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Dear all,
Drugs listed as a reference in the FDA have a mandatory clinical efficacy studies and safety ? Or Bioequivalence is enough ?
Regards,
Bernardino Silva
PHARMACIST
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Dear Sir,
Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
The reference listed drugs in FDA are the innovator products which were necessarily underwent not only clinical efficacy and safety studies (Phase I to III) but also preclinical studies before they come into market.
Bioequivalence studies are for generic drugs not for the innovator products.
Thanks & Regards,
Dr.S.Gunasakaran,MBBS,MD,
Clinical Pharmacologist & Principal Investigator,
Azidus Research Laboratories,
Chennai.
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he following message was posted to: PharmPK
Reference Listed Drug must undergo mandatory clinical trials for
efficacy and safety studies to be listed as RLD in FDA. Bioequivalence
studies are done for the generic drugs.
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The following message was posted to: PharmPK
For colors or flavors not in the IIG, indicate the compositions or
have the manufacturer fax the
composition to OGD if it is not available to the sponsor. The ANDA
drug product must be pharmaceutically equivalent to the RLD.
Differences in inactive ingredients are generally acceptable but for
more complex dosage forms you have to provide justifications for
differences in inactive ingredients. for parenteral use the excipients
must be same and in same conc. except for preservative, buffer or
antioxidant and for Ophthalmic & Otic use the same applies except for
preservative, buffer, thickening agent or tonicity adjuster. for
topical use (including aerosol & nasal solutions) it should contain
same inactive ingredients. However, an abbreviated application
may include different inactive ingredients. this is allowed the
applicant identifies and characterizes the differences and provides
information demonstrating that the differences do not affect the
safety or efficacy of the proposed drug product. Allowable changes may
require
justification by additional bioequivalence studies. For solutions,
differences in inactive ingredients may affect eligibility for
biowaivers, for eg. amount of sorbitol or mannitol in an oral
solution.
For suspensions you have to always justify differences in inactive
ingredients especially
with respect to their effect on viscosity and resuspendability.
Acceptable drug product stability is necessary for ANDA approval. For
all ANDA products, bioequivalence with the RLD can be part of the TPP.
The TPP might also include the desired drug release profile.
The specifications for the non-compendial excipient should be included
in the QOS in a tabular form and indicate method validation if
applicable. The grade used should also be indicated. Novel excipients
not previous used in may require more details including manufacture,
characterization, controls, etc. or a DMF reference and qualification
for safety. one should also discuss the use of noncompendial-non-novel
excipients with the appropriate review division prior to submitting
its application to ascertain the level of information that would be
warranted to support the use of the excipient. The additional CMC
information or a cross-reference to a DMF that provides the additional
CMC information should be included. When the specification for a
compendial excipient differs from the compendial monograph or test
results will be accepted from the
excipient manufacturer's COA, the in-house specification should be
provided. If the specification for an excipient is based on a
compendium other than an official compendium, the excipient should
still conform to the monograph in an official compendium if there is
such a monograph.
these information are to be provided in DMF. It is strongly
recommended that nonactives
selected for ANDA formula are subject to approved supplier procedures
that is similar to Active Ingredients.
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