Passive processes for thermal energy storage have received a lot of
attention in the past 25 years. These passive thermal energy storage
materials can typically be divided into two parts, specific and latent.
This paper will primarily focus on the...
A significant body of scientific and regulatory knowledge has been
accumulated over the past two decades regarding “leachables”
in various drug product types and dosage forms.
From my perspective, it appears many companies are paying
more attention to value or getting the most service for invested
dollars
Moving Clinical Development to emerging countries could
provide advantages to R&D companies. The availability of
trial- naïve patients and often treatment-naïve patients together
with less competition for enrollment, high quality of investigators ...
JHP Pharmaceuticals is not a very familiar name in contract manufacturing.
Have you been at this a long time?
This case study summarizes the expedient formulation approach taken
to enable Phase I clinical trials of a new chemical entity (NCE) of a
class known to have poor oral bioavailability in pre-clinical species.
MA:
The large companies with excess capacity are shedding that
capacity and looking for right-sized manufacturing. Drug
pipelines are inconsistent and it’s expensive to maintain idle capacity
for a pipeline that may or may not mature in the near ...
The economic downturn of 2008 interrupted the growth of fuel
prices. In 2010 the fuel prices grew slowly. The future challenge
is how to deal with fuel price increases.
While GMP for clinical supply manufacture is written vaguely and
“interpretable,” at least there are long established guidelines,
both formal (e.g., Code of Federal Regulations,
International Conference on Harmonization) and informal
(e.g., Gold ...
The elements are in place for a perfect storm to send clinical development
costs skyrocketing even higher.