This document discusses the key stages of pharmaceutical preformulation and formulation development. It begins with an introduction and overview of the product development cycle. It then covers topics like candidate drug selection, pharmacological characterization, biopharmaceutical considerations, early drug development and product design, product optimization, and post-optimization activities. For each stage, it provides brief explanations of the goals, studies, and factors considered. The overall summary is that this document outlines the major steps involved in taking a new drug candidate through preclinical testing and formulation optimization to become a developed pharmaceutical product ready for clinical trials and commercialization.
‘Targeted drug delivery system is a special form of drug delivery system where the medicament is selectively targeted or delivered only to its site of action or absorption and not to the non-target organs or tissues or cells.’
Bioavailability & Bioequivalence Studies
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Sub :- Research Methodology
M.Phrmacy Semister 1
Savitribai Phule Pune University
Bioavailability:
Bioavailability is defined as a measure, of the rate and amount of drug, which reaches the systemic circulation unchanged following the administration of a dosage form.
Absolute bioavailability:
When systemic availability of a drug administered orally
is determined in comparison to its I.V. administration, denoted by F.
Relative bioavailability:
When systemic availability of a drug after oral administration is
Compared with that of oral standard of the same drug
( Solution or suspension ) and denoted by Fr.
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
‘Targeted drug delivery system is a special form of drug delivery system where the medicament is selectively targeted or delivered only to its site of action or absorption and not to the non-target organs or tissues or cells.’
Bioavailability & Bioequivalence Studies
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Research Methodology
M.Phrmacy Semister 1
Savitribai Phule Pune University
Bioavailability:
Bioavailability is defined as a measure, of the rate and amount of drug, which reaches the systemic circulation unchanged following the administration of a dosage form.
Absolute bioavailability:
When systemic availability of a drug administered orally
is determined in comparison to its I.V. administration, denoted by F.
Relative bioavailability:
When systemic availability of a drug after oral administration is
Compared with that of oral standard of the same drug
( Solution or suspension ) and denoted by Fr.
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
BIOPHARMACEUTIC CONSIDERATIONS IN DRUG PRODUCT DESIGNN Anusha
BIOPHARMACEUTICS studies the in vitro impact of physicochemical properties of drugs and drug products on delivery to body under normal or pathologic conditions.
Biopharmaceutics links the physical and chemical properties of drug and drug product to their performance, in vivo.
The aim of biopharmaceutics is to adjust the delivery of drug from drug products in such a manner as to provide: optimal therapeutic activity and safety for the patient.
United State Pharmacopoeia (USP) The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definition IVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
SUSTAINED RELEASE (SR) & CONTROL RELEASE.pptxRAHUL PAL
Sustained-release medications are usually labeled with “SR” at the end of their name. These medications prolong the medication's release from a tablet or capsule so that you'll get the medication's benefits over a longer period of time.
CR = controlled release, SR = sustained release, ER = extended release, IR = immediate release. *
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
Plasma Drug Concentration Time Profile
Pharmacokinetic Parameter
Pharmacodynamic Parameter
Zero, First Order & Mixed Order Kinetic
Rates & Order Of Kinetics
Pharmacokinetic Models
Application Of Pharmacokinetic
Warm Greetings from Chempro Pharma! Here is a brief presentation regarding our newest project/service offering - pharmaceutical product development. We have a highly specialized team that has worked with the likes of Novartis, Merck and many more market leaders within the pharmaceutical industry. Feel free to review this attachment and contact us at pharma@chemprogroup.net if you have any questions, thanks!
BIOPHARMACEUTIC CONSIDERATIONS IN DRUG PRODUCT DESIGNN Anusha
BIOPHARMACEUTICS studies the in vitro impact of physicochemical properties of drugs and drug products on delivery to body under normal or pathologic conditions.
Biopharmaceutics links the physical and chemical properties of drug and drug product to their performance, in vivo.
The aim of biopharmaceutics is to adjust the delivery of drug from drug products in such a manner as to provide: optimal therapeutic activity and safety for the patient.
United State Pharmacopoeia (USP) The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definition IVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
SUSTAINED RELEASE (SR) & CONTROL RELEASE.pptxRAHUL PAL
Sustained-release medications are usually labeled with “SR” at the end of their name. These medications prolong the medication's release from a tablet or capsule so that you'll get the medication's benefits over a longer period of time.
CR = controlled release, SR = sustained release, ER = extended release, IR = immediate release. *
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
Plasma Drug Concentration Time Profile
Pharmacokinetic Parameter
Pharmacodynamic Parameter
Zero, First Order & Mixed Order Kinetic
Rates & Order Of Kinetics
Pharmacokinetic Models
Application Of Pharmacokinetic
Warm Greetings from Chempro Pharma! Here is a brief presentation regarding our newest project/service offering - pharmaceutical product development. We have a highly specialized team that has worked with the likes of Novartis, Merck and many more market leaders within the pharmaceutical industry. Feel free to review this attachment and contact us at pharma@chemprogroup.net if you have any questions, thanks!
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
Biosimilar CMC Analytical Master Files & Development SolutionsCovance
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
Review Article: PROCESS ANALYTICAL TECHNOLOGY- Innovative pharmaceutical deve...Vignan University
Process Analytical Technology in pharmaceutical production checks the quality of the raw material attributes
both physically and chemically, that too off-line, in-line or on-line. Process analytical technologies have been
applied to manufacturing processes for decades. PAT is a system for design, analysis, and control of
manufacturing processes, 1
based on continuous monitoring/rapid measurements of critical quality and
performance attributes of raw material, intermediates and products. PAT involves measurement science by
using conventional process sensors such as pressure, temperature and probes. The PAT initiative was initially
intended for traditional pharmaceutical manufacturers, but the FDA.s, PAT guidance now clearly states that it
applies to all manufacturers of human and veterinary drug products. PAT involves shift from testing the quality
to building quality into products by testing at several intermediate steps. It specifically requires that
quantifiable, causal, and predictive relationships be established among the raw materials. There by decreasing
the chances of contamination and cross contamination. It also saves a huge amount of time and money required
for sampling and analysis of the products. Overall PAT paves a way for producing a quality product thus
satisfying the customer needs and creating a good brand image for the organization. PAT that will encourage
the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and
quality assurance as well as novel analyzer technologies.
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
Four Stage Drug Development Scale Up Studies and Commercialization.
pre-formulation ,prototype dev, biological aspect , scale up and commercialization.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
2. Flow of seminar
Introduction
Candidate drug selection
Pharmacological characterization
Early of candidate drug selection
Biopharmaceutical consideration
Early drug development and product design
Product optimization
Post product optimization
conclusion
3. Introduction
To be successful and competitive, research based pharmaceutical companies
must ensure that new discoveries are frequently brought to the market to
generate cash flow. This is required to find the next generation compounds, to
meet the therapeutic needs of patients and of course, to benefit the
shareholders. This cycle of events is sometimes referred to as Product Life
Cycle.
Unsuccessful compounds should be removed at R&D level only to minimise
expenses of clinical research.
In spite of high risk and high cost involved, there is still a huge incentive for
pharmaceutical companies to seek financial rewards such as “blockbuster”(I
billion US$ per year).
Hence the importance of accelerating and optimizing drug discovery and
development, and getting to the market first with a new therapeutic class
medicinal product, cannot be underestimated.
4.
5. To avoid backtracking along the way with long life years
investments a forward planning should provide opportunity for a
well throughout and efficient approach to product development
• Product design
• Process design
• Product optimization
• Process optimization
• Scale up
• Clinical trials
• Scale up for commercial production
• Process validation
The development
process can be
broken down into
several key
defined stages
such as
6. Rational for work
For successful
product
development which
is often associated
with
Good team work
Multidisciplinary
process
By in to the plansStrategies
Descisions
Project
management
system
7. Candidate drug selection
Depending on potency, specificity, duration, safety and pharmaceutical aspects candidate drugs are nominated
for development after being passed through “combinatorial chemistry” and automated “high throughput
screenings”. To ease this burden some rational drug design and quantitative structure activity relationships
(QSAR) are often introduced. Representative libraries of compounds are also present along with genomics.
During CD selection molecular lead is optimized by testing in vitro and in vivo studies with range of
compounds.
15. Most commonly used
classes of enhancers to
drug absorption from the
GIT
NSAIDs
SURFECTANTS
BILE SALTS
MEDIUM CHAIN FATTY ACIDS
MEDIUM CHAIN GLYCERIDES
ENAMINES
MIXED MICELLES
EDTA
PHENOTHIAZINES
LIPOSOMES
AZONE
FATTY ACID DERIVATIVE OF
CARNITINE AND PEPTIDES
SAPONINS
CONCANAVALIN A
PHOSPHATE AND PHOSPHONATE
DERIVATIVE
POLY ACRYLIC ACID
To increase bioavailability we need to increase solubility of the
drug if not the intrinsic solubility but the dependent ones and
further increasing the permeability across the physiological
membrane barrier by incorporating suitable enhancers in the
formulation of by preparing certain delivery systems
16. Biopharmaceutical support in
candidate drug selection
Dissolution,
solubility
affects
absorption
of the drug
Distribution
Degradation
and
metabolism
Models for
study
Computational
method
Partitioning
between oil
and water
Cell
cultures
Membrane
vesicles
Intestinal
rings or
sacs
Excised
segments
from
animals
using
suitable
chamber
In vitro and
in situ
intestinal
perfusions
In vivo
cannulated
or
fistulated
animals
and
In vivo
gavaged
animals
17. Early Drug Development and product
design
To provide clear direction and objectives for the project team
To gain bye in and input from all key functions at the start of development
To asses the feasibility of the project in commercial and technical terms
To identify any risks early and hence manage them
To avoid wasting valuable resources on developing a product that is not needed or wanted
To provide a good reference source for the development plan
24. Conclusion
These product optimization is done for solid
state only. For parenteral, ophthalmic,
inhalational and oral different formulation
excipients are taken into account.
