Biokimia Bahan Makanan

(KI-5261)

Bagian I
Pokok Bahasan
1.  Peraturan/perundangan untuk Obat dan Bahan
Pangan
2.  Nutrisi:
a)  Makronutrien:
b)  Mikronutrien:
3.  Mikroba sebagai materi biokimia:
a)  Pendahuluan
b)  Peran mikroba
4.  Pengolahan & Pengawetan Bahan Pangan
5.  Senyawa tambahan & Pengotor bahan Pangan
 Buku Rujukan/Refferences
n  Yildiz F., “Advance in Food n  Frazier Q dan Westhoff D.C,
Biochemistry”, CRC Press, “Food Microbiology”,
London, 2010 McGraw-Hill International,
n  Vaclavik, V.A, & Christian Singapore, 1988
E.W., “Essentials of Food
Science”, 3rd ed,. Springer,
San Marcos, 2008 n  Stryer, L, (1995) Biochemistry,
4th ed., WH Freeman and Co.,
n  Jurnal Food Technolgy & New York
Food and Drug Analysis
n  Belitz H. D & Grosch W.,
“Food Chemistry”,
translator: M.M.
Burghagen, 3rd revised ed.,
Springer Verlag, Berlin,
2004
Peraturan dan Perundangan
Bahan Pangan dan Obat
1.  Peraturan/perundangan untuk Obat dan
Bahan Pangan
n  Peraturan/perundangan untuk n  POM
obat dan bahan pangan di tiap n  Balai kliring Keamanan
negara diatur oleh suatu badan Hayati Indonesiaà
tertentu, misal FDA (USA), UNDANG-UNDANG
Canadian Food Inspection REPUBLIK INDONESIA
NOMOR 7 TAHUN
Agency (Canada), Badan POM 1996 :TENTANG PANGAN
(INA) n  SNII
n  Food and Drug Administration n  HACCP (Hazard Analysis
(FDA) Critical Control Points)
n  Sejarah n  ISO 10011 (panduan untuk
n  Obat baru harus melalui uji mengaudit sistem kualitas)
klinis sebelum mendapatkan dari produsen obat/bahan
‘persetujuan obat pangan
baru’ (New Drug
Approval /NDA) dari FDA.
Uji klinis ini terdiri dari 3-4
tahap.
The Food and Drug
Administration
n  Is a public health agency
n  Inspects food (ensureing thati it is safte and
wholesome), cosmetics, medicines and medical
divices, radiation-emitting devices (e.g
microwave ovens). Animal feed, and drugs
n  Advising state and local agencies in general
duties and preventon of disasters à has both
regulatory arms of enforcement and cooperativity
programs of partnership with industry.
Several major amendments to the Food, Drug, and Cosmetic Act that were
introduced and became law.
 Clinical Research
n  How are experimental drugs tested in humans? –
3-4 steps
n  A Phase One Study:
n  concerned with assessing the drug's safety.
n  is done in a small number of healthy
volunteers (20 to 100), who are usually paid
for participating in the study. The study is
designed to determine what happens to the
drug in the human body--how it is absorbed,
metabolized, and excreted.
Phase 2
n  may last from several months to two years, and
involve up to several hundred patients.
n  Most phase II studies are randomized trials.
n  the study can provide the pharmaceutical
company and the FDA comparative information
about the relative safety of the new drug, and its
effectiveness.
n  Only about one-third of experimental drugs
successfully complete both phase I and phase II
studies
Phase 3
n  Is tested in several hundred to several thousand patients.
n  This large-scale testing provides the pharmaceutical
company and the FDA with a more thorough
understanding of the drug's effectiveness, benefits, and
the range of possible adverse reactions.
n  Most phase III studies are randomized and blinded trials.
n  Phase III studies typically last several years. Seventy to
90 percent of drugs that enter phase III studies
successfully complete this phase of testing. Once a phase
III study is successfully completed, a pharmaceutical
company can request FDA approval for marketing the
drug.
Post-Marketing -- Late Phase
Three/Phase Four Studies
n  In late phase III/phase IV studies, pharmaceutical
companies have several objectives: (1) studies
often compare a drug with other drugs already in
the market; (2) studies are often designed to
monitor a drug's long-term effectiveness and
impact on a patient's quality of life; and (3) many
studies are designed to determine the cost-
effectiveness of a drug therapy relative to other
traditional and new therapies.
Who pays for clinical research?
n  from both the federal government (through the
National Institutes of Health) and private industry
(pharmaceutical and biotech companies).
n  The sponsor of the research hires physicians, who
may work in a wide variety of health-care settings, to
conduct the clinical trial. Physicians are typically
paid on a per-patient basis. The medical care is often
provided free to the patient. Patients may also be paid
a small fee to participate in a clinical trial.
Interested in participation of
clinical test? à some reasons
n  People who volunteer for phase II and
phase III trials can gain access to promising
drugs long before these compounds are
approved for the marketplace
n  Informed consent form
National Agency of Drug & Food Control
(Badan Pengawasan Obat & Makanan-
BPOM)
Functions include:
n  Setting, regulation, and standardization
n  Licensing and certification in the field of pharmaceutical
industry based on production Means Good
n  Product evaluation before being allowed to circulate
n  Post marketing Vigilance including sampling and
laboratory testing, inspection of production and
distribution facilities, investigation and law enforcement.
n  Pre-audit and post-audit of advertising and product
promotion
n  Research into the implementation of drug control policy
and food
n  Communication, information and public education