, product supply and preclinical studies typically needed for a first-in-human clinical trial in Europe.

All projects will be led by a dedicated project manager at Cadila to ensure seamless program execution.

The base package assumes an oral product, and that primary pharmacology, panel screening, placebo and API (synthesis and characterisation) is provided by the customer. It is also possible to have these parts quoted separately, and to tailor the program also in other aspects for your specific needs.

The fixed price of the complete standard package is 900 000 USD.

Details and deliverables

The pre-clinical studies of the program include the activities normally required by European authorities for a first-in-man (FIM) clinical study of an oral product. The experimental scope is subject to certain limitations – please contact us for further details.

CMC activities included in the package are formulation development and supply of drug product for first clinical trial, including release for clinical trial in Europe.

In addition to individual reports from all activities, deliverables of the complete package also includes IMPD writing for data from work performed by Cadila as part of the package.

See list below for all studies and activities included in the package.

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Preclinical studies

ADME

  • Metabolic stability in vitro
  • CYP substrate, inhibition and induction profile
  • Plasma protein binding
  • Stability in plasma/blood
  • Cell permeability and transporter assays
  • PK in rodent
  • PK in non-rodent
  • Red blood cell partitioning

Genotoxicity studies

  • AMES (GLP)
  • Micronucleus in vivo
  • Chromosomal abberations

Toxicology studies

  • DRF (7-14 day repeat-dose) in rodent
  • DRF (7-14 day repeat-dose) in non-rodent
  • 4 week repeat-dose in rodent (GLP)
  • 4 week repeat-dose toxicity study in non-rodent (GLP)
  • Phototoxicity

Safety pharmacology core battery

  • Irwin´s test (CNS activity) in rodent
  • Studies of cardiovascular effects (in vitro hERG and in vivo telemetry)
  • Study on respiratory effects
CMC Activities

Physico-chemical properties

  • Identity/purity/pKa/log P
  • log Kd/Solubility

Formulation development for preclinical studies

  • Manufacturing of pre-GLP formulations
  • Stability data and pH dependence of selected formulation for preclinical studies

Analytical development

  • Stage 1
    • Development of methods for pharmaceutical analysis
    • Limited pharmaceutical/chemical characterization of scale-up batches
  • Stage 2
    • Validation of methods for pharmaceutical analysis of API (GMP)
    • Chemical characterization of API
    • Test and release of API and reference standard (GMP)
    • Stability studies on API and reference standard (GMP)
    • Validation of methods for pharmaceutical analysis of GLP formulations (GMP)
    • Stability studies on GLP formulations (GMP)
    • Validation of methods for pharmaceutical analysis of FIM formulations (GMP)
    • Stability studies on FIM clinical supplies (GMP)

Drug product

  • Selection of dosage form and development of formulation for FIM study
  • Manufacturing FIM clinical supplies (GMP)
  • Packaging and labelling

Regulatory

  • Formatting of data obtained in package into IMPD suitable for submission to European authorities
  • Clinical trial material released for European clinical trial use

IMPD drafting in general or for other data (e.g. pharmacology, clinical, prior studies) to be quoted separately or provided by collaborator.

Contact us

For further information or in case of any questions, please contact us by e-mail to FixedPriceIND@cadilasweden.se,
or by calling us directly: +46 8 524 820 51. You can also download the Fixed IND package flyer.