Big data analysis of global advances in pharmaceutics and drug delivery 1980-2014.

This review provides a comprehensive perspective of the global research advances and frontiers in pharmaceutics from 1980 to 2014. Furthermore, a historical view and future prospects of drug delivery are discussed.

Vaccine technologies: From whole organisms to rationally designed protein assemblies.

Vaccines have been the single most significant advancement in public health, preventing morbidity and mortality in millions of people annually. Vaccine development has traditionally focused on whole organism vaccines, either live attenuated or inactivated vaccines. While successful for many different infectious diseases whole organisms are expensive to produce, require culture of the infectious agent, and have the potential to cause vaccine associated disease in hosts. With advancing technology and a desire to develop safe, cost effective vaccine candidates, the field began to focus on the development of recombinantly expressed antigens known as subunit vaccines. While more tolerable, subunit vaccines tend to be less immunogenic. Attempts have been made to increase immunogenicity with the addition of adjuvants, either immunostimulatory molecules or an antigen delivery system that increases immune responses to vaccines. An area of extreme interest has been the application of nanotechnology to vaccine development, which allows for antigens to be expressed on a particulate delivery system. One of the most exciting examples of nanovaccines are rationally designed protein nanoparticles. These nanoparticles use some of the basic tenants of structural biology, biophysical chemistry, and vaccinology to develop protective, safe, and easily manufactured vaccines. Rationally developed nanoparticle vaccines are one of the most promising candidates for the future of vaccine development.

G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 12, 413-420, 1995--backstory of BCS.

The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.

Keeping a critical eye on the science and the regulation of oral drug absorption: a review.

This review starts with an introduction on the theoretical aspects of biopharmaceutics and developments in this field from mid-1950s to late 1970s. It critically addresses issues related to fundamental processes in oral drug absorption such as the complex interplay between drugs and the gastrointestinal system. Special emphasis is placed on drug dissolution and permeability phenomena as well as on the mathematical modeling of oral drug absorption. The review ends with regulatory aspects of oral drug absorption focusing on bioequivalence studies and the US Food and Drug Administration and European Medicines Agency guidelines dealing with Biopharmaceutics Classification System and Biopharmaceutic Drug Disposition Classification System.

A history of biopharmaceutics in the Food and Drug Administration 1968-1993.

The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions it was to have, and the implementation of that authority are described. The determination of bioequivalence, the bioavailability decision rules, pharmacokinetics, and drug metabolism are explained. The reason for the development of the Scale-Up and Post Approval Regulations and how they were developed are also explained.

Implications of biosimilars for the future.

PURPOSE: Historical perspective on the use of biotechnology for drug product development, terminology used for biotechnology drug products, potential benefits of biotechnology, applications of biotechnology to drug product development, pharmacy considerations in the use of biopharmaceuticals, and the classification of biotechnology products by the Food and Drug Administration (FDA) are discussed. SUMMARY: Applications of biotechnology to medicine have a long history, and the pace of new applications has accelerated in recent decades. Various terms, including biosimilars, follow-on biologics, and follow-on proteins, have been used to refer to biotechnology products that are highly similar to the reference product, notwithstanding minor differences. New approaches to the production of drug products have been made feasible through biotechnology, facilitating the prevention, cure, and treatment of diseases. Recombinant DNA technology, monoclonal antibodies, and gene therapy are among the applications of biotechnology processes to drug development. Storage, handling, preparation, and administration are among the pharmacy considerations in the use of biopharmaceuticals. The FDA has not defined or developed a pathway for establishing therapeutic equivalence of biosimilar and innovator products. Payers may attempt to make decisions about therapeutic equivalence in order to reduce costs. CONCLUSION: Considerable confusion surrounds biosimilars. Pharmacists can help resolve the confusion by explaining to lawmakers and health-system decision-makers the terminology and science of biotechnology processes and the implications for use of biotechnology products in the future.

Molecular genetics and industrial microbiology--30 years of marriage.

Thirty years ago, molecular genetics and industrial microbiology joined their hands in marriage. The event took place in Prague at the first Symposium on the Genetics of Industrial Microorganisms. My closing plenary lecture, titled "The Marriage of Genetics and Industrial Microbiology--After a long Engagement, a Bright Future," dealt with industrial uses of mutants, the lack of success with genetic recombination, control of branched and unbranched pathways and thoughts about the future, e.g., identifying the biochemical sites of beneficial mutations, exploitation of recombination and genetic means to increase production of enzymes. It is quite amazing that the Symposium was held 3 years before the advent of recombinant DNA technology. This important meeting was followed in 1976 by the first Genetics and Molecular Biology of Industrial Microorganisms (GMBIM) meeting in Orlando, all of the six subsequent GMBIM meetings being held in Bloomington, Indiana. Today, thousands of biotechnology companies are in existence making great progress in the pharmaceutical and agricultural sectors. Hundreds of new genetically engineered compounds, produced in microbial, mammalian or insect cells, are in clinical trails and many are already being marketed. The field is booming with new technologies such as transgenic animals and plants, site-directed mutagenesis, combinatorial biosynthesis, gene therapy, antisense, abzymes, high-throughput screening, monoclonal antibodies, PCR and many more. Agricultural biotechnology has made great strides but unfortunately its progress is being delayed by political controversy.

Biopharmaceutical statistics in a pharmaceutical regulated environment: past, present, and future.

The practice of statistics in the pharmaceutical industry has changed markedly over the last 25 years. This paper examines the evolution of clinical trial statistics in relationship to advances in statistical methodology and computational power as well as the changing regulatory environment. The current role of the biopharmaceutical statistician is assessed along with the drivers for future change.