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Copyright 2016 Dennis Sandell All Rights Reserved

Services


The consulting services typically provided by S5 are based on expert knowledge and experiences in three areas:

  • CMC statistics
  • Authoring regulatory documentation
  • Development of inhalation products.

S5 is happy to discuss statistical support also in other areas, with the exception that S5 does not provide statistical support for planning and evaluation of clinical trials.

S5 can also assist with raw data entry (paper to excel or similar) using some experienced students.

CMC statistics


The most common consulting service provided by S5 is design and evaluation of in-vitro bioequivalence experiments, most often based on impactor testing. Typical applications include innovator/generic comparisons, method transfers, validation of device, formulation & process changes, comparison of clinical to to-be-marketed product, and justification of dose/actuation counters and breath actuators. There are many considerations involved for maximizing the chance for succesful results, including design, sizing of study, statistical evaluation and acceptance criteria.

Other typical areas of CMC statistics work for S5 include

  • Establishment/verification of specifications
  • Evaluation of stability data
  • Justification of shelf-life
  • Development of statistical process control routines
  • Design of experiments for various development studies.

S5 Consulting has significant experience from evaluating in-vivo/in-vitro correlation (IVIVC) for inhalation products. This includes both trying to establish the link between collected impactor and PK data, for the purpose of modifying one product to match the performance of the other, as well as developing the protocol to ensure optimal collection of both impactor and PK data.

Authoring regulatory documentation


Dennis has long experience from authoring presentations, reports and documents for regulatory submissions. He is an excellent writer and has the ability to describe the data and statistical evaluations in an easy asseccible way; in particular Dennis put much effort into innovative approaches describing relationships and comparisons in graphical form. Typical areas where Dennis’ experiences best are used are stability, pharmaceutical development, justification of specifications, in-vitro equivalence and drug product characterization studies.

S5 Consulting is happy to author/co-author scientific papers on behalf of a customer, and to represent its customers at meeting with regulators.

Other typical areas of CMC statistics work for S5 include

  • Establishment/verification of specifications
  • Evaluation of stability data
  • Justification of shelf-life
  • Development of statistical process control routines
  • Design of experiments for various development studies.

Development of inhalation products


Dennis has more than 20 years of experience from inhalation development. Although he surely is no analytical chemist, pharmacist or device engineer, he has worked with those in many projects and been involved in designing and evaluating many of the typical development studies, thereby gained a deep understanding of the characteristics and limitations of different device and formulations types. Dennis has long experience of experiments for

  • Micronization / blending / spheronization
  • Device development / optimization
  • Filling and assembly
  • Robustness / mis-use / in-use
  • Method development & validation
  • Automated / robotic testing
  • Drug product characterization studies
  • Stability testing
  • Device user studies.