Amer Alghabban
Outsourcing used to be done for mostly “non-critical products/services,” but the last 20 years have seen a reversal in this trend. More and
more companies are outsourcing key critical Good X Practices (GxP)-regulated clinical processes and products manufacturing.
Jilla K. Boulas, MS
The development of a drug product is a long and costly journey which starts from basic research and moves down a path that requires much
development, and takes turns at points where decisions have to be made. At the end of this path, one hopes to arrive at a safe and effective product for the treatment or prevention of a disease or condition.
David P. Elder, Ph.D., Christoph Saal, PhD
Lipinski’s seminal paper on experimental and computational (in silico) methods to estimate the solubility and permeability of drug candidates
was published in 1997. The iconic “Rule of 5” predicted that absorption was adversely impacted when the calculated LogP (cLogP) was >5,
when molecular weight (MW) was >500, when there are >5 H-bond donors or >10 H-bond acceptors.
Dennis Jenke, Ph.D., Barrett E. Rabinow, Molly Chacko
Extraneous impurities in a drug product do not provide a therapeutic benefit to the product’s user and could adversely impact the safety and/or efficacy of the drug product. An important set of impurities
(known as elemental impurities) are those entities, organic or inorganic, whose chemical formulae include elements from the following series
in the periodic table: transition metals, metalloids, other metals, and lanthanides and actinides.
Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) for the third quarter 2014 (July through September 2014). In this quarter, FDA approved 38 NDAs.
J. Michael Maher, MS, MBA
Successful companies are customer-focused, and in the research-based pharmaceutical industry, patients are the key customer. The biopharmaceutical industry is unique in many ways, however, with
attributes that complicate the straightforward consumer-provider relationship enjoyed by many other businesses.
Eduardo F. Motti, M.D.
Many readers may agree that Brazil is the country of soccer (until its recent loss to Germany by 7 to 1 in the 2014 World Cup). Brazil's famous association
with soccer galvanized after it won the 1958 World Cup in Sweden and introduced 2 phenomenal players: Pelé and Garrincha. The latter did not
become as internationally famous as Pelé, but he was a soccer genius, too, in spite of several significant physical and intellectual limitations.
Lea Studer
Contract manufacturing is playing an increasingly important role in the strategic approach companies ranging from big pharma to specialized biotech take in producing products for sale.