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Generic Drug Development Process 2

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Tanmay ravindra Chaudhari
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32 views15 pages

Generic Drug Development Process 2

Uploaded by

Tanmay ravindra Chaudhari
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Generic Drug Product Development

By:-
Iti Chauhan
Asst. Professor
GENERIC DRUGS

DEFINITION- A generic drug product is essentially identical to


the brand name(reference) drug product in terms of active
ingredient, dosage form ,route of administration,
quality ,safety, efficacy, performance characteristics and
therapeutic indication.
● EX- PHENYTOIN is the generic drug and DILANTIN is the
brand name for the same drug.
● Brand drugs are the drugs which are protected by the
patent.

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• The manufacture of generic drug products must make provision
for market competition and lower prices for the consumer.

• Generic medicines should be more affordable and accessible to


the wider population.

• Generic drug product availability influences the innovator drug


product manufacturer to develop new drug products that have
improved efficacy and/or safety features.

• Generic drug product manufacturers must formulate a drug


product that will have the same therapeutic efficacy, safety,
and performance characteristics as its brand name counterpart.
• Generic drug products cannot be ‘‘superior’’ or ‘‘better’’ than the
brand name drug product.

• A generic drug manufacturer may have to use the same or


similar inactive ingredients or excipients as in the brand
formulation.

• Generic Drug User Fee Amendment of 2012 (GDUFA) is


designed to speed the delivery of safe and effective generic
drugs to the public and reduce costs to the industry
Selection of a generic drug for manufacture

● The main driving force for the selection of generic drug


products for manufacture is the estimated sales volume
for the branded product.
● and the potential market share that the firm expects to
have once the generic drug product is manufactured and
approved for marketing.
● In addition to the expiration date of the patent for the
active ingredient, the generic firm must consider any
other patent claims and exclusivities that the innovator
firm has filed.

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The generic drug manufacturer needs to consider:
● The lead time that is needed to make the product and
submission of an Abbreviated New Drug Application
(ANDA) to the USFDA for approval.

● There is a financial incentive to being the first


generic drug product filed and approved by FDA.

● 180-days exclusivity, is given under certain conditions,


for the generic manufacturer who is to file first.

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•The availability of technology and the cost of acquiring
technology will also impact the choice of generic drug.

Formulation considerations for generic drugs include:

● The availability of raw materials, chemical purity,


polymorphic form, particle size of the active
pharmaceutical ingredient.
● Any patents that the innovator company has filed,
including patents for the synthesis of the active
pharmaceutical ingredient and composition of the
dosage form.
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GENERIC DRUG APPROVAL PROCESS

● The FDA’s Office of Generic Drugs is responsible for


reviewing the ANDA and approving the drug product for
marketing.

● Website https://www.fda.gov -
✓ provides additional information for manufacturers of generic
drug products that includes a flow chart presentation of the
ANDA review process.
✓ describes how FDA determines the quality, safety, and efficacy
of generic drug products prior to their approval for marketing.

● Generic drug application reviewers focus on bioequivalence


data, chemistry and manufacture quality, microbiology data
where relevant, requests for plant inspection, and drug
labelling information. 9
• There is a requirement for in-vitro dissolution and in-vivo bio-
availability and bio-equivalence (BA-BE) testing of the new brand
(i.e generic manufacturer) which compares the release of active
pharmaceutical ingredient (API) on certain dissolution and liberation
characteristics and pharmacokinetic parameters (Cmax, Tmax, and
area-under-the-curve) with those from a reference standard.

● Generic drug sponsors do not have to perform the nonclinical animal toxicity
studies or expensive clinical efficacy and safety studies that are included in
the new drug application.

● FDA’s Center for drug evaluation and research provide for the review
and ultimate approval for marketing a generic drug product.
Generic Development Process

Mission Concept
Product Planning
statement development

Testing System level


Design detail
refinement design

Production ramp-
Product launch
up
Mission Statement
identifies the target market for the product, provides a basic
functional description of the product and specifies the business goals
of the effort
Concept development
The need of the target market is identified, alternative
product concepts are generated and evaluated, and a single
concept is selected for further development.

System-level design
● It includes the definition of the product into subsystems
and components.
● The final assembly scheme for the production system is defined.

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Detail design
● Includes the complete specifications of the geometry,
materials and tolerances of all the unique parts in the
product and the identification of all the standards parts
to be purchased from suppliers.
● A process plan is established and tooling is designed
for each part to be fabricated within the production
system.

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Testing and Refinement
● It involves the construction and evaluation of multiple
pre-production version of the product.
● Early prototypes are usually built with production
intent parts(parts with same geometry and material
properties as intended for the production version of
the product).
● Early prototypes are tested to determine whether the
product will work as designed and whether it satisfies
customers needs.

The goal of prototypes are usually used to


answer questions about performance and reliability in
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order to identify changes for the final product.
Production Ramp up

The purpose is to train the work force and to work out any
remaining problems in the production process.

● The artifacts produced during production ramp up are


sometimes supplied to the preferred customer and are
carefully evaluated to identify any remaining flaws.

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