UNIT 1 New drug discovery and development PRS(anuj sahu)

Bpharmacy 8 semester pharmaceutical Regulatory science bp804T

Unit I
New Drug Discovery and development
Stages of drug discovery,
Drug development process,
pre-cinical studies,
non-clinical activities,
clinical studies,
Innovator and generics,
Concept of generics,
Generic drug product development.

1. & mg Discovery
{ Development fncess
Pre clinical studied N
Non-clinical Activities |

[stages

Clinico) studies

Innovetor and genoucs

Concept _of genenica-

nenedc Drug. Product Development .

Y ==

2. at
> Mi

= NEW_PRUVI DISCOVERY & DEUELO

at

which 6 Herpruticalyy useful in cuming and |

a Disense .

| is process muoles the identification cf candidates, |
synthesis, Charactvization,_veidation optimization « —.

| sucening & Assays — for therapeutic Aha. >

& Cou + [smog fae mer,

Any shencspeutic Sie act of.
Active substance Anaing. «Something —
ue CAPI) ka LE
—+ cong 4) Y
|| Mea y na process must be continued

tou stages
= y

In omar to make a medicine et
eiecive and hos oppmed aM Real
| Requirement.

Tr takes about LE yen sl From discovery tone

| appved medicines . —
21 Me Drug déve and Oueiopment mi —
time — consuming costly Bas won
Commercial Risk. = ne
re en be
24 on uion molecule
an an owegge, A mi are. arr

seer

3. —— 8 ]——— _dinical Reena Y

o =
A =
Ag > Drug Discover +
© [weed =
tee [weed]

Loro effica Teatment $ |] -
of medicinas 7 Neo Diseases IK

Need dor

discov
To Redue - = a a u
_side dkds oF a
‘Dru
ña To Reduce. 1
= he cost 4
or thenapy à

—+ [omg Desckpment| + Me enfire pré

@
a na covered
— ringing a3 Oe taking Neely discov
Sew ca o
to e

. TR Regal
Wang ef! OR Re \pprovel_ +0
| of maken aut oy

%

| _

4. pevelopment-

Agr png Development fes.

“AB [staves Lor (Run OxseneRt) AND u u
O get ¡dentificadion - =
Vo Tanget _ validation
Dead _Umtifiatim.-
O_tead optimization:
O Product cacti

5. STAWES OF DR
DISCOVERY
a [Targa identi cation) > Me Art skp in

the Drug Pisevery is identificas
D ve is identifica
d the Biological ovigin ot Disease z

y
And the potential tage For ‘miewention

+: In vito Reemch studies Are pedorm +

Identity the tag u
a In sage iaenihadion ‘densify e (sense)
= ET
T causes | ag Bd
Reason behind he Pextticattan organ.
a ade ae
Disease

> The Target con be a gene, protein,
nucleic Aad , Any organ etc
ee ig ¿e
(axget identification) —? ligand Se
ee > pharmacophore
“= QsAR is
Based
Ugand es
| > Docking, ¿0 fsodiation
PApproaches + vt sarge ee.
> Lurctional
Sen

7 21

6. Now Mm Hus skp y
nalysed à vodidale .
is a Process: Y

O [Tage fon
a © fi
> Target identification
y i
which we Pete tat age
gene, Protein. 15 Actuel my
in Disease poets
2 Binding of Prig to the target ls
dikely to have a auatve ect.
> In Target validation {he Pevelepet tar
target and confi its Role im Disease.
> Abo check Ane “Pagani

E
m
p such ab
a
5
4
>
\
1

® [read identification lead Compounds axe
the one which have desirable ph'ologica)
2 therapeutic effect

> In his SP identifica the Drugs tha
6 aduatly used to (wie that disease
dead compound)

+ Dr can be synthesized ‘in laboratory

> entfiel Mat Prygs which have potent

to Sind to tne identified get suc

=> Ppprok S000- (00 Compound Should Se.
Choosen .

7. PM owns: o (eal ana
= ei

© AR Defined On“
à Ta
© mug Abiuty. a
O Syndic feasbiuty
v conformation sckens and
will identify lead Gmpoui Fi Liens

Gunes) OF lead compound —
| —O natura! > Plant, Animal,

Source y
= für ovganism -

© chemical

— tource — chemical molecules

Medicine] Compused Based
Dig discovery &
= pesigning
Lead mizefion —
@ [end _optinientem = sex. entfcation
lead compound optimize Te
y
modi Compounds for ‘merase
& sa
| > be in be optimized through various
methods —
—functional group modification -
— SAR -
— QSAR.

> Approx
mals»

© computaho
Chemi

{Ss ehlkaliveness

8. N

> Tre Pharmacekmeltc , Pleodynamics 2
Ame Properties} Studies-
v

are integral Pest of tead optimiza
> In led optimization ves Pote, Siding
2 pl kinetic pwpertics of png & pe A
toiaty |

© [did denadtoizatimo—
when A

pag hove a tmeapeuhc Aci ES

Au an be ananacknzed 84 ts
Caza, Shape|, engin Twenknes) Applets
sl 2 logia Achity),

9. Drug Development

|
Me

Loew osueopment] process — INCLUDES +

a
Emulation and_Development >
Pharmaceutical
mutation is a stage of Drag _ Pevelopmenk
un
In which the Physicochemical _ Properties a
APL _is_chanactenize.“ Prduce a fioavaibbe,
Stable & optimal Dosage. firm.
y

i ma specific Adminishation Route
O. Reformutetion

—uametos — . solubitity.
> en of AI
Sold State Properties Mm
Controlled Rélese
"optimization of Petite Sree
existing Pormulbchiens. 5
y IN

10. — [re
D Tita Tigh = 1 hy Catt —

Process the Preclinical _veseanch

invclves -
v AZ E

7 @aluadtion of pmg's [safety land Eficag Jin,
| Animal species" that | @nctude to expected

human outcomes

>, Te pr clinical trials also have to need

Approval 6y comeA ponding, _2ejutecuny Patong >

Gifs’ comune Med tros

4 ante donate rl |

— _|fe-cinical| - |

2 i a > füial) |

scores Con Animals) Trees | Chumans)

aa (es

iais can be @mducted tn

21 The pre ctinical

| ae ===
+ fmeneral = |
[Prema | Cale.
z Te goxielogical — !
Dr Denis with. Pcopinetics studies can be
£ _Miodnamic Panametos Performed 84.
of om. en +
i gave In vive
Penes > [A) Absoration- 3%
== (p) pistibution NAAA E
m) metabousm dona eheer of
(E) elimination ony

= ”
Ted oh og in Body".

fé
de
BT

11. In Mis process he pm
_Denelopen must he matiza] New

application fon)
Pug im

Before __@mmencement _ clinical
ey _ to start “he human Clinica}
als.

ace Brcctinical HP, Clinical dia
ais y (Phase 0,1,2,5,4)
Submitted ——
do FDA
2 the amp Appiicectiion , Developer must _imetule :-
T Recinical & tonicity study pate
T_ my menucfacning _mfomation

Clinica] Research] /— (als)
Mest_ an those —

Research studies or Trias in which vee pal
tat a Medicines / Dug 1

‚Swigical or:
Otho medical events
y

ma humans
Am eh Ainical tial is te
tota New Areatment Z
cate safe & ive Be
fae. 4

12. ones Fa
[fue o) es

wsalety _-Pugation

u =
first tal 2Saicty
on human: HDi 4 saver!

ost > one
Duration — several ne dl

moniter = Genki

joe A TO =

S piven
Pride infos ino cima “Seat ous
on dosing & Roë à Bug check MO

it ilot wich pose
‘ath, human 1s, Best
= che,
‚ehrechveness +

LA vey = Pose of Pug 15 given to

abad to -15 Pe
Me main Rotpose “hie pue e de, (een how
is processed in the oy ono _ how.
Read with in the Baty -

13. di)

>

0)

=

3

‘WwW

@

[pue = 1] > In this pase, mg ig

all em. 20-80 healthy Volcan

> The main purpose is check te
and side effect toiity ef the Drug
After Phase 4, Studies Almost [407]
of Dregs travel to the Net phase |

Phase —2 | > In «his phase, Drug is eed

ON Apprex co - Soc Patients
y

With their _taxyeled Disease
Te main purpose is to check te ba,
& side efect of Prugs
Around B37 1 of ugs travel to the nat
Phase Ñ

[prase=31 > In His phase, Drug. is tskd m.
appPrA 1000 -S000 Rafients. “with ganged -
disease . 5

The Main Punpose js to check long. eum. sabe.
tolonbiúty of sde effects , Prug © interaction.

Si 4 May.

Te phase -3 “Watuate how the new medial?

. works iN comparison to existing medicahon

Tor _ same condition,

= Aer pase 3 pg is undengees for the

apprvel of FDA, 7 After apprval mug is 3

lues in P Marge, Gntey in med #
Kate) À

14. I [Phase=4) — ;
4 4 host market —
Cy ng a
An Ms oi 5
¡obte a A)
Pata is collected” About FE M_ market the

| Sats or not ig that mg is
a] iF au ok
Recall it rom

Z| Lote) > For Appmal Mrs — _

Rectinical stusies

= sb 100
Glinical thal) Phase 2 E
> [nase u
Phase “I Pos
4 NDA 1 =

Phase IL > fpA_ apprval Punt

LT New Dr Application | PA) > =
2 9 Te NOA is a formal ___—

Anal step a Dg Developer takes
a &
n_which _helshe apply to te nd. :
‘ Ong Administration. to ge apprval
mauceting a New Drug.

a
Alter Phase 3 trial NDAS submi

15. Jn__wOA ne Developer must inane

Proposed labeling ~~
safety update. 7
2 Drug Abuse information.
_ Patent info.“

HA TEA Rai] > once. fon oblein_A mpeg
ADA hen FEN FDA am Review.

Ags NDA
AR send

FDA / pea PET =

L
FDA Review team. Decide

J
: a NDA ‘a net
SF RDA is compleale. complete. Raian
Reiiao team has 6 tp GN Reuse to Nie He.
Lo_months NDA v
o 3

ur 4o_make Deion. on whether.

a o app Py gy _

‘i ab =

i ——fach_member_of genero term. Conduct a All

of his Shen section of Apprication.. -

Ed Tre
E Tpetion_À FDA inspector to ini
—+ Sees

== de

16. 5 Recinical studies is a laboratory teat for |

ses a or Naw medical” _Pevies-

which is Lai Done _ on "Animal as
do sal Se if the hoped fir treatment |
words and if is safe to dest ón humans.

O > puni ya > Ainice] i
ES, no Cn Anima)

De Prdinical studies ane begin before clinical

5 als = = -
Recimical tesecerch inctude Tsyatheiisl, MBurdlication| &

Ténimal — esting) Wien Is done to measure he Biological, |
Activity E Safety of an Anvestigational eng. |

7 fiectinical Research 5 conducted 84 ‘Pharmaceutical |
CT au
Development - |
2 freclimical studies on Animals ane dene to:
Determine important information mctuding “—

o Merapeutic effect —
= Potential side = A

toxicité * nf

1 _ meta olsm E
A desrance… of Dg in te Body.

aus)

_ Delermne a Ongi Prineñc 8 Páymamic |

A tort Anrough Animal eig.

17. BD Tip) of fecinical studies —

En >

y in
N ” . €
? Perform = Perforn a ving.
Compute By Procedure Organ
nee pa, M A mic >
PR environment uE ne A
i :
QI outside the Living Bente
oxganism

D [non cine Activities | (or prectinical)
>. The Non cinical activities] study is bene.

Ÿ 5
In order to sunvey the safety le,
O pam vokinetic & Moieineic chanadendis
L of therapeutic Subiances . Long)

FTF the non clinical or preclinical studies
improvement + is Performed weu , it. can envie
E Ane chances oF sucess im the.

- y
= Clinical _Pevelopmerit Phase -

> Non clinical Adivities pone m Animal gy

species | e |

18. 1 © check the ph"
Lm Man as in Ani
| © Toxic effect in

man -

Reason toting he non cli any À

mate!

cologeiíal — effect ane same. |
mal

species will Redic ADRS m. |

[O © control RAR assesment-

Fal ‘Acc: t mp” won ¢

Antica} studies explain, About».

O sakety pharmacology

© Pramackmetics
= D P'codymamics:
| © wenenal nile,

O inendwäcty

> Tie man Am

© _ caninegenicity __

33 -
© recat Tolerance

ot nn clinical clon, Es _
a

— to Wentify Potencial Png due greatest es
— d SUCEAS +
ee a
F1 [clinic] studies | 7 Already Piscussed in
y et mg Denelopment Process .
| y
2 point =D

19. => Me mar product my
new chemical entity. (AD)

ab =
which has Received. a "patent" om roy
= | chemical formulation or mecnucachring
— Process . In y
7] T4 obtam _ Approval Regulatory Authority >
an alter ertensivc — seating. te ar
And is sch under a Brand Name

a> =

1 His _Adwatly a Product for _ which
| — LSakty) + ha have Been fly
E established

D ¿ames > > =
Ten IT A generic Drug is made de. |
a Same Active ingredient as fts © innova,
pra
2} mn am words, "Ihe pranmacological Cd
$ a generic 0muy is _exactty de - Same
as: _innaatur Ds —|

olor Companies can manufacture the genic
bl rugs unen patent of ‘mmovakor Mmg-——
expires: |
2, neetc DA ae Cheap as hé soak
| gie ne on: to. Demonstrate. ;

ME Quality, Sadety & ein dy
through A ae is pa

20. (ER

Fe Similmuties
Between See u
> = Tonovactor _

Sch Di > =
[sheng]

= |

AN

==
SE

gunda tit of imevat À generic Pig

save qui] — Immoahr- Veneic |

Product Product” |

Rani ádine HC! zantac Camy | Intec Cows

mefanamic Ped fonstan (Pre | Mefetab Prime |.

D | pimxicam Feldene Pfizer) | Apo Pivaticam. |
I Capoten)

> Ca bition Fra) Ar

ON september 24, 084, if 38H us congas
the Het warman ft was std. — |

Ac west en cage the.
prarmaceutical

he objective of this
manufa during af geneic Drugs 2

Industries 4

4 to establish he _modean_ysien-

a tuition
È A

Cf go

21. The Requirement to apProve he _genenic m
usas 4p Submit an Abbreviate! pa E
Application. cue

E By the Pharmaceutical companies to he
= Regutatony _Authories for_hetting the Appa
L to maketa gacic Dg.

C= meneic are. formulated , peveloped , & manufeu;
I 8y other Companies when Patent 2 other.

= exclusive Rignt of Bründed png have

L rapid. .

E = As geneuc Ong development does not require

. lange investment for Dwg discovery, and

L Recúnical 4 dinical tials

E >, My ac available at oe.
0 ee
© lac. to whol >,
Generic Drug is a premacade

Product which is usually intended to Be
= interchangeble with an “ imovator product"
L= y
— PLD is manudactued with 4 license from.

Es innovator _ comp. z
2 And 5 a After erpirayı Date oF
Patent, ”

— FM gmeic parmaceutic product, more is "2
lq standard categorization .

Tus ee Generic ” product (an be

22. existing predict Registral

launched, & f u,

maßketed in a | Ar wa i
New market company L hr

- ER { ne ma

Ol A generic Dmg is _ Approvect_ ey the
—Regalatory Agena Er i=

D _pranmaceutiauy equivalent

Contain identical Amount of the Same Active. —
valient in same me fm € Rate À —
Administration ı —
mects applicable _ stantand of shiength ., Quauty ,

at
| Boequivalent =

01734 “dod not _prsent a En Or penta) — eer
— |" foequvatence Prblem 4 it meets an a
E in wibo standard —_C Dissoluhon sesting)

potential E
E it does pret m3, a AO

>— | Bicequivalence Prem tt
TT |

23. appnpiekt —
‘Adequate labeling.
Manutaciued in.

a [Brand
oo Ne Difference. [APL | wo Différence
© tigre in Pace] lower in dat
wos (cheap).
__® covered if no Tnswrance | 3
generic om coverage | Nomaty flog
exists” covered =
© | Ton and approves [active] pike BE
8y FDA Lingrecient | Prven_ to 8
=> Acceptable by ne! 2
® no dame. (SMS No neue
{Dose J |
= Ds aie sonde Apparence | _ Packagid
|} maire je
—— XS clown 9
Packaging 2% — 3

=

_Boequivalence standard.
USAN = Lunited state Ati
pa > Ann: => (internation) Non

compliance th

camp

u vs fueneic us]

I

24. + [urenoúc Drug Product Developme | ,

[uenode | + 4 Prduch |
(pry, ) Development)
me Process of Developing.
neo Praxmaceuhe dys
Anar we Ultimately. Smugh.
E = to ne make.
z Me cbjechve A veneúc On
Product Development 15 +0 pevelop a [stable]
2 (Bioequivalent generic Product wrth
peñrarke Prpedies

25. Product Development is a Katie
Mat ums a

ST —

| and mutidisciplnaig. PS

= techno logical m

_ Ana a manket opportunity in prduds
with economic prt for the company.

The objective of generic duc _developng:
ie ee a atl Dee

_ gaeûc pag product with Desrable _ Prepexties

>: Te Process af Development include [three |

7 Gequenñial stages]. essential br sucesful gene.
ong development .

D. hescvcogment stage >. Lt involue cenectig §

evattating Data - and information
Me — Related to pu.
a Such__as_—>__Physicechemicel faopertica
Re ibid) Quality Athi butes-
X Trade felated infomation tte

= © | vadment stage xr gegins with a rh |
Im run of me innaiator produc

Also involve intial Compahbil gwen
pahbiity study
Mug € eipien to be dl in format

STH Pacman sage ma ge pesar ui Hg
O —iy-tro_ similany

26. Me innovator product fr à Fick sates
+ — io" + |
J] ta vive ar >" Ome à phat watch af -
[generic practice an ne |
Bioequvad ence tat T5 conducted on
rs

TL To check he therapeuti =:
ceneric_ pug faa mue OS

fl The _ generic Product Dee el fit
: ss A vel loveing_

D log candisate selection] -+

O, Candidate Omg Sacening
"| 8 concept _ pevel opment

D system level Design

D! Detail Design
O. concept __ testing —

O Business AneSysis > Cómiucion [Ramp up)
_® Development of a Prototype 7
_Ö| peuetopment of a Technology
© Registration
Launch.

J Selection | > in Ms phase
E sac) tae en a Dedicated
pet tam & |

A bem
to selection _ multiple sdluhion oe

¡gen ay ae ment st Sin
a ee he brood selection of F

[4

+

27. y A Kam Deciaes which ng candidate
Y | pe selected: to pmceci info prelimina:

à
In ANS phase >
selected m me)

phase —

is carey examined 0 pay” asses
= + WA potential Drug Condidades
3 simple shetagy ¡Accept! ne [eesti E Sees >
== Ane_ or!

— 21 Development Prceeds with ay one or teo
candidate dor the nert Phase

_® | Longt development > 4
——l U is an _excenise in
which Me Screened _ Candidate bug: is sr
inte the product concept
concept 5 A Petailed vean
the product idea.
mer this phase the needs of he oct
if _ identified, _Altemative product pa ae
=a feel ond evaluated |
= hee ae
nda Simple _pevelepment — is selected Br — ı
—hyther Development - _—
[A amet is the Pesutiption — af them A
function, € hatues of a Pnau 4

28. og ma y Dis phase includes

e = posi —
the division of te Product in (sabe
and. components.
Te Anal formutation Gcheme) qua fo he

Production system is way defined dino this =
me ay ing nis
Tre loudpatl of this phase is a prue layout tit, |
Aunctional_ specifications of each of the Product |
Components

Lai peignl — This phase includes the cemplele
specication, of the matoials and limits of
= au the components in the Product
ab
And identifcahm of au the Pmbanle suppüers. |
The output of this phase is tte Gntml
—____ decumentation dor the product. =)

© [en m ept_Testing| > Ths phrase is the _laboratory.
ne of a generic fmdud |]

Mis phase start with experimental and Accelerated
Stublity Si work.

Me Development Basel on | sede, —
metuding the Piet) a tudy . ES

29. > _@

0 ousses —Anatgasl Zum

3 pis a significant Prose hr weg

= lanizahon
mE: ae: ‘and milestones of the Product
: Development Process
y
Ana time Required For the completion shoud ay
Anes

> da Also, in Anis phase, the impact or Delay A,
“ime of dut anal in the Market ane,

Analyzed Carchuty

® | foeuelopment lof a IPmtotypel >
men

Ths Phase include
the _ Development oF Aa Prototype. teshng. ga
fotutype , modificañon the frototye, & Act

Pradtchion , :

This Mose is also catted — prpducon_Ramp_<Y

Ht also peschbes the Period from completed

inibol Product Pevelopment
y
+o maximum Capauty untizahon.

© Developments of Technolegal >
7 This pase incudd

‘ne Reparation of Registration documentation
& the transfer to the mausty, meute

Y Includes clinical dugies, too logia! suit
— Bioeqivatent studies, & completed sony PA

30. Phase ished with the
Registration _Satches .

Producton of three |

8, [Registration] > Registration is a phase of
. of Regen ee San
Zt _Anishes when the Product iS registered and he
Registration clycumentation © Marketing Autharization
is obtained. =

Cuaunch | > The tounch Phase indudes au
Ahmed pre-launch activities such as =
> ordeung of material
2 Production of launch Stock ___
” ordering of _Reuo material.
Y Packaging Material ec
> In Anís phase the generic Products ame launched
tp the market

© A