Molecule IND Development Plan"
Learn what a typical IND plan
looks like and obtain cost estimates for each task. Read more in our
Impurities in Drug Development"
Recently the FDA has been requiring
compliance to a recent guidance on the control
of potential mutagenic substances in your synthesis or
degradation by-products. Last year TRIPHASE had 2
clients come to us on clinical hold due to this
problem. Read more about this #1 "risk
area" in our white paper...
"Top 5 CMC Reasons to Put Your program on Clinical Hold"
Stability issues and a poor
understanding of impurity profiles in your toxicology and clinical
batches is a risky proposition. Learn about the top risk areas
that put most Biotechs on clinical hold...
"Drug Development Strategies- QbD Approaches
for Pre-formulation and Formulation"
Learn the most current
thinking and learn about a typical small drug development
program key quality considerations for preformulation and
"Regulatory Starting Materials- A Case Study for the
Virtual Drug Company"
Learn the most current
thinking at the FDA about the selection and justification of regulatory starting materials
for API. A review of the regulatory guidance history as
Q11 is provided followed by a case study which includes
actual FDA comments back on the selection of RSMs from a
recent pre-IND submission...
for Outsourcing Carry Special Risks"
Food & Drug Letter, 24 April 2009 Vol. , No. 819
Learn the FDA's most current
thinking about small Biotech's and outsourcing.
Learn their expectations before you run into trouble. Read more in our
know that FDA Letters are often a precursor to a Guidance which
is a precursor to law???
and Scientific Advice Meetings"
Let TRIPHASE take your complex chemistry and summarize
in a concise well-written summary for a Pre-IND or
Scientific Advice meeting package. Read more in our white
Q3D Case Study"
ICH Q3D “Elemental Impurities” became the official
guidance in September 2015 governing heavy metals and
catalyst impurities in drugs for the European Union,
Japan, and the United States. Prior to ICH Q3D the “official”
Guidance was USP <231>. Now that ICH Q3D is official
it should be the first choice for the setting of
specifications for metal limits in drug substance and drug
product. As our case study illustrates, ICH Q3D
allows for higher levels of metals based on projected
daily dose in grams of drug product than possible under
ICH <231> which is fixed at 10 ppm per metal or 20
ppm total. Read more in our white
Studies- GMP or non-GMP?"
This white paper addresses the cost - benefit
considerations in using either non-GMP or GMP drug
substance and/or formulated drug product (test article) in
your GLP studies. Three different batch matrix options are
presented comparing the cost, time, and risk. Key words
are test article GLPs, non-GMP vs. GMP manufacture, GLP
testing, impurity tracking, CDMO report deliverables
required to populate IND Module 3 pertinent to drug
substance and drug product used in your GLP and proposed
is Driving the Manufacture of Drug Products Outside the
This is an important review by www.FDALAWBLOG.Net
of the law governing the manufacture of clinical drug
substance overseas planned for import for USA based manufacture
of the clinical drug product at the pre-IND stage. In
short, drug substances (APIs) can not be manufactured
overseas then imported and formulated into clinical
supplies in the USA without an open IND. One usually
does not file an IND without the drug product
manufacturing and release information in Module 3 but if
you can't ship API to be formulated w/o an open IND how
does one deal with this dilemma? Your overseas API
CRO may not be as transparent here as you would like. Feel
free to contact us to discuss this issue in detail and
hear options available to circumvent and / or comply with