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PERENCANAAN &

PENGEMBANGAN PRODUK
 PRODUCT DEVELOPMENT embraces
the work of technical research and
engineering design; PRODUCT
PLANNING on the other hand, is
concerned with estimates of the
magnitude of potential market, estimates
of sales volume, budgeting of costs, and
other matters relating to the economics of
modifying a product line.
Dari bahan alam ke sintetik

 Simplisia zaman ,nenek moyang’ (Digitalis folium, Chinae


cortex, produk jamu, dll.)
 Berkembang ke ekstrak bahan alam (ekstrak Beladonae,
ekstrak Hyoscyami, dll.)
 Isolat Penisilin 1929
 Senyawa hasil sintesis tahun 1930-an (golongan
sulfonamida)
 Antibiotika semi-sintetik (1960-an): turunan penisilin dan
sefalosporin
 Kimia medisinal – Bioteknologi (sintetik, semisintetik,
teknologi DNA rekombinan untuk insulin, interferon, dll.)
 Kembali ke alam (mencari obat asal alam: ekstrak dan isolat
murni)
Product life cycle
Contoh untuk corticosteroid
Kenapa obat berkembang terus?
 Ditemukannya penyakit baru
 Untuk mendapatkan senyawa baru yang lebih
baik/unggul (Risk and benefit ratio yang lebih
baik):
• Perkembangan resistensi mikroba (antibiotika)
• Antibiotika broad spectrum/spesifik (turunan
sefalosporin)
• Potensi dan sifat farmakokinetik yang lebih baik
• Stabilitas yang lebih baik (turunan penisilin,
eritromisin, dll.)
• Ketersediaan hayati yang lebih baik (prednison)
• Therapeutic window yang lebih baik/lebar (dari
Simetidin ke Ranitidin, dari barbital ke benzodiazepin)
Type of Product Strategy

 Market segmentation
 Product differentation
 Product imitation
 Product improvement and renovation
 New product development
Product development schedule

 Selection
 Screening
 Business specification
 Development
 Testing
 Commercialization
Qualitative criteria for product
decision

 Interrelation of demand characteristics with


the existing product line
 Use of company’s distinctive know how
 Use made of common production facilities
 Use of common distribution channels
 Use of common raw materials
 Benefits to existing products
 Aspek legal
PENELITIAN DAN PENGEMBANGAN

 FORMULATION DEVELOPMENT
 ANALYTICAL DEVELOPMENT
 PACKAGING DEVELOPMENT
REQUIREMENTS FOR DEVELOPMENT

 Regulatory requirement
 Technical requirement
 Practical requirement
 Validation requirement
 Transfer requirement
Regulatory requirements

 Standards of quality (specifications)


 Standards of analytical methods
Specifications

 Internal specifications
 External specifications (official/
pharmacopoeial specifications) (FI IV
etc.)
Advertising (to produce an awareness)

 Media (media cetak dan elektronik)


 Medical exhibit
 Direct mail
 Direct detailing
Pemilihan cara advertising

 Jenis produk (ethical vs. OTC)


 Peraturan/regulasi yang berlaku
 Efektivitas
Pricing and Competition

 Non-price competition
 Price and quasi-price competition
Non-price competition

 Patent
 Trademark
 Quality competition
 Research and development competition