Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach

ISBN-13: 9780367779511 / Angielski / Miękka / 2021 / 220 str.

Arkadiy Pitman; Oleksandr Sverdlov; L. Bruce Pearce

Opis

Discusses integral, pragmatic approach to solving problems relevant to biostatistics function in the pharmaceutical industry, emphasizes importance of logical, systematic thinking, clear problem formulation and answering research questions in selected terms.

Spis treści

Answers to Inevitable Questions. A Road to an Integral Approach: Atlas and Caryatid of Biostatistics. Atlas–Statistical Programming. Caryatid–Data Management. Further Down the Road: Where and How We Live–Tactical Aspects. Environment: Biostatistics in the Regulatory Science Setting. Toolkit: Pharmacometrics. Broadening the View: Making Life Interesting–Strategic Aspects. Environment Enhancement: Teaching Statistical Concepts to Medical Colleagues. Where Should We Go?–Portfolio Optimization– and How Can We Do It Faster?–Adaptive Clinical Development Strategies. What Are We Measuring? And How Should We Do This?–Development of New Validated Scoring Systems. Can We Survive Mistakes?–Resurrecting a Failed Clinical Program. Can We Predict Unpredictable?–Planning the Timelines of Real-Life Open-Ended Projects.

O autorze

Arkadiy Pitman, MSc is senior director of biostatistics and data management at HBO2 Therapeutics. His experience includes over 20 years of teaching mathematics, logic, statistics, and computer science, as well as over 20 years of work in US small pharma environment, covering data management, statistical programming, biostatistics, regulatory, and medical writing.

Oleksandr Sverdlov, PhD is neuroscience disease area lead statistician in early clinical development at Novartis Pharmaceuticals. He has been actively involved in research on adaptive designs for clinical trials and edited a monograph Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects (CRC Press).

L. Bruce Pearce, PhD has background in pharmacology and toxicology. Since 2009 he has served as a consultant to very early and late stage biotechnology and pharmaceutical companies for the development of small molecule-based drugs, biotechnology-derived natural and recombinant biotherapeutics, and medical devices.