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CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T070139Z
UID:91cc262f-0206-4636-9148-42637480233e
DTSTART:20201209T090000
DTEND:20201210T090000
CLASS:PRIVATE
DESCRIPTION:\n
Description
\n\n*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! **
*
\nREGISTER TODAY!
\n\n \
;
\n\nDrug dissolution testing is an e
ssential and critical step for appropriate and efficient product developme
nt such as tablet and capsule. A number of approaches are used to conduct
dissolution testing using different apparatuses and methods. Making a choi
ce for an appropriate apparatus and method has always been confusing and c
hallenging. This seminar will provide relevant pharmacokinetics and physio
logical background so that making this choice becomes easier and instincti
ve. No prior knowledge of pharmacokinetic and/or physiology is required\;
however\, these will be explained in very simple terms to help attendees i
n selecting or developing a dissolution method. This seminar will describe
in detail the theoretical aspect of the drug dissolution testing includin
g method development. Pros and cons of different approaches will be explai
ned in detail.
\n\nFurthermore\
, drug dissolution testing is extensively conducted to provide an estimate
/prediction of expected drug levels in humans. Commonly\, concepts of conv
olution/deconvolution and in vitro-in vivo correlation (IVIVC) are describ
ed in this respect\, unfortunately with limited success. Difficulties and
limitations of the currently suggested approaches will be highlighted. Thi
s seminar will provide details of the underlying scientific principles inv
olved in convolution\, deconvolution and IVIVC techniques with simple prac
tical examples. In this regard\, a unique and simple approach based on con
volution technique using spreadsheet software will be described.
\n\n
\nWhy you should attend:
\n\nPharmaceutical product develop
ments and assessments require extensive use of in vitro drug dissolution t
esting and convolution/deconvolution techniques for predicting plasma drug
levels. Often such testing are presented in isolation (independent to the
ir physiological link or relevance)\, however\, this seminar will train at
tendees for developing these techniques using the principles of pharmacoki
netics and physiology. The seminar will provide unique opportunity to lear
n scientifically valid drug dissolution testing and establishing plasma dr
ug levels.
\n\nIt would be an u
nmatched opportunity to learn from an internationally recognized leader of
the subject. A must attend seminar for anyone involved in product develop
ments and assessments of solid oral dosage forms!
\n\n
\nAreas Covered in the Session:\
n\nPhysiological and Pharmacokinetic Prin
ciples:
\n\n\n - Dissolution
and related physiological terms: Drug absorption\, permeation\, relevant
GI tract environment.
\n - Basi
c and required pharmacokinetic principles including terminologies such as
plasma drug concentration-time profiles/curves\, rates of absorption and e
limination\, Cmax\, Tmax\, half-life\, AUC\, apparent volume of distributi
on\, bioavailability/bioequivalence\, etc.
\n - Defining\, and differentiating\, drugs/medicines and drug
/medicinal products
\n - Defini
ng quality of drugs/medicines and drug/medicinal products.
\n <
li>Generic vs innovator'\;s products (Sim
ilarities and differences)\n
\n\nDrug Dissolution Testing:
\n\n\n - What is drug dissolution Testing and Why to conduct such te
sts?
\n - Dissolution theory\,
sink conditions and intrinsic dissolution rate
\n - Drug Dissolution Testing vs Solubility determination<
/span>
\n - Drug Dissolution vs Drug R
elease Testing - Is there a difference?
\n - Dissolution Testing Apparatus:\n
\n - Rotating basket (USP Apparatus 1)
\n - Rotating paddle (USP Apparatus 2)\n
- Reciprocating cylinder (USP Appara
tus 3)
\n - Flow-through cell
(USP Apparatus 4)
\n - Non-com
pendial (Crescent-shape)
\n
\n \n - Setting up a dissolution tester (e.g. Basket and paddle)
\n - Dissolution equipment qualif
ication (Performance Tablets vs Mechanical Calibration)
\n -
Tolerances and results Interpretation
\n
\n - Immediate release
\n - Extended release
\n -
Delayed release
\n - Current Requirements And Interpretations
\
n
\n \n - Dissolution Method Dev
elopments\n
\n - General requi
rements
\n - Selection of diss
olution medium
\n - Apparatus
and agitation rate
\n - Sampli
ng (time points &\; filtration)
\n - Acceptance criteria (Pharmacopeial\, similarity factor (F2)\, ph
ysiologically relevant\, etc.)
\n - QC method\, bio/clinical relevant methods
\n - Discriminatory vs non-discriminatory dissolution me
thods
\n - Product dependent v
s product independent Methods
\n - Dissolution method validation vs analytical (quantitation) method val
idation
\n - (Specificity\, Li
nearity/range\, Accuracy/recovery\, Precision\, Robustness)
\n
\n \n
\n\nLinking Dissoluti
on Results to Plasma Drug Levels:
\n\n\n - Concepts of convolution\, deconvolution and in vitro in viv
o correlation (IVIVC)\, their requirements and (un)suitability for predict
ing plasma drug levels
\n - Req
uirements for appropriate and relevant dissolution results
\n <
li>Convolution vs deconvolution methods whic
h one to use and why?\n - Pred
icting plasma drug levels (Linking dissolution results to physiology)
\n - Theoretical background<
/li>\n
- Converting dissolution results in
to plasma drug levels/profiles
\n - Practical application with step-by-step instructions
\n Practical hands-on interactive demonstrati
on of predicting/estimating of plasma drug levels using Excel spreadsheet
software. Attendees may use their computers as well to follow the instruct
ions for obtaining plasma drug levels.\n
\n\n
\n<
span style="color:#000000\;">Who will benefit:
\n\nAnyone working as bench chemist/analyst\, supervisor\
, managers\, director or vice president in pharmaceutical manufacturing fa
cilities\, including laboratories and associated contract organizations\,
of innovator and generic companies for human and animal products\, in the
following areas:
\n\n\n - Ph
armaceutical Development
\n - S
etting up analytical methods (pharmacopeial\, regulatory or in-house devel
oped)
\n - R &\; D\, both an
alytical and formulation
\n - P
roject Management
\n - Quality
Control
\n - Quality Assurance<
/span>
\n - Regulatory Affairs<
/li>\n
\n
\n \;
SUMMARY:Drug dissolution testing and establishing plasma drug levels in hum
ans (ntz...
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SUMMARY:Drug dissolution testing and establishing plasma drug levels in hum
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