Preclinical studies dosage forms

Phase I studies evaluate the pharmacokinetics and safety of the drug in a small number (tens) of healthy volunteers. Phase I studies are sometimes conducted in a small patient population (Proof of Concept studies) with a specific objective such as the validation of the relevance of preclinical models in man. The purpose of these studies may be the rapid elimination of potential failures from the pipeline, definition of biological markers for efficacy or toxicity, or demonstration of early evidence of efficacy. These studies have a potential go/no-go decision criteria such as safety, tolerability, bioavailability/PK, pharmacodynamics, and efficacy. Dosage forms used in Phase I or Proof of Concept studies must be developed with the objectives of the clinical study in mind. 

Preclinical testing and development and development of new and coprocessed excipients (Chapters 3, 6, 9, and 20) This section describes the type of preclinical testing that is required in support of the development and registration of new excipients and presents a case study for successful development of a novel excipient. Lastly, Chapter 20 looks to the future and identifies excipients needed for innovative biotechnologically derived dosage forms. 

Link between formulations and dosage forms used in preclinical, clinical, pharmacokinetic/pharmacodynamic studies, and formulations planned for the NDA or BLA... 

Veterinary Drug Availability, Basis for Selection 3 of the Dosage Form, Formulation of Veterinary Dosage Forms, Protein/Peptide Veterinary Formulations, Formulation of Vaccines, Administration Devices and Techniques, Specification Development and Stability Assessment, Bioavailability Bioequivalence Assessments, Development and Formulation of Dosage Forms, Design of Preclinical Studies... 

The pharmacokinetic profile of a product or substance describes its fate in the organism with respect to the absoption, distribution, metabolism and elimination. For chemical compounds pharmacokinetic data form the basis for an assessment of pharmacodynamic and toxic effects and allow a rationale for a dosage regime to be established for preclinical and clinical studies. 

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