KONSEP DASAR PENELITIAN DAN

PENGEMBANGAN

URIP HARAHAP

PROGRAM MAGISTER ILMU FARMASI

2019
 What Does Research And
Development - R&D Mean?
● Research and development (R&D) refers to the activities
companies undertake to innovate and introduce new products and
services. ...
● It is often the first stage in the development process. The goal is typically
to take new products and services to market and add to the company's
bottom line.
● Pharmaceuticals, semiconductor, and software/technology companies
tend to spend the most on R&D. In Europe, R&D is known
as research and technical or technological development (RTD).
 What Does Research And
Development - R&D Mean?
● Kegiatan investigasi yang dilakukan secara
sistematis dan intensif untuk menemukan dan
atau mengembangkan produk atau prosedur
baru, atau memperbaiki produk atau
prosedur yang sudah ada
● R &D adalah salah satu strategi untuk
mengembangkan produk atau proses baru
berdasarkan pengalaman untuk memperbaiki
dan memperluas operasional sauatu bisnis
(industri)
 Definisi Riset dan Pengembangan
❑ Research: Proses identifikasi obat, pestisida atau
kandidat biologis dengan tahapan:
● Discovery, screening, and pre-clinical testing
● Dose determination (PK, laboratory efficacy studies)
● Preliminary safety and effectiveness data
● Objective = product with predictable outcomes
❑ Development
● Safety dan efektivitas mesti dibuktikan pada studi
terkontrol, yaitu:
● Aman pada spesies target
● Label claims harus didukung oleh data pengembangan
● R&D is separate from most operational activities
performed by a corporation. The research and/or
development is typically not performed with the
expectation of immediate profit. Instead, it is expected to
contribute to the long-term profitability of a
company. R&D may lead to patents, copyrights, and
trademarks as discoveries are made and products
created.
● Companies that set up and employ entire R&D departments
commit substantial capital to the effort.
● They must estimate the risk-adjusted return on their R&D
expenditures—which inevitably involves risk of capital—because
there is no immediate payoff, and the return on
investment (ROI) is uncertain.
● As more money is invested in R&D, the level of capital risk
increases. Other companies may choose to outsource their R&D
for a variety of reasons including size and cost
 Basic Research Versus Applied
Research
● Basic research is aimed at a fuller, more complete
understanding of the fundamental aspects of a concept or
phenomenon. This understanding is generally the first
step in R&D. These activities provide a basis of
understanding and information without directed
applications toward products, policies, or operational
processes.
● Applied research entails the activities used to gain
knowledge with a specific goal in mind. The activities may
be to determine and develop new products, policies, or
operational processes. While basic research is
time-consuming, applied research is painstaking and
more costly because of its detailed and complex nature
 RISET DAN PENGEMBANGAN OBAT (R & D)
PENGEMBANGAN OBAT
BARU DARI OBAT YANG PENDEKATAN MARKET
SUDAH ADA

• FERMENTASI
R&D
• SINTESIS
PENCARIAN BAHAN BAKU
UNTUK OBAT BARU • ISOLASI DARI BHN ALAM

Penemuan senyawa produk alam dilakukan dengan:

• Penapisan secara masal dari bahan alam
• Isolasi
• Pemurnian senyawa yang terkandung
• Penentuan struktur kimia
• Uji biologis (bio assay) dengan metode yang sesuai (in vitro, in situ, in vivo) sehingga
diperoleh senyawa penuntun (Lead compound)
• Lead compound dikembangkan lebih lanjut melalui modifikasi molekul sehingga
diperoleh derivasi senyawa dengan aktivitas yang diinginkan

Di seluruh dunia terdapat sekitar 600.000 jenis tumbuhan (400.000 di antaranya tumb. tinggi),
baru sekitar 10% yang telah diteliti secara kimia dan farmakologi
 New Drug:

• Suatu senyawa kimia atau substans yang sebelumnya belum

pernah digunakan pada manusia untuk mentritmen penyakit
• Kombinasi obat yang telah disetujui atau obat yang telah lama
digunakan tetapi masih baru bagi orang tertentu
• Obat yang telah disetujui digunakan selain penggunaan yang
sebelum di setujui
• Sediaan obat (baru) yang disetujui digunakan sebagai obat;
• Obat yang digunakan secara in vitro sebagai agen diagnostik
atau tritmen penyakit pada manusia
 Pegembangan R&D
obat.ppt
Pencarian senyawa obat baru

Sintesis Isolasi Fermenetasi

Interface
Research
Substans
drug Riset:
•Farmakologi
Riset Teknologi

•Klinik Phases Dev.ppt

farmaseutik

Disain yg tepat Formulasi •Toksikologi

Sesuai dengan Manufaktur

dosageform
Dosageform Marketing

•Bau
•Rasa Akseptabilitas Efektivitas Safety
•Penampilan

KUALITAS MEDIKAMENT
 Rujukan

1. https://www.investopedia.com/terms/r/randd.asp
2. https://www.slideshare.net/AnuragPandey60/histo
ry-of-computers-in-pharmaceutical-research-devel
opment-94907249